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Yang H, Yang L, Jardine MJ, Arnott C, Neuen BL, Xu K, Zhao X, Qian D, Cui B, Qiu Y, Huang Y, Yu J, Wang J, Yu S, Tan H, Huang L, Li JW, Jin J. The association between sodium-glucose cotransporter 2 inhibitors and contrast-associated acute kidney injury in patients with type 2 diabetes undergoing angiography: a propensity-matched study. Eur J Med Res 2024; 29:621. [PMID: 39719658 PMCID: PMC11667978 DOI: 10.1186/s40001-024-02214-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2024] [Accepted: 12/09/2024] [Indexed: 12/26/2024] Open
Abstract
BACKGROUND Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been proven to prevent decline in kidney function and failure. Whether SGLT2i affect the risk of contrast-associated acute kidney injury (CA-AKI) remains uncertain. METHODS Use of SGLT2i was assessed in consecutive diabetics undergoing coronary angiography (CA) or percutaneous coronary intervention (PCI) from January 2020 to May 2023 at a tertiary hospital in Chongqing, China. Propensity-matched analysis was used to adjust for baseline variables. CA-AKI was defined by the Acute Kidney Injury Network (AKIN) as creatinine increase ≥ 0.3 mg/dl (26.4 μmol/l), or a percentage increase in the serum creatinine level of ≥ 50%. RESULTS A total of 604 new users of SGLT2i, and 298 chronic users of SGLT2i were matched with non-users. New use of SGLT2i was not associated with an increased incidence of AKIN-defined CA-AKI (OR 1.60; 95% CI 0.97-2.63; p = 0.065), in-hospital new-onset dialysis (OR 0.50; 95% CI 0.09-2.73; p = 0.422), or death (OR 0.55; 95% CI 0.18-1.66; p = 0.289). However, it was associated with a minor (> 25%) creatinine elevation (OR 1.55; 95% CI 1.04-2.30; p = 0.030), a 0.3 mg/dl increase in creatinine (OR 1.66; 95% CI 1.01-2.75; p = 0.048), and CMSC-defined CA-AKI (OR 1.51; 95% CI 1.02-2.24; p = 0.039). By 90 days, there was no evidence creatinine elevation differed between the two groups (p = 0.590). Chronic use of SGLT2i was not associated with AKIN-defined CA-AKI (OR, 0.92; 95% CI 0.41-2.05; p = 0.838). CONCLUSIONS New use of SGLT2i during CA or PCI was not associated with an AKIN-defined CA-AKI, and it did not translate into new-onset dialysis or death during hospital stay. Chronic usage of SGLT2i did not affect creatinine. Further randomized clinical trials are warranted to confirm this finding.
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Affiliation(s)
- Hao Yang
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Lili Yang
- Department of Information, Xinqiao Hospital, Army Medical University, Chongqing, China
| | - Meg J Jardine
- The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
- Trials Centre, NHMRC Clinical, University of Sydney, Sydney, NSW, Australia
- Department of Renal Medicine, Concord Repatriation General Hospital, Sydney, NSW, Australia
| | - Clare Arnott
- The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
- Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
| | - Brendon L Neuen
- The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
| | - Kexi Xu
- Department of Information, Xinqiao Hospital, Army Medical University, Chongqing, China
| | - Xiaohui Zhao
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Dehui Qian
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Bin Cui
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Youzhu Qiu
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Yuli Huang
- The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
- Department of Cardiology, Shunde Hospital, Southern Medical University, Foshan, China
| | - Jie Yu
- The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
- Cardiovascular Department, John Hunter Hospital, Newcastle, NSW, Australia
- Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia
| | - Jiang Wang
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Shiyong Yu
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Hu Tan
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Lan Huang
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China
| | - Jing-Wei Li
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China.
- The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
| | - Jun Jin
- Department of Cardiology, Xinqiao Hospital, Army Military Medical University, No. 83 Xinqiao Street, Shapingba District, Chongqing, 400037, China.
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Owolabi EO, Boakye MDS, Omololu SO, Smalls BL, Shaibi GQ. Technology-Based Interventions to Promote Diabetes Self-Management Behaviors for Persons Newly Diagnosed with Type 2 Diabetes: A Scoping Review. Curr Diab Rep 2024; 24:257-272. [PMID: 39352613 DOI: 10.1007/s11892-024-01553-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/23/2024] [Indexed: 10/12/2024]
Abstract
PURPOSE OF REVIEW Type 2 diabetes (T2D) management is complex and requires daily personal involvement and self-management skills to maintain optimal glycemic levels and improve health outcomes. Engagement in self-management behaviors in the early years of diagnosis can be challenging due to prevailing psychosocial factors present during this critical transition period, coupled with a lack of information, support, and skills. Technology-based diabetes self-management interventions can improve access to needed education and support, and their effectiveness in the general T2D population is well documented. This scoping review synthesized evidence on the use of technology for promoting diabetes self-management behaviors and related outcomes among individuals newly diagnosed with T2D (within the first 12 months since diagnosis). RECENT FINDINGS Twenty-five studies were included. Technology-based diabetes self-management interventions tailored to those newly diagnosed with T2D have grown exponentially in the past five years. Existing evidence, though limited, showed that technologies such as websites, mobile apps, and continuous glucose monitoring combined with other communication features, can facilitate patient education, patient-provider communication, and health data monitoring. However, these technologies less commonly involved social support functions. These technologies have the potential to improve diabetes knowledge and positively impact clinical, behavioral, and psychological outcomes. However, small sample sizes, use of non-experimental designs, and the absence of formative research and theoretical foundations limit the strength of existing studies. Technology-based self-management interventions for those newly diagnosed with T2D show promise in improving T2D-related outcomes. Future studies should include larger sample sizes, adopt rigorous study designs, and integrate formative work to enhance relevance, adoption, and impact.
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Affiliation(s)
- Eyitayo O Owolabi
- Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, USA.
| | - Michelle D S Boakye
- Manning College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA
| | | | - Brittany L Smalls
- Department of Family and Community Medicine, College of Medicine, University of Kentucky, Lexington, KY, USA
| | - Gabriel Q Shaibi
- Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, USA
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Gaid D, Giasson G, Gaboury I, Houle L, Layani G, Menear M, de Tilly VN, Pomey MP, Vachon B. Quality priorities related to the management of type 2 diabetes in primary care: results from the COMPAS + quality improvement collaborative. BMC PRIMARY CARE 2024; 25:397. [PMID: 39550565 PMCID: PMC11568624 DOI: 10.1186/s12875-024-02641-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Accepted: 10/25/2024] [Indexed: 11/18/2024]
Abstract
BACKGROUND This study aims to describe the main type 2 diabetes mellitus (T2DM) quality improvement (QI) challenges identified by primary care teams in the province of Quebec who participated in the COMPAS + QI collaborative. METHODS A qualitative descriptive design was used to analyse the results of 8 COMPAS + workshops conducted in 4 regions of the province between 2016 and 2020. Deductive content analysis was performed to classify the reported QI priorities under the Consolidated Framework for Implementation Research domains; and proposed change strategies under the Behavior Change Wheel (BCW) intervention functions. RESULTS A total of 177 participants attended the T2DM COMPAS + workshops. Three QI priorities were identified: (1) lack of coordination and integration of T2DM care and services; (2) lack of preventive services for pre-diabetes and T2DM; and (3) lack of integration of the patients-as-partners approach to support T2DM self-management. The proposed QI strategies to address those priorities were classified under the education, training, persuasion, habilitation and restructuring BCW intervention functions. CONCLUSION This study provides insights on how QI collaboratives can support the identification of QI priorities and strategies to improve T2DM management in primary care.
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Affiliation(s)
- Dina Gaid
- School of Rehabilitation, Faculty of Medicine, Université de Montréal, CP 6128 Succursale Centre-Ville, Montreal, QC, H3C 3J7, Canada
| | - Guylaine Giasson
- Department of Family Emergency Medicine, Faculty of Medicine and Health Sciences, Centre de recherche Charles-LeMoyne (CR-CRCLM), Université de Sherbrooke - Campus de Longueuil, Longueuil, QC, Canada
| | - Isabelle Gaboury
- Department of Family and Emergency Medicine, Faculty of Medicine and Health Sciences, Centre de recherche Charles-LeMoyne (CR-CRCLM), Université de Sherbrooke Campus de Longueuil, Longueuil, QC, Canada
| | - Lise Houle
- Institut national d'excellence en santé et en services sociaux (INESSS), Montreal, QC, Canada
| | - Géraldine Layani
- Department of Family Medicine and Emergency Medicine, Université de Montréal, Montreal, QC, Canada
- Centre de recherche du Centre hospitalier universitaire de l'Université de Montréal, Montreal, QC, Canada
| | - Matthew Menear
- Department of Family Medicine and Emergency Medicine, Université Laval, Quebec, QC, Canada
- VITAM - Centre de recherche en santé durable, Quebec, QC, Canada
| | | | - Marie-Pascale Pomey
- Centre de recherche du Centre hospitalier universitaire de l'Université de Montréal, Montreal, QC, Canada
- Public Health School, Department of Management, evaluation and health policy, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada
| | - Brigitte Vachon
- School of Rehabilitation, Faculty of Medicine, Université de Montréal, CP 6128 Succursale Centre-Ville, Montreal, QC, H3C 3J7, Canada.
- Centre de recherche du CIUSSS de l'Est de l'Île de Montréal, Montreal, QC, Canada.
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Nabrdalik K, Hendel M, Irlik K, Kwiendacz H, Łoniewski I, Bucci T, Alam U, Lip GYH, Gumprecht J, Skonieczna-Żydecka K. Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: a systematic review and meta-analysis with meta-regression of observational studies. BMC Endocr Disord 2024; 24:206. [PMID: 39350158 PMCID: PMC11440709 DOI: 10.1186/s12902-024-01727-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Accepted: 09/11/2024] [Indexed: 10/04/2024] Open
Abstract
INTRODUCTION Metformin is the most prescribed medication for type 2 diabetes mellitus (T2DM); there is a well-established link with the elevated incidence of gastrointestinal (GI) adverse events (AE) limiting its administration or intensification. OBJECTIVES The objective of this systematic review and meta-analysis of observational studies was to evaluate the pooled incidence of GI AE related to metformin use in patients with T2DM. MATERIALS AND METHODS PUB MED/CINAHL/Web of Science/Scopus were searched from database inception until 29.07.2024 for observational studies in English describing the frequency of GI AE in patients with T2DM treated with metformin. Random-effects meta-analyses were used to derive effect sizes: event rates. RESULTS From 7019 publications, we identified 211 potentially eligible full-text articles. Ultimately, 21 observational studies were included in the meta-analysis. The prevalence of GI AE was as follows: diarrhea 6.9% (95% CI: 0.038-0.123), bloating 6,2% (95% CI: 0.020-0.177), abdominal pain 5,3% (95% CI: 0.003-0.529), vomiting 2.4% (95%: CI 0.007-0.075), constipation 1.1% (95%: CI 0.001-0.100). The incidence of bloating (coefficient -4.46; p < 0.001), diarrhea (coefficient -1.17; p = 0.0951) abdominal pain (coefficient -2.80; p = 0.001), constipation (coefficient -5.78; p = 0.0014) and vomiting (coefficient -2.47; p < 0.001) were lower for extended release (XR) metformin than metformin immediate release (IR) formulation. CONCLUSIONS This study highlights the prevalence of GI AE in patients receiving metformin, with a diarrhea predominance, followed by bloating, diarrhea, abdominal pain, constipation, and vomiting. The incidence is lower in patients administered with XR metformin. TRIAL REGISTRATION https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021289975 , identifier CRD42021289975.
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Affiliation(s)
- Katarzyna Nabrdalik
- Department of Internal Medicine, Diabetology and Nephrology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 3 May Street, Zabrze, Katowice, 41-800, Poland.
- Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK.
| | - Mirela Hendel
- Students' Scientific Association By the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
| | - Krzysztof Irlik
- Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK
- Students' Scientific Association By the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
| | - Hanna Kwiendacz
- Department of Internal Medicine, Diabetology and Nephrology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 3 May Street, Zabrze, Katowice, 41-800, Poland
| | - Igor Łoniewski
- Department of Biochemical Science, Pomeranian Medical University, Szczecin, Poland
| | - Tommaso Bucci
- Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK
- Department of General and Specialized Surgery, Sapienza University of Rome, Rome, Italy
| | - Uazman Alam
- Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK
- Diabetes & Endocrinology Research and Pain Research Institute, Institute of Life Course and Medical Sciences, University of Liverpool and Liverpool University Hospital NHS Foundation Trust, Liverpool, UK
- Centre for Biomechanics and Rehabilitation Technologies, Staffordshire University, Stoke-On-Trent, UK
| | - Gregory Y H Lip
- Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
| | - Janusz Gumprecht
- Department of Internal Medicine, Diabetology and Nephrology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 3 May Street, Zabrze, Katowice, 41-800, Poland
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Huang Y, Yu Y, Hu R, Xu K, Wang T, Ling H, Han J, Lv D. Predictors of glycemic and weight responses to exenatide in patients with type 2 diabetes mellitus. Int J Diabetes Dev Ctries 2024; 44:328-334. [DOI: 10.1007/s13410-023-01239-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/26/2022] [Accepted: 08/23/2023] [Indexed: 01/04/2025] Open
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Ma S, Frecklington M, Stewart S. The use of antimicrobial dressings for the management of diabetic foot ulcers: A survey of podiatrists in Aotearoa New Zealand. J Foot Ankle Res 2024; 17:e12032. [PMID: 38884388 PMCID: PMC11296712 DOI: 10.1002/jfa2.12032] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2024] [Accepted: 06/03/2024] [Indexed: 06/18/2024] Open
Abstract
INTRODUCTION Diabetic foot ulcers (DFUs) are commonly contaminated with pathogenic organisms and precede most diabetes-related amputations. Antimicrobial dressings are used in the treatment of DFUs; however, recent guidelines do not support their use. There are no data describing the experience of antimicrobial dressing use among podiatrists in Aotearoa New Zealand (AoNZ). This study aimed to (i) determine which antimicrobial dressings podiatrists in AoNZ use for the management of diabetic foot ulcers; and (ii) determine what factors influence AoNZ podiatrists' use of antimicrobial dressing when managing DFUs. METHODS An anonymous cross-sectional web-based survey was undertaken. Participants were AoNZ registered podiatrists who managed DFUs in their practice. The survey included questions relating to personal and professional demographic characteristics and DFU management and dressing practices. Descriptive statistics were computed to address the research aims. RESULTS Responses from 43 AoNZ podiatrists were included. Participants reported both cadexomer iodine and silver dressings were the most common antimicrobial dressings used, with honey dressings being the least frequently used. The most influential factors in choosing antimicrobial dressings when managing DFUs were the presence of current infection, ulcer exudate and ability to prevent future infection. The least influential factors in choosing antimicrobial dressings when managing DFUs were patient preferences, cost of dressings and comfort of dressing/pain on removal. CONCLUSIONS AoNZ podiatrists managing DFUs primarily use antimicrobial dressings containing cadexomer iodine or silver as active ingredients, while lower-cost options, such as honey and povidone iodine are less often used. Current recommendations highlight the lack of evidence to support positive outcomes from any particular antimicrobial dressing over another and advocate that exudate control, comfort and cost be prioritised in decision-making. As cost has been an increasing burden to our healthcare funding, clinicians and organisations may consider this before purchasing and stocking expensive dressings.
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Affiliation(s)
- Skye Ma
- School of Clinical SciencesFaculty of Health and Environmental SciencesAuckland University of TechnologyAucklandNew Zealand
| | - Mike Frecklington
- School of Clinical SciencesFaculty of Health and Environmental SciencesAuckland University of TechnologyAucklandNew Zealand
- Active Living and Rehabilitation: Aotearoa New ZealandHealth and Rehabilitation Research InstituteSchool of Clinical SciencesAuckland University of TechnologyAucklandNew Zealand
| | - Sarah Stewart
- School of Clinical SciencesFaculty of Health and Environmental SciencesAuckland University of TechnologyAucklandNew Zealand
- Active Living and Rehabilitation: Aotearoa New ZealandHealth and Rehabilitation Research InstituteSchool of Clinical SciencesAuckland University of TechnologyAucklandNew Zealand
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Gillett AC, Hagenaars SP, Handley D, Casanova F, Young KG, Green H, Lewis CM, Tyrrell J. The impact of major depressive disorder on glycaemic control in type 2 diabetes: a longitudinal cohort study using UK Biobank primary care records. BMC Med 2024; 22:211. [PMID: 38807170 PMCID: PMC11134616 DOI: 10.1186/s12916-024-03425-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/12/2023] [Accepted: 05/15/2024] [Indexed: 05/30/2024] Open
Abstract
BACKGROUND This study evaluates longitudinal associations between glycaemic control, measured by mean and within-patient variability of glycated haemaglobin (HbA1c) levels, and major depressive disorder (MDD) in individuals with type 2 diabetes (T2D), focusing on the timings of these diagnoses. METHODS In UK Biobank, T2D was defined using self-report and linked health outcome data, then validated using polygenic scores. Repeated HbA1c measurements (mmol/mol) over the 10 years following T2D diagnosis were outcomes in mixed effects models, with disease duration included using restricted cubic splines. Four MDD exposures were considered: MDD diagnosis prior to T2D diagnosis (pre-T2D MDD), time between pre-T2D MDD diagnosis and T2D, new MDD diagnosis during follow-up (post-T2D MDD) and time since post-T2D MDD diagnosis. Models with and without covariate adjustment were considered. RESULTS T2D diagnostic criteria were robustly associated with T2D polygenic scores. In 11,837 T2D cases (6.9 years median follow-up), pre-T2D MDD was associated with a 0.92 increase in HbA1c (95% CI: [0.00, 1.84]), but earlier pre-T2D MDD diagnosis correlated with lower HbA1c. These pre-T2D MDD effects became non-significant after covariate adjustment. Post-T2D MDD individuals demonstrated increasing HbA1c with years since MDD diagnosis ( β = 0.51 , 95% CI: [0.17, 0.86]). Retrospectively, across study follow-up, within-patient variability in HbA1c was 1.16 (95% CI: 1.13-1.19) times higher in post-T2D MDD individuals. CONCLUSIONS The timing of MDD diagnosis is important for understanding glycaemic control in T2D. Poorer control was observed in MDD diagnosed post-T2D, highlighting the importance of depression screening in T2D, and closer monitoring for individuals who develop MDD after T2D.
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Affiliation(s)
- Alexandra C Gillett
- Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
- NIHR Maudsley Biomedical Research Centre, South London and Maudsley NHS Trust, London, UK.
| | - Saskia P Hagenaars
- Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
- NIHR Maudsley Biomedical Research Centre, South London and Maudsley NHS Trust, London, UK
| | - Dale Handley
- Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Francesco Casanova
- Clinical and Biomedical Science, Institute of Health and Life Sciences, University of Exeter, Exeter, UK
| | - Katherine G Young
- Clinical and Biomedical Science, Institute of Health and Life Sciences, University of Exeter, Exeter, UK
| | - Harry Green
- Clinical and Biomedical Science, Institute of Health and Life Sciences, University of Exeter, Exeter, UK
| | - Cathryn M Lewis
- Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
- NIHR Maudsley Biomedical Research Centre, South London and Maudsley NHS Trust, London, UK
- Department of Medical and Molecular Genetics, Faculty of Life Sciences and Medicine, King's College London, London, UK
| | - Jess Tyrrell
- Clinical and Biomedical Science, Institute of Health and Life Sciences, University of Exeter, Exeter, UK
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Donnelly HR, Clarke ED, Collins CE, Tehan PE. 'Nutrition has everything to do with wound healing'-health professionals' perceptions of assessment and management of nutrition in individuals with diabetes-related foot ulceration. Int Wound J 2024; 21:e14898. [PMID: 38745257 PMCID: PMC11093920 DOI: 10.1111/iwj.14898] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2024] [Accepted: 04/19/2024] [Indexed: 05/16/2024] Open
Abstract
Determine how healthcare professionals perceive their role in nutrition assessment and management, and explore barriers and enablers to assessment and management of nutrition in individuals with DFU. Mixed methods including a cross-sectional online survey derived from current international guidelines and theoretical domains framework, and semi-structured interviews with conventional content analysis was performed. One hundred and ninety-one participants completed the survey, with 19 participating in interviews. Many health professionals are not confident in their ability in this area of practice, are uncertain their nutrition advice or management will be effective in assisting wound healing outcomes and are uncertain their intervention would result in adequate behaviour change by the individual with DFU. Major barriers to implementation of nutrition assessment and management were: inadequate time, lack of knowledge and lack of clinical guidance and enablers were as follows: professional development, a standardised clinical pathway and screening tool and a resource addressing wound healing and diabetes management. Nutrition assessment and management in individuals with DFU is not consistently applied. Whilst health professionals believed nutrition was important for wound healing, they lacked confidence in implementing into their practice. Further dissemination of existing guidance and implementation of education programs and resources would help overcome cited barriers.
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Affiliation(s)
- Hailey R. Donnelly
- School of Health Sciences, College of Health, Medicine and WellbeingUniversity of NewcastleCallaghanNew South WalesAustralia
- Food and Nutrition Research ProgramHunter Medical Research InstituteNew Lambton HeightsNew South WalesAustralia
| | - Erin D. Clarke
- School of Health Sciences, College of Health, Medicine and WellbeingUniversity of NewcastleCallaghanNew South WalesAustralia
- Food and Nutrition Research ProgramHunter Medical Research InstituteNew Lambton HeightsNew South WalesAustralia
| | - Clare E. Collins
- School of Health Sciences, College of Health, Medicine and WellbeingUniversity of NewcastleCallaghanNew South WalesAustralia
- Food and Nutrition Research ProgramHunter Medical Research InstituteNew Lambton HeightsNew South WalesAustralia
| | - Peta E. Tehan
- Food and Nutrition Research ProgramHunter Medical Research InstituteNew Lambton HeightsNew South WalesAustralia
- Department of Surgery, School of Clinical SciencesMonash UniversityMelbourneVictoriaAustralia
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Goudswaard LJ, Smith ML, Hughes DA, Taylor R, Lean M, Sattar N, Welsh P, McConnachie A, Blazeby JM, Rogers CA, Suhre K, Zaghlool SB, Hers I, Timpson NJ, Corbin LJ. Using trials of caloric restriction and bariatric surgery to explore the effects of body mass index on the circulating proteome. Sci Rep 2023; 13:21077. [PMID: 38030643 PMCID: PMC10686974 DOI: 10.1038/s41598-023-47030-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2023] [Accepted: 11/08/2023] [Indexed: 12/01/2023] Open
Abstract
Thousands of proteins circulate in the bloodstream; identifying those which associate with weight and intervention-induced weight loss may help explain mechanisms of diseases associated with adiposity. We aimed to identify consistent protein signatures of weight loss across independent studies capturing changes in body mass index (BMI). We analysed proteomic data from studies implementing caloric restriction (Diabetes Remission Clinical trial) and bariatric surgery (By-Band-Sleeve), using SomaLogic and Olink Explore1536 technologies, respectively. Linear mixed models were used to estimate the effect of the interventions on circulating proteins. Twenty-three proteins were altered in a consistent direction after both bariatric surgery and caloric restriction, suggesting that these proteins are modulated by weight change, independent of intervention type. We also integrated Mendelian randomisation (MR) estimates of the effect of BMI on proteins measured by SomaLogic from a UK blood donor cohort as a third line of causal evidence. These MR estimates provided further corroborative evidence for a role of BMI in regulating the levels of six proteins including alcohol dehydrogenase-4, nogo receptor and interleukin-1 receptor antagonist protein. These results indicate the importance of triangulation in interrogating causal relationships; further study into the role of proteins modulated by weight in disease is now warranted.
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Affiliation(s)
- Lucy J Goudswaard
- Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK.
- MRC Integrative Epidemiology Unit, Bristol, UK.
- Physiology, Pharmacology & Neuroscience, University of Bristol, Biomedical Sciences Building, University Walk, Bristol, BS8 1TD, UK.
| | - Madeleine L Smith
- Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK
- MRC Integrative Epidemiology Unit, Bristol, UK
| | - David A Hughes
- Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK
- MRC Integrative Epidemiology Unit, Bristol, UK
| | - Roy Taylor
- Newcastle Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, NE4 5PL, UK
| | - Michael Lean
- Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary & Life Sciences, University of Glasgow, Glasgow, G31 2ER, UK
| | - Naveed Sattar
- School of Cardiovascular and Medical Science, University of Glasgow, Glasgow, G12 8TA, UK
| | - Paul Welsh
- School of Cardiovascular and Medical Science, University of Glasgow, Glasgow, G12 8TA, UK
| | - Alex McConnachie
- Robertson Centre for Biostatistics, School of Health and Wellbeing, University of Glasgow, Glasgow, G12 8QQ, UK
| | - Jane M Blazeby
- Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK
| | - Chris A Rogers
- Bristol Medical School, Bristol Trials Centre, University of Bristol, Bristol, BS8 1NU, UK
| | - Karsten Suhre
- Department of Biophysics and Physiology, Weill Cornell Medicine - Qatar, Doha, Qatar
| | - Shaza B Zaghlool
- Department of Biophysics and Physiology, Weill Cornell Medicine - Qatar, Doha, Qatar
| | - Ingeborg Hers
- Physiology, Pharmacology & Neuroscience, University of Bristol, Biomedical Sciences Building, University Walk, Bristol, BS8 1TD, UK
| | - Nicholas J Timpson
- Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK
- MRC Integrative Epidemiology Unit, Bristol, UK
| | - Laura J Corbin
- Population Health Sciences, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK
- MRC Integrative Epidemiology Unit, Bristol, UK
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10
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Charles JA, Wood NI, Neary S, Moreno JO, Scierka L, Brink B, Zhao X, Gielissen KA. "Zoom"ing to the Kitchen: A Novel Approach to Virtual Nutrition Education for Medical Trainees. Nutrients 2023; 15:4166. [PMID: 37836450 PMCID: PMC10574391 DOI: 10.3390/nu15194166] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2023] [Revised: 09/06/2023] [Accepted: 09/22/2023] [Indexed: 10/15/2023] Open
Abstract
While nutritional interventions are first-line therapy for many chronic diseases, most medical trainees receive minimal nutrition education, leaving them unprepared to address nutritional issues with patients. An interactive, single-session, virtual nutrition curriculum was taught online to 80 physician assistant (PA) students. Topics included plant-based nutrition, dietary history-taking and counseling, and culinary medicine. Students were surveyed before, immediately after, and four weeks after the curriculum to assess changes to nutrition-related knowledge, attitudes, confidence, and personal dietary behaviors. Seventy-three PA students (91%) completed the pre-survey, 76 (95%) completed the post-survey, and 42 (52.5%) completed the delayed post-survey. Knowledge scores increased immediately post-intervention (48.9% to 78.9%; p < 0.001) and persisted four weeks later (78.9% to 75.8%; p = 0.54). Post-intervention, students felt more confident in dietary history-taking (55% vs. 95%; p = 0.001) and nutrition counseling (53% vs. 84%; p = 0.003) and agreed that dietary changes alone could reverse type 2 diabetes (74% vs. 97%; p = 0.027) and coronary artery disease (66% vs. 92%; p = 0.039). Curricula using virtual teaching kitchens may be a scalable approach to nutrition education for medical trainees.
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Affiliation(s)
- Justin A. Charles
- Department of Family Medicine and Public Health, UC San Diego Health, San Diego, CA 92093, USA
| | - Nathan I. Wood
- Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06520, USA; (N.I.W.); (J.O.M.); (L.S.)
| | - Stephanie Neary
- Physician Assistant Online Program, Yale University School of Medicine, New Haven, CT 06520, USA;
| | - Jorge O. Moreno
- Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06520, USA; (N.I.W.); (J.O.M.); (L.S.)
| | - Lindsey Scierka
- Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06520, USA; (N.I.W.); (J.O.M.); (L.S.)
| | - Benjamin Brink
- Department of Internal Medicine, Brown University-Rhode Island Hospital, Providence, RI 02912, USA
| | - Xiwen Zhao
- Yale Center for Analytical Sciences, Yale University School of Public Health, New Haven, CT 06511, USA;
| | - Katherine A. Gielissen
- Division of General Internal Medicine, Emory University School of Medicine, Atlanta, GA 30303, USA;
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11
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Tay D, Chua M, Khoo J. Validity of the short-form five-item Problem Area in Diabetes questionnaire as a depression screening tool in type 2 diabetes mellitus patients. J Diabetes Investig 2023; 14:1128-1135. [PMID: 37409708 PMCID: PMC10445190 DOI: 10.1111/jdi.14051] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2023] [Revised: 04/11/2023] [Accepted: 05/03/2023] [Indexed: 07/07/2023] Open
Abstract
AIMS/INTRODUCTION Depression is prevalent in diabetes patients and associated with poor outcomes, but is currently underdiagnosed, with no firm consensus on screening methods. We evaluated the validity of the short-form five-item Problem Areas in Diabetes (PAID-5) questionnaire as a screening tool for depression, comparing it with the Beck Depression Inventory-II (BDI-II) and nine-item Patient Health Questionnaire (PHQ-9). MATERIALS AND METHODS A total of 208 English-speaking adults with type 2 diabetes, recruited from outpatient clinics, completed the BDI-II, PHQ-9 and PAID-5 questionnaires in English. Cronbach's α was used for internal reliability. Convergent validity was examined with BDI-II and PHQ-9. Receiver operating characteristics analyses were used to identify optimal PAID-5 cut-offs for the diagnosis of depression. RESULTS All three screening tools were highly reliable, with BDI-II, PHQ-9 and PAID-5 having a Cronbach's α of 0.910, 0.870 and 0.940, respectively. There was a good correlation between BDI-II and PHQ-9, with a correlation co-efficient (r) of 0.73; and a moderate correlation between PAID-5 and PHQ-9, and PAID-5 and BDI-II, with r of 0.55 and 0.55 respectively (P values <0.01). An optimal PAID-5 cut-off ≥9 corresponded to both a BDI-II cut-off >14 (sensitivity 72%, specificity 784%, area under the curve 0.809) and a PHQ-9 cut-off >10 (sensitivity 84%, specificity 74%, area under the curve 0.806). Using a PAID-5 cut-off ≥9, the prevalence of depressive symptoms was 36.1%. CONCLUSIONS Depressive symptoms are prevalent in people with type 2 diabetes, with the degree of distress significantly related to the severity of depressive symptoms. PAID-5 is a valid and reliable screening tool, and a score ≥9 could prompt further confirmation for depression.
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Affiliation(s)
- Donovan Tay
- Department of EndocrinologySengkang General HospitalSingapore
| | - Marvin Chua
- Department of EndocrinologySengkang General HospitalSingapore
| | - Joan Khoo
- Department of EndocrinologyChangi General HospitalSingapore
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12
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Büssgen M, Stargardt T. 10 Years of AMNOG: What is the Willingness-to-Pay for Pharmaceuticals in Germany? APPLIED HEALTH ECONOMICS AND HEALTH POLICY 2023; 21:751-759. [PMID: 37249741 PMCID: PMC10227403 DOI: 10.1007/s40258-023-00815-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 05/11/2023] [Indexed: 05/31/2023]
Abstract
OBJECTIVES The German Pharmaceutical Market Restructuring Act (AMNOG, 2011) is a two-stage process to regulate the price of new pharmaceuticals in which price negotiations are conducted based on evidence-based medical benefit assessments using data from prior clinical trials. Although the act does not explicitly set a willingness-to-pay (WTP) threshold, the process itself implicitly establishes a WTP for health improvement. We evaluated the implicit WTP for prescription pharmaceuticals post-AMNOG in the German healthcare system from the decision-maker/payer perspective. METHODS We extracted data on patient-group-specific annual treatment costs and endpoints from 2011 to 2021 from the dossiers assessed by the German Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss). Using incremental cost-effectiveness ratios (ICERs), we calculated a WTP for the indications (I) diabetes, (II) cardiovascular disease, and (III) psoriasis weighted according to patient group size, first from the perspective of the decision-maker (approach A), and second from the perspective of the industry (approach B). To put clinical outcome measures into relation to one another, minimum clinically important differences (MCIDs) were derived from the literature and compared. RESULTS The annual treatment costs of newly authorized drugs were substantially higher (both pre- and post-negotiation) than that of their comparators (e.g., psoriasis, pre-negotiation: €20,601.59, post-negotiation: €16,763.57; comparators: €5178.00). However, although newly launched drugs were more expensive than their comparators, they brought greater medical benefits and were more aligned with value (r = 0.59, P < 0.001) than older drugs. We estimated WTP to vary widely by indication group [€33,814.08 per 1 percentage point hemoglobin A1c (HbA1c) reduction for diabetes, €10,970.83 per life year gained for cardiovascular disease, and €663.46 per 1% PASI decrease for psoriasis; approach A]. WTP was converted to MCID thresholds: diabetes: €16,907.04; cardiovascular drugs: no MCID existent to convert; and psoriasis: €33,173.00. WTP remained constant over time for diabetes and cardiovascular drugs but increased for psoriasis drugs. CONCLUSION This paper is one of the first to estimate the implicit WTP for prescription pharmaceuticals post-AMNOG and suggests that the WTP may vary between different therapeutic areas. Additionally, making different assumptions (approach A versus approach B) with regard to the assumed effectiveness in indication areas that had been declared as having no additional benefit by the FJC may explain the different perspectives of decision-makers and of the pharmaceutical industry on the value of a pharmaceutical.
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Affiliation(s)
- Melanie Büssgen
- Hamburg Center for Health Economics, University of Hamburg, Esplanade 36, 20354, Hamburg, Germany.
| | - Tom Stargardt
- Hamburg Center for Health Economics, University of Hamburg, Esplanade 36, 20354, Hamburg, Germany
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13
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Wamil M, Hassaine A, Rao S, Li Y, Mamouei M, Canoy D, Nazarzadeh M, Bidel Z, Copland E, Rahimi K, Salimi-Khorshidi G. Stratification of diabetes in the context of comorbidities, using representation learning and topological data analysis. Sci Rep 2023; 13:11478. [PMID: 37455284 PMCID: PMC10350454 DOI: 10.1038/s41598-023-38251-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2022] [Accepted: 07/05/2023] [Indexed: 07/18/2023] Open
Abstract
Diabetes is a heterogenous, multimorbid disorder with a large variation in manifestations, trajectories, and outcomes. The aim of this study is to validate a novel machine learning method for the phenotyping of diabetes in the context of comorbidities. Data from 9967 multimorbid patients with a new diagnosis of diabetes were extracted from Clinical Practice Research Datalink. First, using BEHRT (a transformer-based deep learning architecture), the embeddings corresponding to diabetes were learned. Next, topological data analysis (TDA) was carried out to test how different areas in high-dimensional manifold correspond to different risk profiles. The following endpoints were considered when profiling risk trajectories: major adverse cardiovascular events (MACE), coronary artery disease (CAD), stroke (CVA), heart failure (HF), renal failure (RF), diabetic neuropathy, peripheral arterial disease, reduced visual acuity and all-cause mortality. Kaplan Meier curves were plotted for each derived phenotype. Finally, we tested the performance of an established risk prediction model (QRISK) by adding TDA-derived features. We identified four subgroups of patients with diabetes and divergent comorbidity patterns differing in their risk of future cardiovascular, renal, and other microvascular outcomes. Phenotype 1 (young with chronic inflammatory conditions) and phenotype 2 (young with CAD) included relatively younger patients with diabetes compared to phenotypes 3 (older with hypertension and renal disease) and 4 (older with previous CVA), and those subgroups had a higher frequency of pre-existing cardio-renal diseases. Within ten years of follow-up, 2592 patients (26%) experienced MACE, 2515 patients (25%) died, and 2020 patients (20%) suffered RF. QRISK3 model's AUC was augmented from 67.26% (CI 67.25-67.28%) to 67.67% (CI 67.66-67.69%) by adding specific TDA-derived phenotype and the distances to both extremities of the TDA graph improving its performance in the prediction of CV outcomes. We confirmed the importance of accounting for multimorbidity when risk stratifying heterogenous cohort of patients with new diagnosis of diabetes. Our unsupervised machine learning method improved the prediction of clinical outcomes.
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Affiliation(s)
- Malgorzata Wamil
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK.
- Mayo Clinic Healthcare, 15 Portland Place, London, UK.
| | - Abdelaali Hassaine
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Shishir Rao
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Yikuan Li
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Mohammad Mamouei
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Dexter Canoy
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Milad Nazarzadeh
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Zeinab Bidel
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Emma Copland
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Kazem Rahimi
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
| | - Gholamreza Salimi-Khorshidi
- Deep Medicine, Oxford Martin School, University of Oxford, Oxford, UK
- Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, UK
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14
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Mukherjee P, RoyChaudhuri S, Majumder A. COVID-19 and Pre-existing Type 2 Diabetes Mellitus: A Retrospective Observational Study From Eastern India on the Association Between Glycaemic Control and Treatment Outcomes. Cureus 2023; 15:e35165. [PMID: 36960253 PMCID: PMC10030157 DOI: 10.7759/cureus.35165] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/18/2023] [Indexed: 02/21/2023] Open
Abstract
BACKGROUND Diabetes has emerged as an important risk factor for causing severe illness and death from COVID-19. There is a paucity of structured data from the Indian subcontinent on the impact that glycaemic control (both immediate and remote) has on the degree of required medical intervention and mortality among hospitalized COVID-19 patients with type 2 diabetes mellitus (T2DM). OBJECTIVES To evaluate the differences in clinical characteristics and treatment outcomes between well-controlled and poorly controlled patients with T2DM and COVID-19. METHODS This was a retrospective observational study. Data on 177 patients who were hospitalized between February 2021 and July 2021 were categorized into four groups using a cut-off admission plasma glucose of <200 mg/dL and glycated hemoglobin (HbA1c) <7.5%. RESULTS Patients with poorly controlled diabetes presented at a significantly older age than the other groups. Radiological findings suggested severe lung involvement in them. As a combined group patients with HbA1c ≥7.5% required more ventilatory requirement as compared with the group having HbA1c <7.5% irrespective of admission glucose. They also required prolonged hospitalization and intensive care unit (ICU) stays as compared with the well-controlled diabetes group. In this study, within similar ranges of HbA1c admission glucose seemed to have a numerical impact on mortality without being able to achieve statistical significance. CONCLUSION From the current study, it can be concluded that poor glycaemic control, particularly HbA1c ≥7.5%, is an important risk factor for the development of severe COVID-19 and a predictor for the requirement of more intensive treatment and adverse treatment outcomes leading to increased hospital and ICU stay.
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Affiliation(s)
- Poulomi Mukherjee
- Community Medicine, Kolkata Medical College & Hospital, Kolkata, IND
| | | | - Anirban Majumder
- Endocrinology, Kali Prasad Chowdhury Medical College & Hospital, Kolkata, IND
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15
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Ragia G, Atzemian N, Maslarinou A, Manolopoulos VG. SLCO1B1 c.521T>C gene polymorphism decreases hypoglycemia risk in sulfonylurea-treated type 2 diabetic patients. Drug Metab Pers Ther 2022; 37:347-352. [PMID: 36169244 DOI: 10.1515/dmpt-2022-0131] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2022] [Accepted: 08/02/2022] [Indexed: 12/13/2022]
Abstract
OBJECTIVES Pharmacogenomics can explain some of the heterogeneity of sulfonylurea (SU)-related hypoglycemia risk. Recently, a role of OATP1B1, encoded by SLCO1B1 gene, on SU liver transport prior of metabolism has been uncovered. The aim of the present study was to explore the potential association of SLCO1B1 c.521T>C polymorphism, leading to reduced OATP1B1 function, with SU-related hypoglycemia risk. METHODS Study cohort consists of 176 type 2 diabetes patients treated with the SUs glimepiride or gliclazide. 92 patients reported SU-related hypoglycemia, while 84 patients had never experienced a hypoglycemic event. Patients were previously genotyped for CYP2C9 *2 and *3 variant alleles that lead to decreased enzyme activity of the SU metabolizing enzyme CYP2C9 and have been associated with increased SU-related hypoglycemia risk. SLCO1B1 c.521T>C polymorphism was genotyped by use of PCR-RFLP analysis. RESULTS SLCO1B1 c.521TC genotype frequency was significantly lower in hypoglycemic cases than non-hypoglycemic controls (15.2% vs. 32.1%, p=0.008). In an adjusted model, c.521TC genotype significantly reduced the risk of hypoglycemia (OR 0.371; 95% C.I. 0.167-0.822; p=0.015). In CYP2C9 intermediate metabolizers (n=54) c.521TC genotype frequency was significantly decreased in cases compared to controls (3 out of 36 cases, 8.3% vs. 7 out of 18 controls, 38.9%, p=0.012). A similar albeit not significant difference of SLCO1B1 c.521TC genotype was present in CYP2C9 extensive metabolizers (n=120) (18.2% in cases vs. 30.8% in controls, p=0.113). CONCLUSIONS We have found a protective effect of SLCO1B1 c.521C variant on SU-related hypoglycemia risk both independently and in interaction with CYP2C9 phenotypes. Our results suggest a possible linkage of SLCO1B1 c.521T>C polymorphism with variants in other genes impairing OATPs expressed in pancreatic islets that could interfere with SU tissue distribution.
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Affiliation(s)
- Georgia Ragia
- Laboratory of Pharmacology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.,Individualised Medicine & Pharmacological Research Solutions Center (IMPReS), Alexandroupolis, Greece
| | - Natalia Atzemian
- Laboratory of Pharmacology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.,Individualised Medicine & Pharmacological Research Solutions Center (IMPReS), Alexandroupolis, Greece
| | - Anthi Maslarinou
- Laboratory of Pharmacology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.,Individualised Medicine & Pharmacological Research Solutions Center (IMPReS), Alexandroupolis, Greece
| | - Vangelis G Manolopoulos
- Laboratory of Pharmacology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.,Individualised Medicine & Pharmacological Research Solutions Center (IMPReS), Alexandroupolis, Greece.,Clinical Pharmacology Unit, Academic General Hospital of Alexandroupolis, Alexandroupolis, Greece
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16
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Lee KA, Kim DJ, Han K, Chon S, Moon MK, on Behalf of the Committee of Clinical Practice Guideline of Korean Diabetes Association. Screening for Prediabetes and Diabetes in Korean Nonpregnant Adults: A Position Statement of the Korean Diabetes Association, 2022. Diabetes Metab J 2022; 46:819-826. [PMID: 36455530 PMCID: PMC9723194 DOI: 10.4093/dmj.2022.0364] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/18/2022] [Accepted: 11/13/2022] [Indexed: 11/25/2022] Open
Abstract
Diabetes screening serves to identify individuals at high-risk for diabetes who have not yet developed symptoms and to diagnose diabetes at an early stage. Globally, the prevalence of diabetes is rapidly increasing. Furthermore, obesity and/or abdominal obesity, which are major risk factors for type 2 diabetes mellitus (T2DM), are progressively increasing, particularly among young adults. Many patients with T2DM are asymptomatic and can accompany various complications at the time of diagnosis, as well as chronic complications develop as the duration of diabetes increases. Thus, proper screening and early diagnosis are essential for diabetes care. Based on reports on the changing epidemiology of diabetes and obesity in Korea, as well as growing evidence from new national cohort studies on diabetes screening, the Korean Diabetes Association has updated its clinical practice recommendations regarding T2DM screening. Diabetes screening is now recommended in adults aged ≥35 years regardless of the presence of risk factors, and in all adults (aged ≥19) with any of the risk factors. Abdominal obesity based on waist circumference (men ≥90 cm, women ≥85 cm) was added to the list of risk factors.
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Affiliation(s)
- Kyung Ae Lee
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Clinical Medicine of Jeonbuk National UniversityBiomedical Research Institute of Jeonbuk National University Hosital, Jeonbuk National University Medical School, Jeonju, Korea
| | - Dae Jung Kim
- Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea
| | - Kyungdo Han
- Department of Statistics and Actuarial Science, Soongsil University, Seoul, Korea
| | - Suk Chon
- Department of Endocrinology and Metabolism, Kyung Hee University Medical Center, College of Medicine, Kyung Hee University, Seoul, Korea
| | - Min Kyong Moon
- Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea
| | - on Behalf of the Committee of Clinical Practice Guideline of Korean Diabetes Association
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Clinical Medicine of Jeonbuk National UniversityBiomedical Research Institute of Jeonbuk National University Hosital, Jeonbuk National University Medical School, Jeonju, Korea
- Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea
- Department of Statistics and Actuarial Science, Soongsil University, Seoul, Korea
- Department of Endocrinology and Metabolism, Kyung Hee University Medical Center, College of Medicine, Kyung Hee University, Seoul, Korea
- Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea
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17
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Mittal M, Jethwani P, Naik D, Garg MK. Non-medicalization of medical science: Rationalization for future. World J Methodol 2022; 12:402-413. [PMID: 36186743 PMCID: PMC9516546 DOI: 10.5662/wjm.v12.i5.402] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/20/2022] [Revised: 06/13/2022] [Accepted: 07/22/2022] [Indexed: 02/08/2023] Open
Abstract
As we delve into the intricacies of human disease, millions of people continue to be diagnosed as having what are labelled as pre-conditions or sub-clinical entities and may receive treatments designed to prevent further progression to clinical disease, but with debatable impact and consequences. Endocrinology is no different, with almost every organ system and associated diseases having subclinical entities. Although the expansion of these “grey” pre-conditions and their treatments come with a better understanding of pathophysiologic processes, they also entail financial costs and drug adverse-effects, and lack true prevention, thus refuting the very foundation of Medicine laid by Hippocrates “Primum non nocere” (Latin), i.e., do no harm. Subclinical hypothyroidism, prediabetes, osteopenia, and minimal autonomous cortisol excess are some of the endocrine pre-clinical conditions which do not require active pharmacological management in the vast majority. In fact, progression to clinical disease is seen in only a small minority with reversal to normality in most. Giving drugs also does not lead to true prevention by changing the course of future disease. The goal of the medical fraternity thus as a whole should be to bring this large chunk of humanity out of the hospitals towards leading a healthy lifestyle and away from the label of a medical disease condition.
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Affiliation(s)
- Madhukar Mittal
- Department of Endocrinology and Metabolism, All India Institute of Medical Sciences Jodhpur, Jodhpur 342005, India
| | - Parth Jethwani
- Department of Endocrinology and Metabolism, All India Institute of Medical Sciences Jodhpur, Jodhpur 342005, India
| | - Dukhabandhu Naik
- Department of Endocrinology and Metabolism, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006, India
| | - MK Garg
- Department of Endocrinology and Metabolism, All India Institute of Medical Sciences Jodhpur, Jodhpur 342005, India
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18
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McCann M, O'Brien A, Larbalestier R, Davis T. Sodium-glucose cotransport-2 inhibitor induced ketoacidosis following coronary artery bypass surgery: implications for management. Intern Med J 2022; 52:876-879. [PMID: 35538006 DOI: 10.1111/imj.15772] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2021] [Revised: 12/15/2021] [Accepted: 12/15/2021] [Indexed: 11/29/2022]
Abstract
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) improve cardiovascular outcomes in patients with type 2 diabetes (T2D). Diabetic ketoacidosis (DKA) is an uncommon, but well recognised, life-threatening complication of SGLT2i. In a retrospective study of patients with T2D undergoing cardiac surgery at our institution, DKA occurred in 15.3% of patients taking SGLT2i at the time of surgery, compared with 0.47% of non-SGLT2i-treated patients. Intravenous insulin in the first 24 h after surgery was associated with a significantly lower risk of DKA in SGLT2i patients. Use of an insulin infusion should be considered in these patients, especially in those who are unable to cease their SGLT2i pre-operatively.
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Affiliation(s)
- Michael McCann
- Department of Cardiology, Fiona Stanley Hospital, Perth, Western Australia, Australia
| | - Aoife O'Brien
- Department of General Medicine and Endocrinology, Fremantle Hospital, Perth, Western Australia, Australia
| | - Robert Larbalestier
- Department of Cardiothoracic Surgery and Transplantation, Fiona Stanley Hospital, Perth, Western Australia, Australia
| | - Tim Davis
- Department of General Medicine and Endocrinology, Fremantle Hospital, Perth, Western Australia, Australia.,School of Medicine, University of Western Australia, Perth, Western Australia, Australia
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Ruiz-García A, Pallarés-Carratalá V, Serrano-Cumplido A, Escobar-Cervantes C, Barquilla-García A, Divisón-Garrote JA, Turégano-Yedro M, Prieto-Díaz MA, Cinza-Sanjurjo S, Alonso-Moreno FJ, Beato-Fernández P, García-Matarín L, Rey-Aldana D, Martín-Rioboó E, Moyá-Amengual A, Crespo-Sabarís R, Piera-Carbonell A, Romero-Vigara JC, Carrasco-Carrasco E, Velilla-Zancada S, Seoane-Vicente MC, Górriz-Teruel JL, Polo-García J, Barrios V. Evaluation of prophylaxis in primary prevention with acetylsalicylic acid in people with diabetes: A scoping review. Semergen 2022; 48:275-292. [PMID: 35181226 DOI: 10.1016/j.semerg.2021.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2021] [Revised: 11/07/2021] [Accepted: 12/03/2021] [Indexed: 11/17/2022]
Abstract
BACKGROUND The efficacy and safety of acetylsalicylic acid (ASA) prophylaxis for the primary prevention of atherosclerotic cardiovascular disease (ACVD) remain controversial in people with diabetes (DM) without ACVD, because the possible increased risk of major bleeding could outweigh the potential reduction in the risk of mortality and of major adverse cardiovascular events (MACE) considered individually or together. OBJECTIVE To evaluate the overall risk-benefit of ASA prophylaxis in primary prevention in people with DM and to compare the recommendations of the guidelines with the results of the meta-analyses (MA) and systematic reviews (SR). MATERIAL AND METHODS We searched Medline, Google Scholar, Embase, and the Cochrane Library for SR and MA published from 2009 to 2020 which compared the effects of ASA prophylaxis versus placebo or control followed up for at least one year in people with DM without ACVD. Heterogeneity among the randomized clinical trials (RCT) included in the SR and MA was assessed. Cardiovascular outcomes of efficacy (all-cause mortality [ACM], cardiovascular mortality [CVM], myocardial infarction [MI], stroke and MACE) and of safety (major bleeding events [MBE], major gastrointestinal bleeding events [MGIBE], and intracranial and extracranial bleeding) were shown. RESULTS The recommendations of 12 guidelines were evaluated. The results of 25 SR and MA that included a total of 20 RCT were assessed. None of the MA or SR showed that ASA prophylaxis decreased the risk of ACM, CVM or MI. Only two of the 19 SR and MA that evaluated ischemic stroke showed a decrease in the stroke risk (mean 20.0% [SD±5.7]), bordering on statistical significance. Almost half of the MA and SR showed, bordering on statistical significance, a risk reduction for the MACE composite endpoint (mean 10.5% [SD±3.3]). The significant increases in MGIBE risk ranged from 35% to 55%. The significant increases in the risk of MBE and extracraneal bleeding were 33.4% (SD±14.9) and 54.5% (SD±0.7) respectively. CONCLUSION The overall risk-benefit assessment of ASA prophylaxis in primary prevention suggests that it should not be applied in people with DM.
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Affiliation(s)
- A Ruiz-García
- Family Medicine, Pinto University Health Center, Pinto, Madrid, Spain; European University of Madrid, Villaviciosa de Odón, Madrid, Spain
| | - V Pallarés-Carratalá
- Family Medicine, Health Surveillance Unit, Mutual Insurance Union, Castellón, Spain; Medicine Department, Jaume I University, Castellón, Spain.
| | | | | | - A Barquilla-García
- Family Medicine, Trujillo Primary Care Team, Clinics of Herguijuela and Conquista de la Sierra), Cáceres, Spain
| | - J A Divisón-Garrote
- Family Medicine, Casas Ibáñez Health Center, Fuentealbilla Clinic, Albacete, Spain
| | | | - M A Prieto-Díaz
- Family Medicine, Vallobín - La Florida Health Center, Oviedo, Spain
| | - S Cinza-Sanjurjo
- Family Medicine, Porto do Son Health Center, Santiago de Compostela Health Area, Santiago de Compostela, Spain; Center for Biomedical Research Network on Cardiovascular Diseases (CIBERCV), Madrid, Spain
| | | | - P Beato-Fernández
- Family Medicine, Premia de Mar Primary Care Center, Catalan Institute of Health, Barcelona, Spain
| | - L García-Matarín
- Family Medicine, Aguadulce Sur Health Center, Roquetas de Mar, Almería, Spain
| | - D Rey-Aldana
- Family Medicine, Estrada Health Center, Pontevedra, Spain; USC-SEMERGEN Chair, University of Santiago de Compostela, Santiago de Compostela, Spain
| | - E Martín-Rioboó
- Family Medicine, Maimónides Institute for Biomedical Research of Córdoba (IMIBIC), Reina Sofía Hospital, Poniente clinical management unit, Córdoba, Spain
| | - A Moyá-Amengual
- Occupational Medicine, Santa Catalina Health Center, Palma de Mallorca, Islas Baleares, Spain
| | - R Crespo-Sabarís
- Family Medicine, Primary Care Management of La Rioja Health Service, Logroño, La Rioja, Spain
| | | | | | | | | | | | - J L Górriz-Teruel
- Nephrology Service, University Clinical Hospital, Valencia, Spain; School of Medicine, University of Valencia, Valencia, Spain
| | - J Polo-García
- Family Medicine, Casar de Cáceres Health Center, Cáceres, Spain
| | - V Barrios
- Cardiology Service, Ramón y Cajal University Hospital, Madrid, Spain; University of Alcalá, Madrid, Spain
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Chivese T, Hirst J, Matizanadzo JT, Custodio M, Farmer A, Norris S, Levitt N. The diagnostic accuracy of HbA 1c , compared to the oral glucose tolerance test, for screening for type 2 diabetes mellitus in Africa-A systematic review and meta-analysis. Diabet Med 2022; 39:e14754. [PMID: 34854127 DOI: 10.1111/dme.14754] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2021] [Accepted: 11/29/2021] [Indexed: 01/16/2023]
Abstract
OBJECTIVE To assess the diagnostic accuracy of glycated haemoglobin A1c (HbA1c ), compared to fasting plasma glucose (FPG) and the oral glucose tolerance test (OGTT), in screening for type 2 diabetes (T2D) in Africa. METHODS We systematically searched databases for studies that compared the HbA1c to either the OGTT, or the FPG for T2D diagnosis were included. The QUADAS 2 tool was used for assessing the quality of included studies. We used the split component synthesis (SCS) method for the meta-analysis of diagnostic accuracy studies to pool the studies for meta-analysis of sensitivity and specificity, primarily at the HbA1c ≥48 mmol/mol (6.5%) cut-off and at other cut-offs. We assessed heterogeneity using the I2 statistic and publication bias using Doi plots. RESULTS Eleven studies, from seven African countries, with 12,925 participants, were included. Against the OGTT, HbA1c ≥48 mmol/mol (6.5%) had a pooled sensitivity of 57.7% (95% confidence interval [CI] 43.4-70.9) and specificity of 92.3% (95% CI 83.9-96.5). Against the FPG, HbA1c ≥48 mmol/mol (6.5%) had a pooled sensitivity of 64.5% (95% CI 50.5-76.4) and specificity of 94.3% (95% CI 87.9-97.5). The highest sensitivity for HbA1c , against the OGTT, was at the 42 mmol/mol (6.0%) cut-off. CONCLUSION In Africa, the HbA1c ≥48 mmol/mol (6.5%) cut-off may miss almost half of the individuals with T2D based on blood glucose measures.
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Affiliation(s)
- Tawanda Chivese
- Department of Population Medicine, College of Medicine, QU Health, Qatar University, Doha, Qatar
| | - Jennifer Hirst
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Joshua T Matizanadzo
- Department of Public Health and Primary Care, Brighton & Sussex Medical School, Brighton, UK
| | - Michael Custodio
- Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
| | - Andrew Farmer
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Shane Norris
- SAMRC/Wits Developmental Pathways for Health Research Unit, Department of Paediatrics, Faculty of Medicine and Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
| | - Naomi Levitt
- Chronic Disease Initiative for Africa, Department of Medicine, Faculty of Medicine and Health Sciences, University of Cape Town, Cape Town, South Africa
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Doni K, Bühn S, Weise A, Mann NK, Hess S, Sönnichsen A, Pieper D, Thürmann P, Mathes T. Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Ther Adv Drug Saf 2022; 13:20420986211072383. [PMID: 35111291 PMCID: PMC8785305 DOI: 10.1177/20420986211072383] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2021] [Accepted: 12/14/2021] [Indexed: 11/17/2022] Open
Abstract
Registration: PROSPERO: CRD42020210645 Introduction: We aimed to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older patients with type 2 diabetes with inadequate glycaemic control. Methods: We included randomized controlled trials (RCTs) in older (⩾65 years) patients with type 2 diabetes. The intervention group was randomized to treatment with any DPP-4 inhibitors. A systematic search in MEDLINE and Embase was performed in December 2020. For assessing the risk of bias, RoB 2 tool was applied. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We pooled outcomes using random effects meta-analyses. Results: We identified 16 RCTs that included 19,317 patients with a mean age of greater than 70 years. The mean HbA1c level ranged between 7.1 and 10.0 g/dl. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly [risk ratio (RR) 1.04; 95% confidence interval (CI) 0.89–1.21]. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia (RR 1.08; 95% CI 1.01–1.16), but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas (RR 0.88; 95% CI 0.75–1.04). DPP-4 inhibitors probably reduce the risk for hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case second-line treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas. Plain language summary Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes Introduction: We performed the review to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older type 2 diabetes patients with blood sugar outside the normal level. Methods: To answer the question, we searched various electronic databases. We included studies in older (⩾65 years) patients with type 2 diabetes that assessed the safety of DPP-4 inhibitors. The data from the different studies were quantitatively summarized using statistical methods. We assessed the quality of the data to judge the certainty of the findings. Results: We identified 16 studies that included 19,317 patients with a mean age greater than 70 years. The average blood sugar level of patients in the included studies was slightly or moderately increased. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia, but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas. DPP-4s probably reduce the risk of hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase the risk that blood sugar falls below normal. Adding DPP-4 inhibitorss to standard care in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case additional treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas.
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Affiliation(s)
- Katharina Doni
- Institute for Research in Operative Medicine, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
- Institute for Health Economics and Clinical Epidemiology, University of Cologne, Cologne, Germany
| | - Stefanie Bühn
- Institute for Research in Operative Medicine, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
| | - Alina Weise
- Institute for Research in Operative Medicine, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
| | - Nina-Kristin Mann
- Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
| | - Simone Hess
- Institute for Research in Operative Medicine, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
| | - Andreas Sönnichsen
- Department of General Practice and Family Medicine, Center for Public Health, Medical University of Vienna, Vienna, Austria
| | - Dawid Pieper
- Institute for Research in Operative Medicine, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
- Center for Health Services Research, Brandenburg Medical School Theodor Fontane, Rüdersdorf, Germany
- Faculty of Health Sciences Brandenburg, Institute for Health Services and Health System Research, Brandenburg Medical School Theodor Fontane, Rüdersdorf, Germany
| | - Petra Thürmann
- Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
- Philipp Klee-Institute for Clinical Pharmacology, Helios University Hospital Wuppertal, Wuppertal, Germany
| | - Tim Mathes
- Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Heusnerstraße 40, 42283 Wuppertal Germany
- Institute for Medical Statistics, University Medical Center Göttingen, Göttingen, Germany
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Li Y, Wu Y, Shu Y, Li S, Pei J, Chen H, Liu S, Xiang G, Wang W, Shan P, Su H, Wu X, Yan D, Li W. Blood glucose may be another index to initiate insulin treatment besides glycated hemoglobin A1c after oral antidiabetic medications failure for glycemic control: A real-world survey. Front Endocrinol (Lausanne) 2022; 13:998210. [PMID: 36506049 PMCID: PMC9729526 DOI: 10.3389/fendo.2022.998210] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2022] [Accepted: 11/08/2022] [Indexed: 11/27/2022] Open
Abstract
OBJECTIVE The inertia of insulin initiation is a barrier to achieving glycemic control when oral antidiabetic drugs fail to control glucose during the treatment of type 2 diabetes (T2D). Insulin initiation is usually based on glycated hemoglobin A1c (A1C). To investigate whether there is another index for insulin initiation besides A1C, we conducted a cross-sectional survey in the real world. METHODS We conducted a multicenter cross-section survey with a total of 1034 T2D patients. All patients, at the time of the survey, decided to initiate insulin therapy due to failure of controlling glucose using only oral antidiabetic drugs. We analyzed the differences of blood glucose between patients who were tested for A1C and those who were not. RESULTS 666 (64.4%) patients were tested A1C and 368 (35.6%) were not. Neither fasting blood glucose (FBG) (12.0 ± 2.9 vs 12.3 ± 2.9 mmol/L, t = 1.494, P = 0.135) nor postprandial blood glucose (PBG) (18.4 ± 4.8 vs 17.9 ± 4.8 mmol/L, t = 1.315, P = 0.189) were significantly different between patients with and without A1C. CONCLUSION Our results demonstrated that initiating insulin based on FBG or PBG is a common clinical practice, at least in China; moreover, since it is easier to obtain than A1C, it can be a simple and effective way to overcome clinical inertia for initiating insulin.
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Affiliation(s)
- Yanli Li
- Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
| | - Yan Wu
- Department of Endocrinology, Shenzhen People’s Hospital, Shenzhen, China
| | - Yi Shu
- Department of Endocrinology, The Sixth Affiliated Hospital of South China University of Technology, Foshan, China
| | - Shu Li
- Department of Endocrinology, Huizhou Municipal Central Hospital, Huizhou, China
| | - Jianhao Pei
- Department of Endocrinology, Guangdong Provincial People’s Hospital, Guangzhou, China
| | - Hong Chen
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
| | - Shiping Liu
- Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China
| | - Guangda Xiang
- Department of Endocrinology, General Hospital of Central Theater Command, Wuhan, China
| | - Wenbo Wang
- Department of Endocrinology, Peking University Shougang Hospital, Beijing, China
| | - Pengfei Shan
- Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China
| | - Heng Su
- Department of Endocrinology, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, China
| | - Xiaoyan Wu
- Department of Endocrinology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China
| | - Dewen Yan
- Department of Endocrinology, The First Affiliated Hospital of Shenzhen University, Shenzhen, China
- *Correspondence: Wangen Li, ; Dewen Yan,
| | - Wangen Li
- Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
- *Correspondence: Wangen Li, ; Dewen Yan,
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Nabrdalik K, Skonieczna-Żydecka K, Irlik K, Hendel M, Kwiendacz H, Łoniewski I, Januszkiewicz K, Gumprecht J, Lip GYH. Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus: A systematic review, meta-analysis and meta-regression of randomized controlled trials. Front Endocrinol (Lausanne) 2022; 13:975912. [PMID: 36187122 PMCID: PMC9524196 DOI: 10.3389/fendo.2022.975912] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/29/2022] [Accepted: 08/16/2022] [Indexed: 01/10/2023] Open
Abstract
INTRODUCTION Metformin is the first choice drug in the treatment of type 2 diabetes mellitus but its administration may be linked to gastrointestinal adverse events limiting its use. OBJECTIVES The objective of this systematic review and meta-analysis was to assess the risk of gastrointestinal adverse events related to metformin use in patients with type 2 diabetes treated with metformin. METHODS PUB MED/CINAHL/Web of Science/Scopus were searched from database inception until 08.11.2020 for articles in English and randomized controlled trials related to patients with type 2 diabetes treated with metformin were included. RESULTS From 5315 publications, we identified 199 potentially eligible full-text articles. Finally, 71 randomized controlled trials were included in the meta-analysis. In these studies, metformin use was associated with higher risk of abdominal pain, diarrhea and nausea comparing to control. The risks of abdominal pain and nausea were highest comparing to placebo. Bloating risk was only elevated when metformin treatment was compared to DPP4i. CONCLUSIONS The risk of gastrointestinal adverse events such as abdominal pain, nausea and diarrhea is higher in type 2 diabetes patients treated with metformin compared to other antidiabetic drugs. There is a higher risk of bloating and diarrhea with metformin immediate-release than with metformin extended release formulation. SYSTEMATIC REVIEW REGISTRATION https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021289975, identifier CRD42021289975.
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Affiliation(s)
- Katarzyna Nabrdalik
- Department of Internal Medicine, Diabetology and Nephrology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
- Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
| | - Karolina Skonieczna-Żydecka
- Department of Biochemical Science, Pomeranian Medical University, Szczecin, Poland
- *Correspondence: Karolina Skonieczna-Żydecka,
| | - Krzysztof Irlik
- Students’ Scientific Association by the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
| | - Mirela Hendel
- Students’ Scientific Association by the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
| | - Hanna Kwiendacz
- Department of Internal Medicine, Diabetology and Nephrology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
| | - Igor Łoniewski
- Department of Biochemical Science, Pomeranian Medical University, Szczecin, Poland
| | | | - Janusz Gumprecht
- Department of Internal Medicine, Diabetology and Nephrology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland
| | - Gregory Y. H. Lip
- Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
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Saboo B, Seshadri K, Agarwal S, Sahay R, Ghosh S, Joshi S. RSSDI guidelines on thyroid dysfunction and diabetes. Int J Diabetes Dev Ctries 2021. [DOI: 10.1007/s13410-021-01030-7] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
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25
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Schouten RM, Bueno MLP, Duivesteijn W, Pechenizkiy M. Mining sequences with exceptional transition behaviour of varying order using quality measures based on information-theoretic scoring functions. Data Min Knowl Discov 2021. [DOI: 10.1007/s10618-021-00808-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
AbstractDiscrete Markov chains are frequently used to analyse transition behaviour in sequential data. Here, the transition probabilities can be estimated using varying order Markov chains, where order k specifies the length of the sequence history that is used to model these probabilities. Generally, such a model is fitted to the entire dataset, but in practice it is likely that some heterogeneity in the data exists and that some sequences would be better modelled with alternative parameter values, or with a Markov chain of a different order. We use the framework of Exceptional Model Mining (EMM) to discover these exceptionally behaving sequences. In particular, we propose an EMM model class that allows for discovering subgroups with transition behaviour of varying order. To that end, we propose three new quality measures based on information-theoretic scoring functions. Our findings from controlled experiments show that all three quality measures find exceptional transition behaviour of varying order and are reasonably sensitive. The quality measure based on Akaike’s Information Criterion is most robust for the number of observations. We furthermore add to existing work by seeking for subgroups of sequences, as opposite to subgroups of transitions. Since we use sequence-level descriptive attributes, we form subgroups of entire sequences, which is practically relevant in situations where you want to identify the originators of exceptional sequences, such as patients. We show this relevance by analysing sequences of blood glucose values of adult persons with diabetes type 2. In the experiments, we find subgroups of patients based on age and glycated haemoglobin (HbA1c), a measure known to correlate with average blood glucose values. Clinicians and domain experts confirmed the transition behaviour as estimated by the fitted Markov chain models.
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26
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Chudasama YV, Zaccardi F, Coles B, Gillies CL, Hvid C, Seidu S, Davies MJ, Khunti K. Ethnic, social and multimorbidity disparities in therapeutic inertia: A UK primary care observational study in patients newly diagnosed with type 2 diabetes. Diabetes Obes Metab 2021; 23:2437-2445. [PMID: 34189827 DOI: 10.1111/dom.14482] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2021] [Revised: 06/23/2021] [Accepted: 06/27/2021] [Indexed: 01/16/2023]
Abstract
AIM To investigate factors associated with delays in receiving glucose-lowering therapy in patients newly diagnosed with type 2 diabetes mellitus (T2DM), and explore the preferential order and time of intensifications. MATERIALS AND METHODS Retrospective cohort study including 120 409 adults with T2DM initiating first- to fourth-line glucose-lowering therapy in primary care between 2000 and 2018, using the UK Clinical Practice Research Datalink linked to Hospital Episode Statistics, Office of National Statistics death registration, and 2007 Index of Multiple Deprivation data. Associations were investigated using time-to-event analysis. RESULTS The longest delays to prescription of first-line therapy were observed in older patients, of black or other ethnicities, and with multimorbidity. People from the most deprived areas received earlier first-line treatment than those from the least deprived areas. The majority were treated with metformin (82.4%) as the first-line prescription, sulphonylurea (50.4%) as second-line, dipeptidyl peptidase-4 inhibitor (27.7%) as third-line, and insulin (28.0%) as fourth-line. In the past 5 years, there was an increase in prescriptions of dipeptidyl peptidase-4-inhibitor and sodium-glucose transport protein-2 inhibitor. The median time was 0.5 years for first-line prescription, 4.1 for second-line, 4.6 for third-line and 4.7 for fourth-line. After T2DM diagnosis, 25% of patients developed cardiovascular disease and non-cardiovascular disease complications within a median time of 12-14 years, and received intensification 5-6 years later. CONCLUSIONS Within the complex challenges of managing blood glucose levels and risk of additional comorbidities, future health care research and guidelines should focus on overcoming therapeutic inertia particularly at an earlier stage for older patients, from ethnic minorities and with multimorbidities.
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Affiliation(s)
- Yogini V Chudasama
- Leicester Real World Evidence Unit, Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK
| | - Francesco Zaccardi
- Leicester Real World Evidence Unit, Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK
| | - Briana Coles
- Leicester Real World Evidence Unit, Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK
| | - Clare L Gillies
- Leicester Real World Evidence Unit, Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK
| | - Christian Hvid
- Novo Nordisk Region Europe Pharmaceuticals A/S, Københav, Denmark
| | - Samuel Seidu
- Leicester Real World Evidence Unit, Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK
| | - Melanie J Davies
- NIHR Leicester Biomedical Research Centre, Leicester Diabetes Centre, Leicester, UK
| | - Kamlesh Khunti
- Leicester Real World Evidence Unit, Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK
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Niwaha AJ, Rodgers LR, Greiner R, Balungi PA, Mwebaze R, McDonald TJ, Hattersley AT, Shields BM, Nyirenda MJ, Jones AG. HbA1c performs well in monitoring glucose control even in populations with high prevalence of medical conditions that may alter its reliability: the OPTIMAL observational multicenter study. BMJ Open Diabetes Res Care 2021; 9:9/1/e002350. [PMID: 34535465 PMCID: PMC8451306 DOI: 10.1136/bmjdrc-2021-002350] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2021] [Accepted: 08/22/2021] [Indexed: 11/03/2022] Open
Abstract
INTRODUCTION The utility of HbA1c (glycosylated hemoglobin) to estimate glycemic control in populations of African and other low-resource countries has been questioned because of high prevalence of other medical conditions that may affect its reliability. Using continuous glucose monitoring (CGM), we aimed to determine the comparative performance of HbA1c, fasting plasma glucose (FPG) (within 5 hours of a meal) and random non-fasting glucose (RPG) in assessing glycemic burden. RESEARCH DESIGN AND METHODS We assessed the performance of HbA1c, FPG and RPG in comparison to CGM mean glucose in 192 Ugandan participants with type 2 diabetes. Analysis was undertaken in all participants, and in subgroups with and without medical conditions reported to affect HbA1c reliability. We then assessed the performance of FPG and RPG, and optimal thresholds, in comparison to HbA1c in participants without medical conditions thought to alter HbA1c reliability. RESULTS 32.8% (63/192) of participants had medical conditions that may affect HbA1c reliability: anemia 9.4% (18/192), sickle cell trait and/or hemoglobin C (HbC) 22.4% (43/192), or renal impairment 6.3% (12/192). Despite high prevalence of medical conditions thought to affect HbA1c reliability, HbA1c had the strongest correlation with CGM measured glucose in day-to-day living (0.88, 95% CI 0.84 to 0.91), followed by FPG (0.82, 95% CI 0.76 to 0.86) and RPG (0.76, 95% CI 0.69 to 0.81). Among participants without conditions thought to affect HbA1c reliability, FPG and RPG had a similar diagnostic performance in identifying poor glycemic control defined by a range of HbA1c thresholds. FPG of ≥7.1 mmol/L and RPG of ≥10.5 mmol/L correctly identified 78.2% and 78.8%, respectively, of patients with an HbA1c of ≥7.0%. CONCLUSIONS HbA1c is the optimal test for monitoring glucose control even in low-income and middle-income countries where medical conditions that may alter its reliability are prevalent; FPG and RPG are valuable alternatives where HbA1c is not available.
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Affiliation(s)
- Anxious J Niwaha
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
- NCD Theme, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda
| | - Lauren R Rodgers
- Institute of Health Research, University of Exeter Medical School, Exeter, UK
| | - Rosamund Greiner
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
| | - Priscilla A Balungi
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
- NCD Theme, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda
| | - Raymond Mwebaze
- Department of Medicine, St. Francis Hospital Nsambya, Kampala, Uganda
| | - Timothy J McDonald
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
| | - Andrew T Hattersley
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
| | - Beverley M Shields
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
| | - Moffat J Nyirenda
- NCD Theme, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda
- NCD Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
| | - Angus G Jones
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter, Exeter, UK
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Wang H, Guo Z, Zheng Y, Yu C, Hou H, Chen B. No Casual Relationship Between T2DM and the Risk of Infectious Diseases: A Two-Sample Mendelian Randomization Study. Front Genet 2021; 12:720874. [PMID: 34527023 PMCID: PMC8435717 DOI: 10.3389/fgene.2021.720874] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/05/2021] [Accepted: 07/26/2021] [Indexed: 12/29/2022] Open
Abstract
BACKGROUND In epidemiological studies, it has been proven that the occurrence of type 2 diabetes mellitus (T2DM) is related to an increased risk of infectious diseases. However, it is still unclear whether the relationship is casual. METHODS We employed a two-sample Mendelian randomization (MR) to clarify the causal effect of T2DM on high-frequency infectious diseases: sepsis, skin and soft tissue infections (SSTIs), urinary tract infections (UTIs), pneumonia, and genito-urinary infection (GUI) in pregnancy. And then, we analyzed the genome-wide association study (GWAS) meta-analysis of European-descent individuals and conducted T2DM-related single-nucleotide polymorphisms (SNPs) as instrumental variables (IVs) that were associated with genome-wide significance (p < 5 × 10-8). MR estimates were obtained using the inverse variance-weighted (IVW), the MR-Egger regression, the simple mode (SM), weighted median, and weighted mode. RESULTS The UK Biobank (UKB) cohort (n > 500,000) provided data for GWASs on infectious diseases. MR analysis showed little evidence of a causal relationship of T2DM with five mentioned infections' (sepsis, SSTI, UTI, pneumonia, and GUI in pregnancy) susceptibility [odds ratio (OR) = 0.99999, p = 0.916; OR = 0.99986, p = 0.233; OR = 0.99973, p = 0.224; OR = 0.99997, p = 0.686; OR, 1.00002, p = 0.766]. Sensitivity analysis showed similar results, indicating the robustness of causality. There were no heterogeneity and pleiotropic bias. CONCLUSION T2DM would not be causally associated with high-frequency infectious diseases (including sepsis, SSTI, UTI, pneumonia, and GUI in pregnancy).
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Affiliation(s)
- Huachen Wang
- Intensive Care Unit, The Second Hospital of Tianjin Medical University, Tianjin, China
| | - Zheng Guo
- Centre for Precision Health, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia
| | - Yulu Zheng
- Centre for Precision Health, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia
| | - Chunyan Yu
- Medical Imaging Department, Longgang District Central Hospital of Shenzhen, Shenzhen, China
| | - Haifeng Hou
- Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, China
| | - Bing Chen
- Intensive Care Unit, The Second Hospital of Tianjin Medical University, Tianjin, China
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Holt RIG, Barnard-Kelly K, Dritsakis G, Thorne KI, Cohen L, Dixon E, Patel M, Newland-Jones P, Partridge H, Luthra S, Ohri S, Salhiyyah K, Picot J, Niven J, Cook A. Developing an intervention to optimise the outcome of cardiac surgery in people with diabetes: the OCTOPuS pilot study. Pilot Feasibility Stud 2021; 7:157. [PMID: 34404479 PMCID: PMC8368047 DOI: 10.1186/s40814-021-00887-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2020] [Accepted: 07/09/2021] [Indexed: 11/25/2022] Open
Abstract
BACKGROUND Cardiothoracic surgical outcomes are poorer in people with diabetes compared with those without diabetes. There are two important uncertainties in the management of people with diabetes undergoing major surgery: (1) how to improve diabetes management in the weeks leading up to an elective procedure and (2) whether that improved management leads to improved postoperative outcomes. The aim of this study was to develop and pilot a specialist diabetes team-led intervention to improve surgical outcomes in people with diabetes. DESIGN Open pilot feasibility study SETTING: Diabetes and cardiothoracic surgery departments, University Hospital Southampton NHS Foundation Trust PARTICIPANTS: Seventeen people with diabetes undergoing cardiothoracic surgery INTERVENTION: Following two rapid literature reviews, a prototype intervention was developed based on a previously used nurse-led outpatient intervention and tested. PRIMARY OUTCOME Feasibility and acceptability of delivering the intervention SECONDARY OUTCOMES: Biomedical data were collected at baseline and prior to surgery. We assessed how the intervention was used. In depth qualitative interviews with participants and healthcare professionals were used to explore perceptions and experiences of the intervention and how it might be improved. RESULTS Thirteen of the 17 people recruited completed the study and underwent cardiothoracic surgery. All components of the OCTOPuS intervention were used, but not all parts were used for all participants. Minor changes were made to the intervention as a result of feedback from the participants and healthcare professionals. Median (IQR) HbA1c was 10 mmol/mol (3, 13) lower prior to surgery than at baseline. CONCLUSION This study has shown that it is possible to develop a clinical pathway to improve diabetes management prior to admission. The clinical and cost-effectiveness of this intervention will now be tested in a multicentre randomised controlled trial in cardiothoracic centres across the UK. TRIAL REGISTRATION ISRCTN; ISRCTN10170306 . Registered 10 May 2018.
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Affiliation(s)
- Richard I G Holt
- Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
- Southampton National Institute for Health Research Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
| | - Katharine Barnard-Kelly
- Barnard Health-Health Psychology Research, Fareham, UK
- Faculty of Health & Social Science, Bournemouth University, Poole, UK
| | - Giorgos Dritsakis
- Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Kerensa I Thorne
- Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Lauren Cohen
- Barnard Health-Health Psychology Research, Fareham, UK
| | - Elizabeth Dixon
- Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Mayank Patel
- Diabetes Department, University Hospital Southampton, Southampton, UK
| | | | - Helen Partridge
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth, UK
| | - Suvitesh Luthra
- Division of Cardiac Surgery, Wessex Cardiothoracic Centre, University Hospital Southampton, Southampton, UK
| | - Sunil Ohri
- Division of Cardiac Surgery, Wessex Cardiothoracic Centre, University Hospital Southampton, Southampton, UK
| | - Kareem Salhiyyah
- Division of Cardiac Surgery, Wessex Cardiothoracic Centre, University Hospital Southampton, Southampton, UK
- Middle East University, Amman, Jordan
| | - Jo Picot
- Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK
| | - John Niven
- Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Andrew Cook
- Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK
- Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK
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30
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den Braber N, Vollenbroek-Hutten MMR, Westerik KM, Bakker SJL, Navis G, van Beijnum BJF, Laverman GD. Glucose Regulation Beyond HbA 1c in Type 2 Diabetes Treated With Insulin: Real-World Evidence From the DIALECT-2 Cohort. Diabetes Care 2021; 44:dc202241. [PMID: 34301732 PMCID: PMC8740938 DOI: 10.2337/dc20-2241] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2020] [Accepted: 06/24/2021] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To investigate glucose variations associated with glycated hemoglobin (HbA1c) in insulin-treated patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Patients included in Diabetes and Lifestyle Cohort Twente (DIALECT)-2 (n = 79) were grouped into three HbA1c categories: low, intermediate, and high (≤53, 54-62, and ≥63 mmol/mol or ≤7, 7.1-7.8, and ≥7.9%, respectively). Blood glucose time in range (TIR), time below range (TBR), time above range (TAR), glucose variability parameters, day and night duration, and frequency of TBR and TAR episodes were determined by continuous glucose monitoring (CGM) using the FreeStyle Libre sensor and compared between HbA1c categories. RESULTS CGM was performed for a median (interquartile range) of 10 (7-12) days/patient. TIR was not different for low and intermediate HbA1c categories (76.8% [68.3-88.2] vs. 76.0% [72.5.0-80.1]), whereas in the low category, TBR was higher and TAR lower (7.7% [2.4-19.1] vs. 0.7% [0.3-6.1] and 8.2% [5.7-17.6] vs. 20.4% [11.6-27.0], respectively, P < 0.05). Patients in the highest HbA1c category had lower TIR (52.7% [40.9-67.3]) and higher TAR (44.1% [27.8-57.0]) than the other HbA1c categories (P < 0.05), but did not have less TBR during the night. All patients had more (0.06 ± 0.06/h vs. 0.03 ± 0.03/h; P = 0.002) and longer (88.0 [45.0-195.5] vs. 53.4 [34.4-82.8] minutes; P < 0.001) TBR episodes during the night than during the day. CONCLUSIONS In this study, a high HbA1c did not reduce the occurrence of nocturnal hypoglycemia, and low HbA1c was not associated with the highest TIR. Optimal personalization of glycemic control requires the use of newer tools, including CGM-derived parameters.
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Affiliation(s)
- Niala den Braber
- Division of Nephrology, Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands
- Biomedical Signals and Systems, University of Twente, Enschede, the Netherlands
| | - Miriam M R Vollenbroek-Hutten
- Division of Nephrology, Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands
- Biomedical Signals and Systems, University of Twente, Enschede, the Netherlands
| | - Kathryn M Westerik
- Division of Nephrology, Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands
| | - Stephan J L Bakker
- Division of Nephrology, Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
| | - Gerjan Navis
- Division of Nephrology, Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
| | | | - Gozewijn D Laverman
- Division of Nephrology, Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands
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Kumar S. Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients. Indian J Endocrinol Metab 2021; 25:326-331. [PMID: 35136740 PMCID: PMC8793962 DOI: 10.4103/ijem.ijem_276_21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2021] [Accepted: 08/24/2021] [Indexed: 11/28/2022] Open
Abstract
OBJECTIVE To compare the safety and efficacy of glimepiride and vildagliptin as add-on therapy to metformin in newly diagnosed patients with type 2 diabetes mellitus (T2DM). METHODS This 24-week, prospective, comparative, observational study was conducted among newly diagnosed patients with T2DM. The primary endpoint was a change in fasting plasma glucose (FPG), postpradinal glucose (PPG), and HbA1c from the baseline to week 24. The key secondary endpoints were monitoring treatment-emergent adverse events such as hypoglycemia, overall gastrointestinal symptoms and weight gain, and electrocardiogram (ECG) findings. RESULTS A total of 100 eligible patients were divided into two groups: group A (n = 50) received vildagliptin plus metformin and group B (n = 50) received glimepiride plus metformin. The mean age of the patients was 49.98 years and 52.12 years in group A and group B, respectively. Electrocardiographic findings were within normal limits in all the patients from group A, whereas 47 patients from group B showed normal ECG findings. A significant decrease in HbA1c, fasting and post-prandial plasma glucose was observed with group A and group B from the baseline to week-24. However, at week-24, reduction in HbA1c and blood glucose parameters were comparable between the groups. Safety outcomes did not show any events of hypoglycemia with vildagliptin. Mild hypoglycemia was reported with glimepiride in five patients. CONCLUSION Vildagliptin-metformin appeared to be equally effective to glimepiride-metformin in reducing HbA1c level and blood glucose parameters, however, resulted in better adverse event profiles with lower risks of hypoglycemia.
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Affiliation(s)
- Surendra Kumar
- Department of Endocrinology, Patna Medical College, Patna, Bihar, India
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32
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Tan J, Wang Y, Liu S, Shi Q, Zhou X, Zhou Y, Yang X, Chen P, Li S. Long-Acting Metformin Vs. Metformin Immediate Release in Patients With Type 2 Diabetes: A Systematic Review. Front Pharmacol 2021; 12:669814. [PMID: 34079464 PMCID: PMC8165304 DOI: 10.3389/fphar.2021.669814] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2021] [Accepted: 04/21/2021] [Indexed: 02/05/2023] Open
Abstract
Background: Metformin, a commonly used antidiabetic medication, is available in both an immediate-release (IR) formulation and a long-acting formulation (metformin extended-release; XR). Objective: We performed a systematic review to compare the effectiveness, safety, and patient compliance and satisfaction between the metformin IR and XR formulations. Method: We searched for randomized control trials (RCTs) and observational studies comparing the effectiveness, safety, or patient compliance and satisfaction of metformin XR with metformin IR using the MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases. Following report screening, data collection, and risk of bias assessment, we separately pooled data from RCTs and observational studies using the Grading of Recommendation Assessment, Development, and Evaluation approach to rate the quality of evidence. Result: We included five RCTs, comprising a total of 1,662 patients, and one observational study, comprising 10,909 patients. In the meta-analyses, no differences were identified in outcomes of effectiveness and safety between the two forms of metformin (including change in HbA1c: mean difference (MD), 0.04%, 95% confidence interval [CI], -0.05-0.13%, fasting blood glucose: MD, -0.03 mmol/L, 95% CI, -0.22-0.15 mmol/L, postprandial blood glucose: MD, 0.50 mmol/L, 95% CI, -0.71-1.72 mmol/L, adverse events of abdominal pain: relative risk (RR), 1.15, 95% CI, 0.57-2.33, all-cause death (RR, 3.02, 95% CI 0.12-73.85), any adverse events (RR, 1.14, 95% CI 0.97-1.34), any adverse events leading to treatment discontinuation: RR, 1.51, 95% CI, 0.82-2.8, any gastrointestinal adverse events: RR, 1.09, 95% CI, 0.93-1.29, diarrhea: RR, 0.82, 95% CI, 0.53-1.27, flatulence: RR, 0.43, 95% CI, 0.15-1.23, nausea: RR, 0.97, 95% CI, 0.64-1.47, severe adverse events: RR, 0.64, 95% CI, 0.28-1.42, and vomiting: RR, 1.46, 95% CI, 0.6-3.56). Data from both the RCTs and the observational study indicate mildly superior patient compliance with metformin XR use compared with metformin IR use; this result was attributable to the preference for once-daily administration with metformin XR. Conclusion: Our systematic review indicates that metformin XR and IR formulations have similar effectiveness and safety, but that metformin XR is associated with improved compliance to treatment.
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Affiliation(s)
- Jixue Tan
- The Second School of Clinical Medicine, Nanchang University, Nanchang, China
- Department of Science and Technology, The Second Affiliated Hospital of Nanchang University, Nanchang, China
- Queen Mary School, Nanchang University, Nanchang, China
| | - Yang Wang
- Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China
- West China School of Medicine, Sichuan University, Chengdu, China
| | - Song Liu
- Department of Science and Technology, The Second Affiliated Hospital of Nanchang University, Nanchang, China
| | - Qingyang Shi
- Department of Guideline and Rapid Recommendation, Cochrane China Center, MAGIC China Center, Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
| | - Xu Zhou
- Evidence-Based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, China
| | - Yiling Zhou
- Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China
| | - Xiaoling Yang
- Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China
| | - Pingshan Chen
- Department of Science and Technology, The Second Affiliated Hospital of Nanchang University, Nanchang, China
| | - Sheyu Li
- Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China
- Department of Guideline and Rapid Recommendation, Cochrane China Center, MAGIC China Center, Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
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Robbins T, Sankaranarayanan S, Randeva H, Keung SNLC, Arvanitis TN. Association between glycosylated haemoglobin and outcomes for patients discharged from hospital with diabetes: A health informatics approach. Digit Health 2021; 7:20552076211007661. [PMID: 33948220 PMCID: PMC8054217 DOI: 10.1177/20552076211007661] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2020] [Accepted: 03/13/2021] [Indexed: 11/16/2022] Open
Abstract
Aims/Objectives Extensive research considers associations between inpatient glycaemic control and outcomes during hospital admission; this cautions against overly tight glycaemic targets. Little research considers glycaemic control following hospital discharge. This is despite a clear understanding that people with diabetes are at increased risk of negative outcomes, following discharge. We evaluate absolute and relative Hba1c values, and frequency of Hba1c monitoring, on readmission and mortality rates for people discharged from hospital with diabetes. Methods All discharges (n = 46,357) with diabetes from a major tertiary referral centre over 3 years were extracted, including biochemistry data. We conducted an evaluation of association between Hba1c, mortality and readmission, statistical significance and standardised Cohen's D effect size calculations. Results 399 patients had a Hba1c performed during their admission. 3,138 patients had a Hba1c within 1 year of discharge. Mean average Hba1c for readmissions was 57.82 vs 60.39 for not readmitted (p = 0.009, Cohen's D 0.28). Mean average number of days to Hba1c testing in readmitted was 97 vs 113 for those not readmitted (p = 0.00006, Cohen's D 0.39). Further evaluation of mortality outcomes, cohorts of T1DM and T2DM and association of relative change in Hba1c was performed. Conclusions Lower Hba1c values following discharge from hospital are significantly associated with increased risk of readmission, as is a shorter duration until testing. Similar patterns observed for mortality. Findings particularly prominent for T1DM. Further research needed to consider underlying causation and design of appropriate risk stratification models.
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Affiliation(s)
- Tim Robbins
- University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.,Institute of Digital Healthcare, WMG, University of Warwick, Coventry, UK
| | | | - Harpal Randeva
- University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.,Warwick Medical School, University of Warwick, Coventry, UK
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Kalashnikov VY, Michurova MS. [Atherosclerotic Cardiovascular Diseases and Type 2 Diabetes Mellitus - new Developments in the Treatment]. ACTA ACUST UNITED AC 2021; 61:78-86. [PMID: 33706690 DOI: 10.18087/cardio.2021.1.n1148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2020] [Accepted: 09/23/2020] [Indexed: 11/18/2022]
Abstract
Despite obvious success in the management of patients with type 2 diabetes mellitus, incidence of myocardial infarction, stroke, critical ischemia, and lower extremity amputation remains high. Results of clinical studies of new hypoglycemic drugs have demonstrated their high efficacy in decreasing mortality, incidence of cardiovascular complications, and progression of chronic heart failure. At the same time, prevention of atherothrombotic complications is essential for this patient category. Traditionally, the antiaggregant therapy with acetylsalicylic acid (ASA) is administered to patients with stable atherosclerotic diseases to reduce the risk. Attempts of reducing additionally the risk with ASA combinations with other antiplatelet drugs did not produce an expected result. Theoretical prerequisites suggested that anticoagulant supplements would increase the treatment efficacy in prevention of atherothrombotic complications in patients with cardiovascular diseases. Recently emerged oral anticoagulants can be administered at a considerably lower dose. In the COMPASS study, a combination of rivaroxaban 2.5 mg twice a day and ASA 100 mg/day compared to ASA 100 mg/day significantly reduced the total risk of stroke and cardiovascular death by 24 % and incidence of stroke and cardiovascular death by 42% and 22 %, respectively. Patients with peripheral artery disease showed for the first time improvement of prognosis, decreased number of amputations, major complications of lower extremity disease. Results of the COMPASS study confirmed the validity of influencing simultaneously the platelet and the coagulation components of hemostasis in patients with stable atherosclerotic cardiovascular diseases.
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Affiliation(s)
| | - M S Michurova
- Endocrinology National Medical Research Center, Moscow
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Yoo H, Kim Y, Jang IJ, Yu KS, Lee S. Pharmacokinetic/Pharmacodynamic Interactions Between Evogliptin and Glimepiride in Healthy Male Subjects. DRUG DESIGN DEVELOPMENT AND THERAPY 2020; 14:5179-5187. [PMID: 33262578 PMCID: PMC7699451 DOI: 10.2147/dddt.s275343] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/03/2020] [Accepted: 10/29/2020] [Indexed: 11/23/2022]
Abstract
Purpose Evogliptin, a dipeptidyl peptidase-4 inhibitor, and glimepiride, a sulfonylurea, are used to treat type 2 diabetes mellitus. In this study, we aimed to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) interactions between evogliptin and glimepiride. Materials and Methods A randomized, open-label, 3-period, 3-treatment, 2-sequence crossover study was conducted in healthy male subjects. During each period, subjects received multiple doses of evogliptin 5 mg alone (EVO), glimepiride 4 mg alone (GLI), or a combination of the two (EVO+GLI). Serial blood and urine samples were collected 168 and 24 h post dosing, respectively, for PK and PD analyses. Results Thirty-four subjects completed the study. The co-administration of evogliptin and glimepiride did not alter their plasma and urine PK profiles. For evogliptin, the geometric mean ratio (GMR) (90% confidence intervals) for the maximum plasma concentrations at steady-state (Cmax,ss) and the area under the curve during dosing interval at steady-state (AUCτ,ss) of EVO+GLI to E were 1.02 (0.98-1.06) and 0.97 (0.95-1.00), respectively. For glimepiride, the corresponding values of EVO+GLI to GLI were 1.08 (1.01-1.17) and 1.08 (1.02-1.14), respectively. All values were within the regulatory bioequivalence criteria of 0.8-1.25. Glucose excursion decreased with the co-administration of evogliptin and glimepiride compared with that observed with the evogliptin or glimepiride monotherapy. Conclusion Evogliptin and glimepiride had no PK interactions when co-administered, while the combination therapy showed an additive glucose-lowering effect compared to those of evogliptin or glimepiride monotherapy.
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Affiliation(s)
- Hyounggyoon Yoo
- Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea
| | - Yun Kim
- Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea
| | - In-Jin Jang
- Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea
| | - Kyung-Sang Yu
- Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea
| | - SeungHwan Lee
- Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea
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Chater AM, Smith L, Ferrandino L, Wyld K, Bailey DP. Health behaviour change considerations for weight loss and type 2 diabetes: nutrition, physical activity and sedentary behaviour. PRACTICAL DIABETES 2020. [DOI: 10.1002/pdi.2311] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Affiliation(s)
- Angel Marie Chater
- Centre for Health, Wellbeing and Behaviour Change, Institute for Sport and Physical Activity Research, Faculty of Education and Sport, University of Bedfordshire Bedford UK
- Centre for Behavioural Medicine, University College London UK
| | - Lindsey Smith
- Centre for Health, Wellbeing and Behaviour Change, Institute for Sport and Physical Activity Research, Faculty of Education and Sport, University of Bedfordshire Bedford UK
| | - Louise Ferrandino
- Centre for Health, Wellbeing and Behaviour Change, Institute for Sport and Physical Activity Research, Faculty of Education and Sport, University of Bedfordshire Bedford UK
| | - Kev Wyld
- Centre for Health, Wellbeing and Behaviour Change, Institute for Sport and Physical Activity Research, Faculty of Education and Sport, University of Bedfordshire Bedford UK
| | - Daniel P Bailey
- Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London Uxbridge UK
- Sedentary Behaviour, Health and Disease Research Group, Brunel University London Uxbridge UK
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Chen JF, Peng YS, Chen CS, Tseng CH, Chen PC, Lee TI, Lu YC, Yang YS, Lin CL, Hung YJ, Chen ST, Lu CH, Yang CY, Chen CC, Lee CC, Hsiao PJ, Jiang JY, Tu ST. Use and effectiveness of dapagliflozin in patients with type 2 diabetes mellitus: a multicenter retrospective study in Taiwan. PeerJ 2020; 8:e9998. [PMID: 33240585 PMCID: PMC7678460 DOI: 10.7717/peerj.9998] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2020] [Accepted: 08/28/2020] [Indexed: 01/10/2023] Open
Abstract
Aims/Introduction To investigate the clinical outcomes of patients with type 2 diabetes mellitus (T2DM) who initiated dapagliflozin in real-world practice in Taiwan. Materials and Methods In this multicenter retrospective study, adult patients with T2DM who initiated dapagliflozin after May 1st 2016 either as add-on or switch therapy were included. Changes in clinical and laboratory parameters were evaluated at 3 and 6 months. Baseline factors associated with dapagliflozin response in glycated hemoglobin (HbA1c) were analyzed by univariate and multivariate logistic regression. Results A total of 1,960 patients were eligible. At 6 months, significant changes were observed: HbA1c by −0.73% (95% confidence interval [CI] −0.80, −0.67), body weight was -1.61 kg (95% CI −1.79, −1.42), and systolic/diastolic blood pressure by −3.6/−1.4 mmHg. Add-on dapagliflozin showed significantly greater HbA1c reduction (−0.82%) than switched therapy (−0.66%) (p = 0.002). The proportion of patients achieving HbA1c <7% target increased from 6% at baseline to 19% at Month 6. Almost 80% of patients experienced at least 1% reduction in HbA1c, and 65% of patients showed both weight loss and reduction in HbA1c. Around 37% of patients had at least 3% weight loss. Multivariate logistic regression analysis indicated patients with higher baseline HbA1c and those who initiated dapagliflozin as add-on therapy were associated with a greater reduction in HbA1c. Conclusions In this real-world study with the highest patient number of Chinese population to date, the use of dapagliflozin was associated with significant improvement in glycemic control, body weight, and blood pressure in patients with T2DM. Initiating dapagliflozin as add-on therapy showed better glycemic control than as switch therapy.
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Affiliation(s)
- Jung-Fu Chen
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.,College of Medicine, Chang Gung University, Taoyuan, Taiwan
| | - Yun-Shing Peng
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan
| | - Chung-Sen Chen
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei City Hospital Zhongxiao Branch, Taipei, Taiwan
| | - Chin-Hsiao Tseng
- Division of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Pei-Chi Chen
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
| | - Ting-I Lee
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.,Department of General Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
| | - Yung-Chuan Lu
- Division of Endocrinology and Metabolism, Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan.,School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan
| | - Yi-Sun Yang
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan
| | - Ching-Ling Lin
- Department of General Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.,Division of Endocrinology and Metabolism, Department of Internal Medicine, Cathay General Hospital, Taipei, Taiwan
| | - Yi-Jen Hung
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital Songshan Branch, Taipei, Taiwan
| | - Szu-Ta Chen
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
| | - Chieh-Hsiang Lu
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.,Lutheran Medical Foundation, Kaohsiung Christian Hospital, Kaohsiung, Taiwan
| | - Chwen-Yi Yang
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan
| | - Ching-Chu Chen
- Division of Endocrinology and Metabolism, Department of Medicine, China Medical University Hospital, Taichung, Taiwan.,School of Chinese Medicine, China Medical University, Taichung, Taiwan
| | - Chun-Chuan Lee
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
| | - Pi-Jung Hsiao
- Division of Endocrinology and Metabolism, Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan
| | - Ju-Ying Jiang
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan
| | - Shih-Te Tu
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan
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Allory E, Lucas H, Maury A, Garlantezec R, Kendir C, Chapron A, Fiquet L. Perspectives of deprived patients on diabetes self-management programmes delivered by the local primary care team: a qualitative study on facilitators and barriers for participation, in France. BMC Health Serv Res 2020; 20:855. [PMID: 32917205 PMCID: PMC7488295 DOI: 10.1186/s12913-020-05715-3] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2019] [Accepted: 09/03/2020] [Indexed: 01/13/2023] Open
Abstract
Background Diabetes self-management education (DSME) is an effective intervention for patients with type 2 diabetes mellitus (T2DM); nevertheless, patient participation in this type of programme is low. Implementation of DSME programmes in primary care practices by the local multi-professional team is a potential strategy to improve access to DSME for T2DM patients. The aim of this study was to identify perceived facilitators and barriers by patients to participation in local DSME delivered by primary care professionals in France. Method T2DM patients, informed and recruited during consulting with their usual care provider, who had attended a structured and validated DSME programme delivered by 13 primary care providers within a multi-professional primary care practice in a deprived area of 20,000 inhabitants, were invited to participate in this study. A qualitative study with semi-structured, in-depth interviews was conducted with study participants, between July 2017 and February 2018. A reflexive thematic analysis of the interviews was carried out. Coding schemes were developed to generate thematic trends in patient descriptions of facilitators and barriers to DSME participation. Results Nineteen interviews (mean length 31 min; [20–44 min]) were completed with T2DM patients. Four themes on facilitators for programme participation emerged from the data: geographical proximity of a DSME programme held in the local multi-professional primary care practice; effective promotion of the DSME programme by the local multi-professional team; pre-existing relationship between patients and their healthcare providers; and potential to establish new social interactions within the neighbourhood by participating in the programme. Three themes on barriers to attendance emerged: integrating the DSME programme into their own schedules; difficulties in expressing themselves in front of a group; and keeping the motivation for self-managing their T2DM. Conclusions From the patient perspective, the programme geographical proximity and the pre-existing patient-healthcare provider relationship were important factors that contributed to participation. Healthcare providers should consider these factors to improve access to DSME programmes and diabetes self-management in deprived populations. Longitudinal studies should be performed to measure the impact of these programmes.
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Affiliation(s)
- Emmanuel Allory
- Department of general practice, University of Rennes 1, F-35000, Rennes, France. .,Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique), F-35000, Rennes, France.
| | - Hélène Lucas
- Department of general practice, University of Rennes 1, F-35000, Rennes, France
| | - Arnaud Maury
- Department of general practice, University of Rennes 1, F-35000, Rennes, France.,Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique), F-35000, Rennes, France
| | - Ronan Garlantezec
- CHU de Rennes, Univ Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, F-35000, Rennes, France
| | - Candan Kendir
- École des hautes études en santé publique (EHESP), Saint-Denis, France
| | - Anthony Chapron
- Department of general practice, University of Rennes 1, F-35000, Rennes, France.,Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique), F-35000, Rennes, France
| | - Laure Fiquet
- Department of general practice, University of Rennes 1, F-35000, Rennes, France.,Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d'Investigation Clinique), F-35000, Rennes, France
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Ng'ang'a L, Ngoga G, Dusabeyezu S, Hedt-Gauthier BL, Ngamije P, Habiyaremye M, Harerimana E, Ndayisaba G, Rusangwa C, Niyonsenga SP, Bavuma CM, Bukhman G, Adler AJ, Kateera F, Park PH. Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial. BMJ Open 2020; 10:e036202. [PMID: 32718924 PMCID: PMC7389513 DOI: 10.1136/bmjopen-2019-036202] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023] Open
Abstract
INTRODUCTION Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement. METHODS AND ANALYSIS This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants. ETHICS AND DISSEMINATION This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER PACTR201905538846394; pre-results.
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Affiliation(s)
- Loise Ng'ang'a
- Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda
| | - Gedeon Ngoga
- Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda
- NCD Synergies, Partners in Health, Boston, Massachusetts, United States
| | - Symaque Dusabeyezu
- Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda
| | | | - Patient Ngamije
- Kirehe District Hospital, Ministry of Health, Kigali, Rwanda
| | | | | | - Gilles Ndayisaba
- Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda
| | - Christian Rusangwa
- Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda
| | | | - Charlotte M Bavuma
- Internal Medicine, University of Rwanda College of Medicine and Health Sciences, Kigali, Rwanda
| | - Gene Bukhman
- NCD Synergies, Partners in Health, Boston, Massachusetts, United States
- Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA
- Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Alma J Adler
- Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA
| | - Fredrick Kateera
- Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda
| | - Paul H Park
- NCD Synergies, Partners in Health, Boston, Massachusetts, United States
- Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA
- Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA
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40
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Cox L, Wong E, Evans KM, Medcalf J, Pyart R. The Challenges of Using UK Renal Registry Data to Audit the Care of Patients with Diabetes on Renal Replacement Therapy. Nephron Clin Pract 2020; 144:440-446. [PMID: 32698181 DOI: 10.1159/000508637] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2019] [Accepted: 05/08/2020] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION Diabetes is a major cause of CKD and of mortality in patients on renal replacement therapy (RRT). Auditing the care of patients with diabetes on RRT against published guidelines relies on robust data collection. OBJECTIVE This article assesses the completeness of data items collected by the UK Renal Registry (UKRR) that are required to audit the care of patients with diabetes on RRT. METHODS The UKRR receives data on all patients receiving RRT in the UK. Patients with diabetes, diabetes type, and method of renal diagnosis were identified from primary renal disease (PRD) codes and comorbidity data for patients commencing RRT at one of the 57 renal centres in England and Wales between 2010 and 2016. The completeness of demographic and clinical data (blood pressure, cholesterol, glycated haemoglobin [HbA1c], and smoking status) was assessed for the first year of RRT. RESULTS Ninety-three per cent of all patients on RRT irrespective of diagnosis had a PRD code, but only 28/57 renal centres had comorbidity data completeness ≥70%; 34.9% of patients with diabetic nephropathy (DN) had type 1 diabetes, but this varied between centres (9.2-100%). Overall, 4.2% of DN diagnoses were by biopsy. Data completeness in the first year of RRT for cardiovascular risk factors ranged between 50.0 and 80.0%, with HbA1c data completeness being 63.0%. Of 57 centres, 20 had HbA1c data for ≥70% of patients in the first year of RRT. CONCLUSIONS There is persistent variation between renal centres in the completeness of data collected on patients with diabetes on RRT, impacting on the ability to undertake robust audit. Data linkages and expanded data permissions could see registry data play a key role in ongoing audit and research into patients with diabetes and CKD, provided adequate data can be collected.
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Affiliation(s)
- Louise Cox
- UK Renal Registry, Bristol, United Kingdom
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Leung MH, Choy EHS, Lau CS. Cumulative patient-based disease activity monitoring in rheumatoid arthritis - predicts sustained remission, flare and treatment escalation. Semin Arthritis Rheum 2020; 50:749-758. [PMID: 32531504 DOI: 10.1016/j.semarthrit.2020.03.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2019] [Revised: 03/18/2020] [Accepted: 03/24/2020] [Indexed: 11/25/2022]
Abstract
OBJECTIVE Patient-based Disease Activity Score 2 (PDAS2) had been developed for RA patients to self-assess and record disease activity in between clinic visits. This study explored the clinical utility of time-integrated cumulative PDAS2 (cPDAS2) on predicting sustained remission or low disease activity state (LDAS), flare and treatment escalation. METHODS We recruited 100 patients to record PDAS2 at home fortnightly between two consecutive clinic visits. Rheumatologists adjusted treatment according to disease activity recorded during clinic consultation while blinded to home PDAS2 scores. cPDAS2 calculated from the area-under-curve of all PDAS2 scores were compared with disease activities at both visits. cPDAS2 and ΔcPDAS2 (change from PDAS2 at the first visit) were tested to determine their ability to predict ACR/EULAR remission, SDAI flare-up (from remission/LDAS to moderate/high disease activity) and treatment escalation. Optimal cut-points were determined by Receiver Operator Characteristic curve. RESULTS Mean age of the patients was 59 years, mean RA duration 14 years, 90% were female, 71% seropositive and 64% in remission/LDAS. The home PDAS2 completion rate was 92%. PDAS2 scores were done 7.5 times every 15 days over a 16-week follow-up (all medians). The sensitivity of cPDAS2 in predicting Boolean/SDAI remission at two visits, DAS28, SDAI and CDAI remission or LDAS were 93%, 84%, 73% and 80% respectively. cPDAS2 ≥ 0.29 predicted flare (P = 0.04), with specificity 79% and negative predicting value (NPV) 88%. Rheumatologists' decision to escalate treatment was predicted by (cPDAS2 ≥ 4.33 and ΔcPDAS2 ≥ 0.059) (P = 0.007) with specificity 88% and NPV 89%, and (cPDAS2 ≥ 4.33 or ΔcPDAS2 ≥ 0.059) (P = 0.02) with both sensitivity and NPV 100%. CONCLUSION PDAS2 monitoring at home is feasible. cPDAS2 is useful to predict flare and treatment escalation.
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Affiliation(s)
- M H Leung
- Department of Medicine, Queen Elizabeth Hospital, Hong Kong
| | - Ernest H S Choy
- Institute of Infection and Immunity, Arthritis Research UK CREATE Centre and Welsh Arthritis Research Network (WARN), Cardiff University School of Medicine, Cardiff, United Kingdom
| | - C S Lau
- Department of Medicine, Queen Mary Hospital and LKS Faculty of Medicine, The University of Hong Kong, Hong Kong.
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Huttunen-Lenz M, Hansen S, Vestentoft PS, Meinert Larsen T, Westerterp-Plantenga M, Drummen M, Adam T, Macdonald I, Taylor M, Simpson E, Martinez JA, Navas-Carretero S, Handjieva-Darlenska T, Poppitt SD, Silvestre MP, Fogelholm M, Jalo E, Muirhead R, Brodie S, Brand-Miller J, Raben A, Schlicht W. Goal achievement and adaptive goal adjustment in a behavioral intervention for participants with prediabetes. J Health Psychol 2020; 26:2743-2755. [PMID: 32522040 DOI: 10.1177/1359105320925150] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Abstract
Participants with prediabetes were supported to achieve and maintain weight loss with a stage-based behavior change group program named PREview behavior Modification Intervention Toolbox (PREMIT). The tendency to engage in a process of goal adjustment was examined in relation to PREMIT attendance. Analyses were based on 1857 participants who had achieved ⩾8percent weight loss. Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance. Instead, results suggested that when unsure about reaching an intervention goal, participants were more likely to engage in a process of goal adjustment, possibly lessening distress due to potentially unachievable goals, either weight loss or maintenance.
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Affiliation(s)
| | - Sylvia Hansen
- University of Stuttgart, Germany.,University of Cologne, Germany
| | | | | | | | | | | | | | | | | | - J Alfredo Martinez
- University of Navarra, Spain.,CIBERonn Instituto de Salud Carlos III, Spain.,IMDEA Food Institute, Spain
| | | | | | | | - Martha P Silvestre
- The University of Auckland, New Zealand.,NOVA University of Lisbon, Portugal
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Davies M, Kristunas CA, Huddlestone L, Alshreef A, Bodicoat D, Dixon S, Eborall H, Glab A, Hudson N, Khunti K, Martin G, Northern A, Patterson M, Pritchard R, Schreder S, Stribling B, Turner J, Gray LJ. Increasing uptake of structured self-management education programmes for type 2 diabetes in a primary care setting: a feasibility study. Pilot Feasibility Stud 2020; 6:71. [PMID: 32477589 PMCID: PMC7243310 DOI: 10.1186/s40814-020-00606-0] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2019] [Accepted: 04/22/2020] [Indexed: 01/16/2023] Open
Abstract
Background Structured self-management education (SSME) for people with type 2 diabetes mellitus (T2DM) improves biomedical and psychological outcomes, whilst being cost-effective. Yet uptake in the UK remains low. An ‘Embedding Package’ addressing barriers and enablers to uptake at patient, health care professional and organisational levels has been developed. The aim of this study was to test the feasibility of conducting a subsequent randomised controlled trial (RCT) to evaluate the Embedding Package in primary care, using a mixed methods approach. Methods A concurrent mixed methods approach was adopted. Six general practices in the UK were recruited and received the intervention (the Embedding Package). Pseudonymised demographic, biomedical and SSME data were extracted from primary care medical records for patients recorded as having a diagnosis of T2DM. Descriptive statistics assessed quantitative data completeness and accuracy. Quantitative data were supplemented and validated by a patient questionnaire, for which two recruitment methods were trialled. Where consent was given, the questionnaire and primary care data were linked and compared. The cost of the intervention was estimated. An integrated qualitative study comprising ethnography and stakeholder and patient interviews explored the process of implementation, sustainability of change and ‘fit’ of the intervention. Qualitative data were analysed using a thematic framework guided by the Normalisation Process Theory (NPT). Results Primary care data were extracted for 2877 patients. The primary outcome for the RCT, HbA1c, was over 90% complete. Questionnaires were received from 423 (14.7%) participants, with postal invitations yielding more participants than general practitioner (GP) prompts. Ninety-one percent of questionnaire participants consented to data linkage. The mean cost per patient for the Embedding Package was £8.94, over a median follow-up of 162.5 days. Removing the development cost, this reduces to £5.47 per patient. Adoption of ethnographic and interview methods in the collection of data was appropriate, and the use of NPT, whilst challenging, enhanced the understanding of the implementation process. The need to delay the collection of patient interview data to enable the intervention to inform patient care was highlighted. Conclusions It is feasible to collect data with reasonable completeness and accuracy for the subsequent RCT, although refinement to improve the quality of the data collected will be undertaken. Based on resource use data collected, it was feasible to produce cost estimates for each individual component of the Embedding Package. The methods chosen to generate, collect and analyse qualitative data were satisfactory, keeping participant burden low and providing insight into potential refinements of the Embedding Package and customisation of the methods for the RCT. Trial registration ISRCTN, ISRCTN21321635, Registered 07/07/2017—retrospectively registered.
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Affiliation(s)
- Melanie Davies
- 1Diabetes Research Centre, University of Leicester, Leicester, UK
| | - Caroline A Kristunas
- 1Diabetes Research Centre, University of Leicester, Leicester, UK.,2Department of Health Sciences, University of Leicester, Leicester, UK
| | - Lisa Huddlestone
- 2Department of Health Sciences, University of Leicester, Leicester, UK
| | - Abualbishr Alshreef
- 3School of Health and Related Research, University of Sheffield, Sheffield, UK
| | | | - Simon Dixon
- 3School of Health and Related Research, University of Sheffield, Sheffield, UK
| | - Helen Eborall
- 2Department of Health Sciences, University of Leicester, Leicester, UK
| | - Agnieszka Glab
- 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
| | - Nicky Hudson
- 5Centre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK
| | - Kamlesh Khunti
- 1Diabetes Research Centre, University of Leicester, Leicester, UK
| | - Graham Martin
- 6THIS Institute, University of Cambridge, Cambridge, UK
| | - Alison Northern
- 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
| | - Mike Patterson
- 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
| | - Rebecca Pritchard
- 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
| | - Sally Schreder
- 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
| | - Bernie Stribling
- 4Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
| | - Jessica Turner
- 5Centre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK
| | - Laura J Gray
- 2Department of Health Sciences, University of Leicester, Leicester, UK
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Simoneau G, Moodie EEM, Azoulay L, Platt RW. Adaptive Treatment Strategies With Survival Outcomes: An Application to the Treatment of Type 2 Diabetes Using a Large Observational Database. Am J Epidemiol 2020; 189:461-469. [PMID: 31903490 DOI: 10.1093/aje/kwz272] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2019] [Revised: 12/10/2019] [Accepted: 12/10/2019] [Indexed: 01/16/2023] Open
Abstract
Sequences of treatments that adapt to a patient's changing condition over time are often needed for the management of chronic diseases. An adaptive treatment strategy (ATS) consists of personalized treatment rules to be applied through the course of a disease that input the patient's characteristics at the time of decision-making and output a recommended treatment. An optimal ATS is the sequence of tailored treatments that yields the best clinical outcome for patients sharing similar characteristics. Methods for estimating optimal adaptive treatment strategies, which must disentangle short- and long-term treatment effects, can be theoretically involved and hard to explain to clinicians, especially when the outcome to be optimized is a survival time subject to right-censoring. In this paper, we describe dynamic weighted survival modeling, a method for estimating an optimal ATS with survival outcomes. Using data from the Clinical Practice Research Datalink, a large primary-care database, we illustrate how it can answer an important clinical question about the treatment of type 2 diabetes. We identify an ATS pertaining to which drug add-ons to recommend when metformin in monotherapy does not achieve the therapeutic goals.
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Glycemic control and use of glucose-lowering medications in hospital-admitted type 2 diabetes patients over 80 years. Sci Rep 2020; 10:4095. [PMID: 32139733 PMCID: PMC7057984 DOI: 10.1038/s41598-020-60818-5] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2019] [Accepted: 01/27/2020] [Indexed: 01/16/2023] Open
Abstract
Treatment guidelines for type 2 diabetes (T2D) recommend avoidance of hypoglycemia and less stringent glycemic control in older patients. We examined the relation of glycemic control to glucose-lowering medications use in a cohort of patients aged>80 years with a diagnosis of T2D and a hospital admission in the Capital Region of Denmark in 2012-2016. We extracted data on medication use, diagnoses, and biochemistry from the hospitals' records. We identified 5,172 T2D patients with high degree of co-morbidity and where 17% had an HbA1c in the range recommended for frail, comorbid, older patients with type 2 diabetes (58-75 mmol/mol (7.5-9%)). Half of the patients (n = 2,575) had an HbA1c <48 mmol/mol (<6.5%), and a majority of these (36% of all patients) did not meet the diagnostic criteria for T2D. Of patients treated with one or more glucose-lowering medications (n = 1,758), 20% had HbA1c-values <42 mmol/mol (<6%), and 1% had critically low Hba1c values <30 mmol/mol (<4.9%), In conclusion, among these hospitalized T2D patients, few had an HbA1c within the generally recommended glycemic targets. One third of patients did not meet the diagnostic criteria for T2D, and of the patients who were treated with glucose-lowering medications, one-fifth had HbA1c-values suggesting overtreatment.
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Cannon AJ, Bargiota A, Billings L, Hunt B, Leiter LA, Malkin S, Mocarski M, Ranthe MF, Schiffman A, Doshi A. Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Basal Insulin and Basal-Bolus Therapy in Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets. J Manag Care Spec Pharm 2020; 26:143-153. [PMID: 31856636 PMCID: PMC10391176 DOI: 10.18553/jmcp.2019.19035] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
BACKGROUND Effective glycemic control can reduce the risk of complications and their related costs in patients with type 2 diabetes (T2D). Many patients fail to reach hemoglobin A1c (HbA1c) ≤ 6.5% or < 7.0%, often due to adverse effects of treatment, such as hypoglycemia and weight gain. Glycemic targets should be individualized and consider multiple factors, including the risk of adverse events and the patient's characteristics and comorbid conditions. OBJECTIVE To compare the odds and annual cost of achieving treatment targets, which incorporate HbA1c targets of < 7.5%, < 8.0%, and ≤ 9.0%, with insulin degludec/liraglutide (IDegLira) versus basal insulin and basal-bolus therapy. METHODS This is a post hoc analysis of the DUAL V and DUAL VII 26-week trials, which randomized patients with T2D uncontrolled (HbA1c 7%-10%) on insulin glargine 100 units/mL (IGlar U100) and metformin to IDegLira or continued IGlar U100 titration (DUAL V) or IGlar U100 + insulin aspart (DUAL VII), all with metformin. Proportions of patients achieving HbA1c targets (< 7.5%, < 8.0%, and ≤ 9.0%) by the end of trial were assessed via 3 outcomes: alone, without either hypoglycemia or weight gain (double composite outcome), or without a combination of hypoglycemia and weight gain (triple composite outcome). The cost per patient achieving the triple composite outcome at each HbA1c target (< 7.5%, < 8.0%, and ≤ 9.0%) was calculated by dividing the annual cost of treatment by the proportion of patients achieving the target. This short-term (1-year) cost-effectiveness analysis was conducted from the perspective of a U.S. health care payer. RESULTS More patients achieved HbA1c < 7.5% (P < 0.0001) and < 8.0% (P = 0.0003), and a similar percentage achieved HbA1c ≤ 9.0% with IDegLira versus IGlar U100 (DUAL V). Similar proportions of patients achieved all 3 HbA1c targets with IDegLira compared with basal-bolus therapy (DUAL VII). The odds of achieving double or triple composite outcomes were significantly higher for IDegLira versus IGlar U100 or basal-bolus for all 3 HbA1c targets (P < 0.0001 in each case) in both trials. For each $1 spent on IDegLira, the equivalent annual costs per patient to achieve HbA1c targets of < 7.5%, < 8.0%, or ≤ 9.0% without hypoglycemia and without weight gain were $2.43, $2.10, and $2.05, respectively, for IGlar U100 and $6.33, $5.80, and $6.06, respectively, for basal-bolus therapy. CONCLUSIONS Based on data from DUAL V and DUAL VII, this analysis showed that a greater or similar proportion of patients with T2D reached HbA1c targets with IDegLira compared with IGlar U100/basal-bolus therapy. Odds of achieving double or triple composite outcomes of HbA1c reduction without hypoglycemia and/or without weight gain were greatest for IDegLira. Short-term cost analyses based on the triple composite outcomes suggest that IDegLira is a cost-effective treatment option in the United States compared with either uptitration of IGlar U100 or basal-bolus therapy. DISCLOSURES This study was supported by Novo Nordisk A/S. The analysis was based on the DUAL V (NCT01952145) and DUAL VII (NCT02420262) trials, which were funded and conducted by Novo Nordisk. This post hoc analysis was conceived and interpreted by the authors and drafted with medical writing support that was funded by Novo Nordisk. Novo Nordisk also reviewed the manuscript for medical accuracy. Hunt and Malkin are employees of Ossian Health Economics and Communications, which received consulting fees from Novo Nordisk during the conduct of this study and has received consulting fees from Novo Nordisk, unrelated to this study. Mocarski, Ranthe, and Schiffman are employees of Novo Nordisk and Novo Nordisk A/S. Cannon has received speaker fees/honoraria from Abbvie, Amgen, and Janssen; speaker fees from Novo Nordisk; and has stock ownership in Novo Nordisk. Bargiota has received speaker fees/honoraria from AstraZeneca, Eli Lilly, MSD, Novo Nordisk, Sanofi, Boehringer Ingelheim, and Novartis. Billings has received personal fees from Novo Nordisk, Sanofi, and Dexcom, unrelated to this study. Leiter reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Servier, and GSK, unrelated to this study. Doshi has no relevant conflicts of interest to disclose. Parts of this study were presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.
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Affiliation(s)
| | - Alexandra Bargiota
- Department of Endocrinology and Metabolic Diseases, University Hospital of Larissa, Larissa, Greece
| | - Liana Billings
- NorthShore University HealthSystem, Skokie, Illinois, and University of Chicago Pritzker School of Medicine, Chicago, Illinois
| | - Barnaby Hunt
- Ossian Health Economics and Communications, Basel, Switzerland
| | - Lawrence A. Leiter
- Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Ontario
| | - Samuel Malkin
- Ossian Health Economics and Communications, Basel, Switzerland
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Bang C, Mortensen MB, Lauridsen KG, Bruun JM. Trends in antidiabetic drug utilization and expenditure in Denmark: A 22-year nationwide study. Diabetes Obes Metab 2020; 22:167-172. [PMID: 31486269 DOI: 10.1111/dom.13877] [Citation(s) in RCA: 36] [Impact Index Per Article: 7.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2019] [Revised: 08/22/2019] [Accepted: 09/02/2019] [Indexed: 01/09/2023]
Abstract
AIMS To examine the nationwide trends in antidiabetic drug utilization and expenditure in Denmark over the past 22 years. METHODS Data on antidiabetic use and expenditure from 1996 to 2017 were retrieved from the Register of Medicinal Product Statistics. Antidiabetic drug use is reported as defined daily dose (DDD) in total counts and per 1000 inhabitants/d. Expenditure is reported as volume sold in total counts per 1000 inhabitants and as annual mean expenditure. RESULTS Throughout the study period, the total use of antidiabetic drugs increased from 16.4 to 55.8 DDDs per 1000 inhabitants/d, while total expenditure increased from €59 to €286 m. The introduction of glucagon-like peptide-1 receptor agonists (GLP-1RAs), dipeptidyl peptidase-4 inhibitors and sodium-glucose co-transporter-2 inhibitors has, since 2005, led to considerable variation in the proportional use of the different drug classes. Use of insulin and insulin analogues accounted for the majority of the cost of antidiabetic drugs, peaking at 75% in 2008; however, its proportional impact on overall antidiabetic drug expenditure decreased to ~44% in 2017. In contrast, a steep increase in GLP-1RA expenditure was observed from 2010 to 2017, reaching an annual cost of €85 m (~29% of all antidiabetic expenditure). CONCLUSION Antidiabetic drug utilization and cost in Denmark has increased considerably over the last 22 years, in accordance with the increased incidence of type 2 diabetes and changes in treatment guidelines. The release of several novel antidiabetic drugs seems to be responsible for the increase in antidiabetic drug expenditure.
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Affiliation(s)
- Camilla Bang
- Research Centre for Emergency Medicine, Aarhus University Hospital, Aarhus, Denmark
- Clinical Research Unit, Randers Regional Hospital, Randers, Denmark
- Department of Internal Medicine, Randers Regional Hospital, Randers, Denmark
| | - Martin B Mortensen
- Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark
| | - Kasper G Lauridsen
- Research Centre for Emergency Medicine, Aarhus University Hospital, Aarhus, Denmark
- Clinical Research Unit, Randers Regional Hospital, Randers, Denmark
- Department of Internal Medicine, Randers Regional Hospital, Randers, Denmark
| | - Jens M Bruun
- Department of Internal Medicine, Randers Regional Hospital, Randers, Denmark
- Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark
- Steno Diabetes Centre Aarhus, Aarhus, Denmark
- Department of Nutrition, Exercise and Sports, Copenhagen University Hospital, Copenhagen, Denmark
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Shin J, Kim H, Kim HS, Kim C, Choi WS. Increasing Individual Target Glucose Levels to Prevent Hypoglycemia in Patients with Diabetes. Korean J Fam Med 2020; 42:269-273. [PMID: 31995965 PMCID: PMC8321904 DOI: 10.4082/kjfm.19.0161] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2019] [Accepted: 12/13/2019] [Indexed: 12/13/2022] Open
Abstract
Hypoglycemia is one of the severe complications of diabetes. To prevent hypoglycemia, an emphasis is placed on maintaining an appropriate balance between nutrition, activity, and treatment, which can be achieved by the repetition of self-trials based on self-monitoring. Clinicians routinely focus on patients’ contribution, including timely intake of an adequate amount of carbohydrates, physical activity, antidiabetic medication, and abstinence from alcohol. Recently, many guidelines have highlighted the importance of clinicians’ factors and recommend individualized treatments according to lifestyle patterns and specific needs following the de-intensification of treatment. The optimal value of hemoglobin A1c (HbA1c) levels for blood glucose level regulation remains controversial among countries, but it generally does not exceed 8.0%. In populations that are at a risk of hypoglycemia, such as the older adults, it is advisable to adjust the target blood glucose level to less than 8.0%. Meanwhile, a blood glucose level of 7.0%–7.5% is generally recommended for healthy older adults. If the expected lifetime is shorter than 10 years or in patients with chronic kidney disease and severe cardiovascular disease, the HbA1c level target can be increased to 7.5%–8.0%. For even shorter lifetime expectancy, the target can be adjusted up to 8.0%–9.0%. To prevent hypoglycemia, the target blood glucose level needs to be adjusted, particularly in older adult patients. Ultimately, it is important to identify the maximum blood glucose levels that do not cause hypoglycemia and the minimum blood glucose levels that do not cause hyperglycemia-associated complications.
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Affiliation(s)
- Juyoung Shin
- Health Promotion Center, Seoul St. Mary's Hospital, Seoul, Korea.,Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hyunah Kim
- College of Pharmacy, Sookmyung Women's University, Seoul, Korea
| | - Hun-Sung Kim
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.,Department of Medical Informatics, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Churlmin Kim
- Department of Family Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Whan-Seok Choi
- Department of Family Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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Fangel MV, Nielsen PB, Kristensen JK, Larsen TB, Overvad TF, Lip GYH, Jensen MB. Glycemic Status and Thromboembolic Risk in Patients With Atrial Fibrillation and Type 2 Diabetes Mellitus: A Danish Cohort Study. Circ Arrhythm Electrophysiol 2020; 12:e007030. [PMID: 30995869 DOI: 10.1161/circep.118.007030] [Citation(s) in RCA: 32] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Background Diabetes mellitus is associated with increased risk of stroke in patients with atrial fibrillation, and differences in glycemic status may affect this risk. We aimed to examine the effect of glycemic status evaluated by hemoglobin A1c (HbA1c) on the risk of thromboembolism among patients with atrial fibrillation and type 2 diabetes mellitus. Methods In this cohort study, we used data from Danish registries to identify patients with type 2 diabetes mellitus and incident nonvalvular atrial fibrillation in the period of May 1, 2005, through December 31, 2015. On the basis of the most recent HbA1c measurement before an incident atrial fibrillation diagnosis, patients were divided into the categories: HbA1c ≤48 mmol/mol, HbA1c=49-58 mmol/mol, and HbA1c >58 mmol/mol. Cox regression analysis was used to estimate hazard ratios for the outcome thromboembolism. Results The study population included 5386 patients with incident nonvalvular atrial fibrillation and type 2 diabetes mellitus. Compared with patients with HbA1c ≤48 mmol/mol, we observed a higher risk of thromboembolism among patients with HbA1c=49-58 mmol/mol (hazard ratio, 1.49; 95% CI, 1.09-2.05) and HbA1c >58 mmol/mol (hazard ratio, 1.59; 95% CI, 1.13-2.22) after adjusting for confounding factors. When stratified on diabetes mellitus duration, similar results were found among patients with diabetes mellitus duration of <10 years. Contrastingly, in patients with diabetes mellitus duration of ≥10 years, higher HbA1c levels were not associated with a higher risk of thromboembolism. Conclusions In patients with incident atrial fibrillation and type 2 diabetes mellitus, increasing levels of HbA1c were associated with a higher risk of thromboembolism. However, no association was found among patients with diabetes mellitus duration ≥10 years.
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Affiliation(s)
- Mia Vicki Fangel
- Center for General Practice (M.V.F., J.K.K., M.B.J.), Aalborg University, Denmark
| | - Peter Brønnum Nielsen
- Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health (P.B.N., T.B.L., T.F.O., G.Y.H.L.), Aalborg University, Denmark.,Department of Cardiology, Atrial Fibrillation Study Group, Aalborg University Hospital, Denmark (P.B.N., T.B.L.)
| | | | - Torben Bjerregaard Larsen
- Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health (P.B.N., T.B.L., T.F.O., G.Y.H.L.), Aalborg University, Denmark.,Department of Cardiology, Atrial Fibrillation Study Group, Aalborg University Hospital, Denmark (P.B.N., T.B.L.)
| | - Thure Filskov Overvad
- Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health (P.B.N., T.B.L., T.F.O., G.Y.H.L.), Aalborg University, Denmark.,Department of Medicine, North Denmark Regional Hospital, Hjørring, Denmark (T.F.O.)
| | - Gregory Y H Lip
- Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health (P.B.N., T.B.L., T.F.O., G.Y.H.L.), Aalborg University, Denmark.,Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, United Kingdom (G.Y.H.L.)
| | - Martin Bach Jensen
- Center for General Practice (M.V.F., J.K.K., M.B.J.), Aalborg University, Denmark
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Shao H, Lin J, Zhuo X, Rolka DB, Gregg EW, Zhang P. Influence of Diabetes Complications on HbA 1c Treatment Goals Among Older U.S. Adults: A Cost-effectiveness Analysis. Diabetes Care 2019; 42:2136-2142. [PMID: 31530661 DOI: 10.2337/dc19-0381] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2019] [Accepted: 08/21/2019] [Indexed: 02/03/2023]
Abstract
OBJECTIVE Guidelines on the standard care of diabetes recommend that glycemic treatment goals for older adults consider the patient's complications and life expectancy. In this study, we examined the influence of diabetes complications and associated life expectancies on the cost-effectiveness (CE) of HbA1c treatment goals. RESEARCH DESIGN AND METHODS We used data from the 2011-2016 National Health and Nutrition Examination Survey (NHANES) to generate nationally representative subgroups of older individuals with diabetes with various health states. We used the Centers for Disease Control and Prevention-RTI International diabetes CE model to estimate the long-term consequences of two treatment goals-a stringent control goal (HbA1c <7.5%) and a moderate control goal (HbA1c <8.5%)-on health and cost. Our simulation population represented typical patients, and all individuals in each health subgroup had average characteristics, which did not account for person-level variations. The CE study was conducted from a health system perspective and followed the study samples over a lifetime. We used $50,000 per quality-adjusted life year (QALY) as the incremental CE threshold. RESULTS A stringent goal was, on average, cost-effective for individuals with no complications ($10,007 per QALY) or only microvascular complications (excluding renal failure; $19,621 per QALY), but it was not cost-effective for individuals with one or more macrovascular complications (all >$82,413 per QALY). Further, a stringent goal was not cost-effective when an individual had less than 7 years of life remaining. CONCLUSIONS Our findings support the guideline recommendation that glycemic goals for older adults should consider the complexity of their complications and their life expectancy from a CE perspective.
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Affiliation(s)
- Hui Shao
- Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, GA .,Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL
| | - Ji Lin
- Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, GA
| | | | - Deborah B Rolka
- Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, GA
| | - Edward W Gregg
- Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, GA.,Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, U.K
| | - Ping Zhang
- Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, GA
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