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Hannah K, Nemlekar P, Bushman JS, Norman GJ. Risk of hypoglycaemia among people with type 2 diabetes not treated with insulin: A retrospective analysis of Medicare Advantage beneficiaries. Diabetes Obes Metab 2025; 27:54-60. [PMID: 39344852 DOI: 10.1111/dom.15982] [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: 07/29/2024] [Revised: 09/12/2024] [Accepted: 09/13/2024] [Indexed: 10/01/2024]
Abstract
AIMS In 2022, the Centers for Medicare & Medicaid Services released proposed changes to Medicare's continuous glucose monitoring (CGM) coverage policy, making individuals with a history of problematic hypoglycaemia eligible for CGM coverage, irrespective of insulin use. This study estimated the burden of hypoglycaemia in Medicare Advantage beneficiaries with noninsulin-treated type 2 diabetes (T2D). MATERIALS AND METHODS We retrospectively analysed US healthcare claims data using Optum's deidentified Clinformatics® database. Noninsulin-treated beneficiaries were identified in the 16 years from January 2007 to March 2023. Hypoglycaemia-related encounters (HREs) were those accompanied by a hypoglycaemia-specific ICD-9/10 diagnosis code in any position on the claim or the first or second position. HREs following the first claim related to T2D were reported by setting (ambulatory or inpatient/emergency department [ED]). RESULTS HREs were identified in 689,853 (21.4%) of 3,229,695 noninsulin-treated Medicare Advantage beneficiaries, of whom 82.9% (n = 571,581) had ≥1 HRE in an ambulatory location and 26.8% (n = 184,833) in an ED/inpatient location. Use of sulfonylurea (odds ratio [OR]: 4.33 confidence interval [CI: 4.27-4.38]), evidence of end-stage kidney disease (OR: 2.87 [CI: 2.79-2.94]), hypertension (OR: 3.09 [CI: 3.04-3.15]) and retinopathy (OR: 2.94 [CI: 2.82-3.07]) were the strongest predictors of an HRE (p < 0.001). CONCLUSIONS These findings show that HREs are prevalent in noninsulin-treated diabetes and identify a large number of patients who may benefit from CGM. Because >80% of HREs occur in the ambulatory setting and >70% occur in patients not taking sulfonylureas, primary care providers should be aware of the latest eligibility criteria for Medicare's coverage of CGM and not restrict this technology to their sulfonylurea-treated patients.
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Hunt NJ, Lockwood GP, Heffernan SJ, Daymond J, Ngu M, Narayanan RK, Westwood LJ, Mohanty B, Esser L, Williams CC, Kuncic Z, McCourt PAG, Le Couteur DG, Cogger VC. Oral nanotherapeutic formulation of insulin with reduced episodes of hypoglycaemia. NATURE NANOTECHNOLOGY 2024; 19:534-544. [PMID: 38168926 PMCID: PMC11026164 DOI: 10.1038/s41565-023-01565-2] [Citation(s) in RCA: 23] [Impact Index Per Article: 23.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/03/2023] [Accepted: 11/02/2023] [Indexed: 01/05/2024]
Abstract
Injectable insulin is an extensively used medication with potential life-threatening hypoglycaemic events. Here we report on insulin-conjugated silver sulfide quantum dots coated with a chitosan/glucose polymer to produce a responsive oral insulin nanoformulation. This formulation is pH responsive, is insoluble in acidic environments and shows increased absorption in human duodenum explants and Caenorhabditis elegans at neutral pH. The formulation is sensitive to glucosidase enzymes to trigger insulin release. It is found that the formulation distributes to the liver in mice and rats after oral administration and promotes a dose-dependent reduction in blood glucose without promoting hypoglycaemia or weight gain in diabetic rodents. Non-diabetic baboons also show a dose-dependent reduction in blood glucose. No biochemical or haematological toxicity or adverse events were observed in mice, rats and non-human primates. The formulation demonstrates the potential to orally control blood glucose without hypoglycaemic episodes.
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Affiliation(s)
- Nicholas J Hunt
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
- Sydney Nano Institute, The University of Sydney, Camperdown, New South Wales, Australia.
- Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia.
| | - Glen P Lockwood
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia
| | - Scott J Heffernan
- Royal Prince Alfred Hospital, SLHD, Camperdown, New South Wales, Australia
| | - Jarryd Daymond
- Sydney Nano Institute, The University of Sydney, Camperdown, New South Wales, Australia
- Sydney Business School, The University of Sydney, Camperdown, New South Wales, Australia
| | - Meng Ngu
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia
- Department of Gastroenterology, Concord Repatriation General Hospital, SLHD, Concord, New South Wales, Australia
| | - Ramesh K Narayanan
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia
| | - Lara J Westwood
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
- Sydney Nano Institute, The University of Sydney, Camperdown, New South Wales, Australia
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia
| | - Biswaranjan Mohanty
- Sydney Analytical Core Research Facility, The University of Sydney, Camperdown, New South Wales, Australia
| | - Lars Esser
- CSIRO Manufacturing, Clayton, Victoria, Australia
| | | | - Zdenka Kuncic
- Sydney Nano Institute, The University of Sydney, Camperdown, New South Wales, Australia
- School of Physics, The University of Sydney, Camperdown, New South Wales, Australia
| | - Peter A G McCourt
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia
- Department of Medical Biology, University of Tromsø-The Arctic University of Norway, Tromsø, Norway
| | - David G Le Couteur
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
- Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia
| | - Victoria C Cogger
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
- ANZAC Research Institute, Concord Repatriation General Hospital, Sydney Local Health District (SLHD), Concord, New South Wales, Australia.
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Kaiserman KB, Christiansen M, Bhavsar S, Ulloa J, Santogatta B, Hanna J, Bailey TS. Reduction in Postprandial Peak Glucose With Increased Technosphere Insulin Dosage. J Diabetes Sci Technol 2024; 18:397-401. [PMID: 35833638 PMCID: PMC10973860 DOI: 10.1177/19322968221110622] [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] [Indexed: 11/17/2022]
Abstract
BACKGROUND Technosphere Insulin (TI) is an ultra-rapid-acting inhaled insulin. This study assessed the mean peak two-hour postprandial glucose concentration with the initial TI dose (dose 1) calculated per the current label (United State Prescribing Information) compared with a ~2× higher dose (dose 2). Secondary objectives were to evaluate hypoglycemia within the two-hour postprandial period, evaluate change in forced expiratory volume in one second (FEV1) before and after the two-hour postprandial period, and monitor for other adverse events. METHODS Twenty patients with diabetes, on basal-bolus insulin therapy, received an initial dose 1 of TI followed by the higher dose 2, one to three days later. Subjects received an identical meal for both visits, and TI doses were administered immediately prior to the meal. RESULTS The higher dose 2 provided significant reductions in mean postprandial glucose excursion (PPGE) in the two-hour postprandial period starting from 45 minutes (P = .008) to 120 minutes (P < .0001). Mean peak glucose was reduced from 228.6 to 179.3 mg/dL (P < .001) at two hours. Two hypoglycemic events (one level 1, one level 2) were observed in a single subject during the two-hour postprandial period with dose 2. There were no significant changes in FEV1 after either dose of TI. CONCLUSIONS The higher dose 2 reduced PPGE versus the current label recommended dose 1 within the two-hour postprandial timeframe without any new safety concerns. When confirmed with a larger study, this higher TI dosing recommendation may help patients and clinicians minimize immediate postprandial hyperglycemia when titrating TI for prandial glucose control.
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Alshannaq H, Pollock RF, Joubert M, Ahmed W, Norman GJ, Lynch PM, Roze S. Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type II diabetes in France. J Comp Eff Res 2024; 13:e230174. [PMID: 38294332 PMCID: PMC10945438 DOI: 10.57264/cer-2023-0174] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2023] [Accepted: 01/09/2024] [Indexed: 02/01/2024] Open
Abstract
Aim: Clinical trials and real-world data for Type II diabetes both show that glycated hemoglobin (HbA1c) levels and hypoglycemia occurrence can be reduced by real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG). The present cost-utility study investigated the long-term health economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type II diabetes in France. Materials & methods: Effectiveness data were obtained from a real-world study, which showed rt-CGM reduced HbA1c by 0.56% (6.1 mmol/mol) versus sustained SMBG. Analyses were conducted using the IQVIA Core Diabetes Model. A French payer perspective was adopted over a lifetime horizon for a cohort aged 64.5 years with baseline HbA1c of 8.3% (67 mmol/mol). A willingness-to-pay threshold of €147,093 was used, and future costs and outcomes were discounted at 4% annually. Results: The analysis projected quality-adjusted life expectancy was 8.50 quality-adjusted life years (QALYs) for rt-CGM versus 8.03 QALYs for SMBG (difference: 0.47 QALYs), while total mean lifetime costs were €93,978 for rt-CGM versus €82,834 for SMBG (difference: €11,144). This yielded an incremental cost-utility ratio (ICUR) of €23,772 per QALY gained for rt-CGM versus SMBG. Results were particularly sensitive to changes in the treatment effect (i.e., change in HbA1c), annual price and quality of life benefit associated with rt-CGM, SMBG frequency, baseline patient age and complication costs. Conclusion: The use of rt-CGM is likely to be cost-effective versus SMBG for people with insulin-treated Type II diabetes in France.
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Affiliation(s)
- Hamza Alshannaq
- Dexcom, San Diego, CA, USA
- University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | | | - Michael Joubert
- Diabetes Care Unit, Caen University Hospital, UNICAEN, Caen, France
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Fariman SA, Nosrati M, Rahmani P, Nikfar S. A cost-effectiveness analysis of linagliptin add-on to insulin treatment for patients with type 2 diabetes mellitus and chronic kidney disease in Iran. J Diabetes Metab Disord 2023; 22:1263-1271. [PMID: 37975115 PMCID: PMC10638343 DOI: 10.1007/s40200-023-01243-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/17/2023] [Accepted: 05/27/2023] [Indexed: 11/19/2023]
Abstract
Purpose With the high prevalence of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM), determining optimal treatment strategies has become a major concern. Linagliptin is aDPP-4 inhibitor that does not require dose adjustment in patients with renal impairment. This study evaluates the cost-effectiveness of adding linagliptin to insulin therapy in patients with T2DM and mild (stage 2) or moderate (stage 3) CKD from a health system perspective in Iran. Methods We developed a cost-utility model using a decision tree and ran it separately for T2DM patients with mild or moderate CKD. Clinical outcomes and health-state utility values were extracted from published studies. Direct medical costs were obtained from national tariffs in Iran in 2021. We adopted an annual time horizon and calculated the difference in costs and quality-adjusted life-years (QALYs) to obtain the incremental cost-effectiveness ratios (ICER). To capture parameter uncertainties, one-way sensitivity analyses were also performed. Results In T2DM patients with mild CKD, the linagliptin add-on strategy was associated with an additional $23.69 cost and 0.0148 QALYs per patient, resulting in an ICER of 1600.37 USD/QALY. In moderate CKD, the strategy was associated with $22.59 more costs and 0.0191 more QALYs, and the ICER was estimated at 1182.72 USD/QALY. In both populations, the ICER was mainly driven by the impact of HbA1c on utility, cost of linagliptin, and the reduction in insulin usage by adding linagliptin to the treatment. Conclusion With a cost-effectiveness threshold of $1550 USD/QALY in Iran, adding linagliptin to insulin is cost-effective in patients with T2DM and moderate CKD. However, for those with mild CKD, it seems that the associated costs outweigh the expected benefits. Supplementary Information The online version contains supplementary material available at 10.1007/s40200-023-01243-z.
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Affiliation(s)
- Soroush Ahmadi Fariman
- Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar St., Enghelab-E Islami Sq, Tehran, Iran
| | - Marzieh Nosrati
- Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar St., Enghelab-E Islami Sq, Tehran, Iran
| | - Parham Rahmani
- Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar St., Enghelab-E Islami Sq, Tehran, Iran
| | - Shekoufeh Nikfar
- Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar St., Enghelab-E Islami Sq, Tehran, Iran
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Worth C, Nutter PW, Salomon-Estebanez M, Auckburally S, Dunne MJ, Banerjee I, Harper S. The behaviour change behind a successful pilot of hypoglycaemia reduction with HYPO-CHEAT. Digit Health 2023; 9:20552076231192011. [PMID: 37545627 PMCID: PMC10403985 DOI: 10.1177/20552076231192011] [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: 11/21/2022] [Accepted: 07/18/2023] [Indexed: 08/08/2023] Open
Abstract
Background Children with hypoglycaemia disorders, such as congenital hyperinsulinism (CHI), are at constant risk of hypoglycaemia (low blood sugars) with the attendant risk of brain injury. Current approaches to hypoglycaemia detection and prevention vary from fingerprick glucose testing to the provision of continuous glucose monitoring (CGM) to machine learning (ML) driven glucose forecasting. Recent trends for ML have had limited success in preventing free-living hypoglycaemia, due to a focus on increasingly accurate glucose forecasts and a failure to acknowledge the human in the loop and the essential step of changing behaviour. The wealth of evidence from the fields of behaviour change and persuasive technology (PT) allows for the creation of a theory-informed and technologically considered approach. Objectives We aimed to create a PT that would overcome the identified barriers to hypoglycaemia prevention for those with CHI to focus on proactive prevention rather than commonly used reactive approaches. Methods We used the behaviour change technique taxonomy and persuasive systems design models to create HYPO-CHEAT (HYpoglycaemia-Prevention-thrOugh-Cgm-HEatmap-Assisted-Technology): a novel approach that presents aggregated CGM data in simple visualisations. The resultant ease of data interpretation is intended to facilitate behaviour change and subsequently reduce hypoglycaemia. Results HYPO-CHEAT was piloted in 10 patients with CHI over 12 weeks and successfully identified weekly patterns of hypoglycaemia. These patterns consistently correlated with identifiable behaviours and were translated into both a change in proximal fingerprick behaviour and ultimately, a significant reduction in aggregated hypoglycaemia from 7.1% to 5.4% with four out of five patients showing clinically meaningful reductions in hypoglycaemia. Conclusions We have provided pilot data of a new approach to hypoglycaemia prevention that focuses on proactive prevention and behaviour change. This approach is personalised for individual patients with CHI and is a first step in changing our approach to hypoglycaemia prevention in this group.
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Affiliation(s)
- Chris Worth
- Department of Computer Science, University of Manchester, Manchester, UK
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
| | - Paul W Nutter
- Department of Computer Science, University of Manchester, Manchester, UK
| | - Maria Salomon-Estebanez
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
| | - Sameera Auckburally
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
- Faculty of Health and Medicine, Lancaster University, Lancaster, UK
| | - Mark J Dunne
- Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Indraneel Banerjee
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
- Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Simon Harper
- Department of Computer Science, University of Manchester, Manchester, UK
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Worth C, Nutter PW, Dunne MJ, Salomon-Estebanez M, Banerjee I, Harper S. HYPO-CHEAT's aggregated weekly visualisations of risk reduce real world hypoglycaemia. Digit Health 2022; 8:20552076221129712. [PMID: 36276186 PMCID: PMC9580093 DOI: 10.1177/20552076221129712] [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: 03/28/2022] [Accepted: 10/13/2021] [Indexed: 11/05/2022] Open
Abstract
Background Children with congenital hyperinsulinism (CHI) are at constant risk of hypoglycaemia with the attendant risk of brain injury. Current hypoglycaemia prevention methods centre on the prediction of a continuous glucose variable using machine learning (ML) processing of continuous glucose monitoring (CGM). This approach ignores repetitive and predictable behavioural factors and is dependent upon ongoing CGM. Thus, there has been very limited success in reducing real-world hypoglycaemia with a ML approach in any condition. Objectives We describe the development of HYPO-CHEAT (HYpoglycaemia-Prevention-thrOugh-CGM-HEatmap-Technology), which is designed to overcome these limitations by describing weekly hypoglycaemia risk. We tested HYPO-CHEAT in a real-world setting to evaluate change in hypoglycaemia. Methods HYPO-CHEAT aggregates individual CGM data to identify weekly hypoglycaemia patterns. These are visualised via a hypoglycaemia heatmap along with actionable interpretations and targets. The algorithm is iterative and reacts to anticipated changing patterns of hypoglycaemia. HYPO-CHEAT was compared with Dexcom Clarity's pattern identification and Facebook Prophet's forecasting algorithm using data from 10 children with CHI using CGM for 12 weeks. HYPO-CHEAT's efficacy was assessed via change in time below range (TBR). Results HYPO-CHEAT identified hypoglycaemia patterns in all patients. Dexcom Clarity identified no patterns. Predictions from Facebook Prophet were inconsistent and difficult to interpret. Importantly, the patterns identified by HYPO-CHEAT matched the lived experience of all patients, generating new and actionable understanding of the cause of hypos. This facilitated patients to significantly reduce their time in hypoglycaemia from 7.1% to 5.4% even when real-time CGM data was removed. Conclusions HYPO-CHEAT's personalised hypoglycaemia heatmaps reduced total and targeted TBR even when CGM was reblinded. HYPO-CHEAT offers a highly effective and immediately available personalised approach to prevent hypoglycaemia and empower patients to self-care.
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Affiliation(s)
- Chris Worth
- Department of Computer Science, University of Manchester, Manchester, UK
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
| | - Paul W Nutter
- Department of Computer Science, University of Manchester, Manchester, UK
| | - Mark J Dunne
- Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Maria Salomon-Estebanez
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
| | - Indraneel Banerjee
- Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK
- Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Simon Harper
- Department of Computer Science, University of Manchester, Manchester, UK
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Xie X, Guo J, Bremner KE, Wang M, Shah BR, Volodin A. Review and estimation of disutility for joint health states of severe and nonsevere hypoglycemic events in diabetes. J Comp Eff Res 2021; 10:961-974. [PMID: 34287017 DOI: 10.2217/cer-2021-0059] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/17/2023] Open
Abstract
Aim: Many economic evaluations used linear or log-transformed additive methods to estimate the disutility of hypoglycemic events in diabetes, both nonsevere (NSHEs) and severe (SHEs). Methods: We conducted a literature search for studies of disutility for hypoglycemia. We used additive, minimum and multiplicative methods, and the adjusted decrement estimator to estimate the disutilities of joint health states with both NSHEs and SHEs in six scenarios. Results: Twenty-four studies reported disutilities for hypoglycemia in diabetes. Based on construct validity, the adjusted decrement estimator method likely provides less biased estimates, predicting that when SHEs occur, the additional impact from NSHEs is marginal. Conclusion: Our proposed new method provides a different perspective on the estimation of quality-adjusted life-years in economic evaluations of hypoglycemic treatments.
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Affiliation(s)
- Xuanqian Xie
- Health Technology Assessment Program, Ontario Health, Toronto, ON M5S 1N5, Canada
| | - Jennifer Guo
- Health Technology Assessment Program, Ontario Health, Toronto, ON M5S 1N5, Canada
| | - Karen E Bremner
- Toronto General Hospital Research Institute, University Health Network, Toronto, ON M5G 2C4, Canada
| | - Myra Wang
- Health Technology Assessment Program, Ontario Health, Toronto, ON M5S 1N5, Canada
| | - Baiju R Shah
- Division of Endocrinology, Sunnybrook Health Sciences Centre, Toronto, ON M4N 3M5, Canada.,Department of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada
| | - Andrei Volodin
- Department of Mathematics & Statistics, University of Regina, Regina, SK S4S 0A2, Canada
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Carlton J, Leaviss J, Pouwer F, Hendrieckx C, Broadley MM, Clowes M, McCrimmon RJ, Heller SR, Speight J. The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods. Diabetologia 2021; 64:1213-1225. [PMID: 33528625 PMCID: PMC8099839 DOI: 10.1007/s00125-021-05382-x] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2020] [Accepted: 11/19/2020] [Indexed: 11/26/2022]
Abstract
AIMS/HYPOTHESIS It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties. METHODS Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM's content validity included reviewer ratings (N = 16) of relevance, comprehensiveness and comprehensibility: by researchers (n = 6); clinicians (n = 6); and adults with diabetes (n = 4). RESULTS Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), seven hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; and the QoLHYPO questionnaire. Content validity was rated as 'inconsistent', with most as '(very) low' quality, while structural validity was deemed 'unsatisfactory'. Other measurement properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a 'gold standard' measure of the impact of hypoglycaemia on QoL against which to compare the PROMS. CONCLUSIONS/INTERPRETATION None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfactory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL. PROSPERO REGISTRATION CRD42019125153.
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Affiliation(s)
- Jill Carlton
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
| | - Joanna Leaviss
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
| | - Frans Pouwer
- Department of Psychology, University of Southern Denmark, Odense, Denmark
- School of Psychology, Deakin University, Geelong, VIC, Australia
- Steno Diabetes Center Odense, Odense, Denmark
| | - Christel Hendrieckx
- School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes (ACBRD), Melbourne, VIC, Australia
| | - Melanie M Broadley
- Department of Psychology, University of Southern Denmark, Odense, Denmark
| | - Mark Clowes
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
| | | | - Simon R Heller
- Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK
| | - Jane Speight
- Department of Psychology, University of Southern Denmark, Odense, Denmark
- School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes (ACBRD), Melbourne, VIC, Australia
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Alwafi H, Alsharif AA, Wei L, Langan D, Naser AY, Mongkhon P, Bell JS, Ilomaki J, Al Metwazi MS, Man KKC, Fang G, Wong ICK. Incidence and prevalence of hypoglycaemia in type 1 and type 2 diabetes individuals: A systematic review and meta-analysis. Diabetes Res Clin Pract 2020; 170:108522. [PMID: 33096187 DOI: 10.1016/j.diabres.2020.108522] [Citation(s) in RCA: 21] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/04/2020] [Revised: 09/30/2020] [Accepted: 10/13/2020] [Indexed: 12/16/2022]
Abstract
BACKGROUND Previous meta-analysis investigating the incidence and prevalence of hypoglycaemia in both types of diabetes is limited. The purpose of this review is to conduct a systematic review and meta-analysis of the existing literature which investigates the incidence and prevalence of hypoglycaemia in individuals with diabetes. METHODS PubMed, Embase and Cochrane library databases were searched up to October 2018. Observational studies including individuals with diabetes of all ages and reporting incidence and/or prevalence of hypoglycaemia were included. Two reviewers independently screened articles, extracted data and assessed the quality of included studies. Meta-analysis was performed using a random effects model with 95% confidence interval (CI) to estimate the pooled incidence and prevalence of hypoglycaemia in individuals with diabetes. RESULTS Our search strategy generated 35,007 articles, of which 72 studies matched the inclusion criteria and were included in the meta-analysis. The prevalence of hypoglycaemia ranged from 0.074% to 73.0%, comprising a total of 2,462,810 individuals with diabetes. The incidence rate of hypoglycaemia ranged from 0.072 to 42,890 episodes per 1,000 person-years: stratified by type of diabetes, it ranged from 14.5 to 42,890 episodes per 1,000 person-years and from 0.072 to 16,360 episodes per 1,000-person years in type 1 and type 2 diabetes, respectively. CONCLUSION Hypoglycaemia is very common among individuals with diabetes. Further studies are needed to investigate hypoglycaemia-associated risk factors.
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Affiliation(s)
- Hassan Alwafi
- Research Department of Practice and Policy, School of Pharmacy, University College London (UCL), London, United Kingdom; Faculty of Medicine, Umm Al Qura University, Mecca, Saudi Arabia
| | - Alaa A Alsharif
- Department of Pharmacy Practice, Faculty of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia
| | - Li Wei
- Research Department of Practice and Policy, School of Pharmacy, University College London (UCL), London, United Kingdom
| | - Dean Langan
- UCL Great Ormond Street Institute of Child Health, London, United Kingdom
| | | | - Pajaree Mongkhon
- Department of Pharmacy Practice School of Pharmaceutical Sciences, University of Phayao, Phayao, Thailand; Pharmacoepidemiology and Statistics Research Center (PESRC), Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand
| | - J Simon Bell
- Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia
| | - Jenni Ilomaki
- Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia
| | - Mansour S Al Metwazi
- Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
| | - Kenneth K C Man
- Research Department of Practice and Policy, School of Pharmacy, University College London (UCL), London, United Kingdom; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong
| | - Gang Fang
- Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
| | - Ian C K Wong
- Research Department of Practice and Policy, School of Pharmacy, University College London (UCL), London, United Kingdom; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong; The University of Hong Kong - Shenzhen Hospital, 1, Haiyuan 1st Road, Futian District, Shenzhen, Guangdong, China.
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11
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Jendle J, Ericsson Å, Ekman B, Sjöberg S, Gundgaard J, da Rocha Fernandes J, Mårdby AC, Hunt B, Malkin SJP, Thunander M. Real-world cost-effectiveness of insulin degludec in type 1 and type 2 diabetes mellitus from a Swedish 1-year and long-term perspective. J Med Econ 2020; 23:1311-1320. [PMID: 32746676 DOI: 10.1080/13696998.2020.1805454] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS The ReFLeCT study demonstrated that switching to insulin degludec from other basal insulins was associated with reductions in glycated hemoglobin and hypoglycemic events in type 1 (T1D) and type 2 diabetes (T2D), and reductions in insulin doses in T1D. The aim of the present analysis was to assess the short- and long-term cost-effectiveness of switching to insulin degludec in Sweden. METHODS Short-term outcomes were evaluated over 1 year in a Microsoft Excel model, while long-term outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Cohort characteristics and treatment effects were sourced from the ReFLeCT study. Costs (in 2018 Swedish krona [SEK]) encompassed direct medical expenditure and indirect costs from loss of workplace productivity. In the long-term analyses, patients were assumed to receive insulin degludec or continue prior insulin therapy (primarily insulin glargine U100) for 5 years, before all patients intensified to once-daily degludec and mealtime aspart. RESULTS Switching to insulin degludec was associated with improved quality-adjusted life expectancy of 0.04 and 0.02 quality-adjusted life years (QALYs) over 1 year, and 0.16 and 0.08 QALYs over patient lifetimes, in T1D and T2D. Combined costs in T1D and T2D were estimated to be SEK 1,249 lower and SEK 1,181 higher over the short-term, and SEK 157,258 and SEK 2,114 lower over the long-term. Benefits were due to lower insulin doses in T1D, reduced rates of hypoglycemia, and lower incidences of diabetes-related complications. Insulin degludec was associated with an incremental cost-effectiveness ratio of SEK 64,298 per QALY gained for T2D over 1 year and considered dominant for T1D and T2D in all other comparisons. CONCLUSIONS Insulin degludec was projected to be cost-effective or dominant versus other basal insulins for the treatment of T1D and T2D in Sweden.
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Affiliation(s)
- Johan Jendle
- Institute of Medical Sciences, Örebro University, Örebro, Sweden
| | | | - Bertil Ekman
- Department of Endocrinology, and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
| | - Stefan Sjöberg
- Department of Medicine, Karolinska Huddinge University Hospital, Stockholm, Sweden
| | | | | | | | - Barnaby Hunt
- Ossian Health Economics and Communications, Basel, Switzerland
| | | | - Maria Thunander
- Department of Clinical Sciences, Endocrinology and Diabetes, Lund University, Lund, Sweden
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12
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Samya V, Shriraam V, Jasmine A, Akila GV, Anitha Rani M, Durai V, Gayathri T, Mahadevan S. Prevalence of Hypoglycemia Among Patients With Type 2 Diabetes Mellitus in a Rural Health Center in South India. J Prim Care Community Health 2020; 10:2150132719880638. [PMID: 31631765 PMCID: PMC6804359 DOI: 10.1177/2150132719880638] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
Introduction: One of the greatest threats to achieving tight glycemic control is hypoglycemia, which can lead to decreased drug compliance, cardiovascular events, and even mortality. There is lack of literature on this complication in the Indian setting. This study will aid the primary care physician to achieve better glycemic control of the diabetic patients and provide patient education to prevent hypoglycemia. Materials and Methods: It was a cross-sectional study in which 390 patients with type 2 diabetes mellitus getting treated in a primary health center were assessed for symptoms of hypoglycemia. Results: Prevalence of hypoglycemia was 57.44% (95% CI 52.48-62.25). Severe hypoglycemia was found in 10.7% of the patients. The first reported symptom of hypoglycemia was dizziness (72.3%). The most common etiological factor leading to hypoglycemia was missing a meal (89.3%). Females were at a significant higher risk of developing hypoglycemia (OR 1.2, 95% CI 1.04-1.3, P < .05). Conclusion: This study has established the high prevalence of self-reported hypoglycaemia in the rural settings where resources are limited to monitor the glucose levels. The high prevalence urges the need for the primary care physicians to enquire about the hypoglycemic symptoms to all diabetic patients at each visit. It is also important to educate these patients about the symptoms of hypoglycemia and the importance of reporting of such symptoms, which will help in adjusting dose and preventing future attacks.
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Affiliation(s)
- V Samya
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - Vanishree Shriraam
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - Aliya Jasmine
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - G V Akila
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - M Anitha Rani
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - Vanitha Durai
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - T Gayathri
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
| | - Shriraam Mahadevan
- Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
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Hypoglycemia. Endocrinology 2020. [PMID: 31968189 DOI: 10.1007/978-3-030-36694-0_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
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Li X, Yu S, Zhang Z, Radican L, Cummins J, Engel SS, Iglay K, Duke J, Baker J, Brodovicz KG, Naik RG, Leventhal J, Chatterjee AK, Rajpathak S, Weiner M. Predictive modeling of hypoglycemia for clinical decision support in evaluating outpatients with diabetes mellitus. Curr Med Res Opin 2019; 35:1885-1891. [PMID: 31234649 DOI: 10.1080/03007995.2019.1636016] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
Objective: Hypoglycemia occurs in 20-60% of patients with diabetes mellitus. Identifying at-risk patients can facilitate interventions to lower risk. We sought to develop a hypoglycemia prediction model. Methods: In this retrospective cohort study, urban adults prescribed a diabetes drug between 2004 and 2013 were identified. Demographic and clinical data were extracted from an electronic medical record (EMR). Laboratory tests, diagnostic codes and natural language processing (NLP) identified hypoglycemia. We compared multiple logistic regression, classification and regression trees (CART), and random forest. Models were evaluated on an independent test set or through cross-validation. Results: The 38,780 patients had mean age 57 years; 56% were female, 40% African-American and 39% uninsured. Hypoglycemia occurred in 8128 (539 identified only by NLP). In logistic regression, factors positively associated with hypoglycemia included infection, non-long-acting insulin, dementia and recent hypoglycemia. Negatively associated factors included long-acting insulin plus sulfonylurea, and age 75 or older. The models' area under curve was similar (logistic regression, 89%; CART, 88%; random forest, 90%, with ten-fold cross-validation). Conclusions: NLP improved identification of hypoglycemia. Non-long-acting insulin was an important risk factor. Decreased risk with age may reflect treatment or diminished awareness of hypoglycemia. More complex models did not improve prediction.
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Affiliation(s)
- Xiaochun Li
- Indiana University , Indianapolis , IN , USA
| | | | - Zuoyi Zhang
- Regenstrief Institute Inc. , Indianapolis , IN , USA
| | | | | | | | | | - Jon Duke
- Indiana University , Indianapolis , IN , USA
- Regenstrief Institute Inc. , Indianapolis , IN , USA
| | - Jarod Baker
- Regenstrief Institute Inc. , Indianapolis , IN , USA
| | | | | | | | | | | | - Michael Weiner
- Indiana University , Indianapolis , IN , USA
- Regenstrief Institute Inc. , Indianapolis , IN , USA
- Department of Veterans Affairs, Richard L. Roudebush VA Medical Center , Indianapolis , IN , USA
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15
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Brown JB, Reichert SM, Valliere Y, Webster-Bogaert S, Ratzki-Leewing A, Ryan BL, Harris SB. Living With Hypoglycemia: An Exploration of Patients' Emotions: Qualitative Findings From the InHypo-DM Study, Canada. Diabetes Spectr 2019; 32:270-276. [PMID: 31462884 PMCID: PMC6695265 DOI: 10.2337/ds18-0074] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
Hypoglycemia is one of the most common adverse events for people living with type 1 or type 2 diabetes. To gain a deeper understanding of patients' emotions regarding hypoglycemia, we conducted a descriptive qualitative study. Purposive sampling was used to recruit participants for a 30- to 45-minute semi-structured interview. The 16 participants included both women and men with either type 1 or type 2 diabetes, with a mean age of 53 years and mean time since diagnosis of 21 years. All participants had experienced more than one hypoglycemia event in the past year, ranging from nonsevere to severe. Data collection and analysis occurred in an iterative manner. Individual and team analyses of interviews were conducted to identify overarching themes and sub-themes. Thematic analysis revealed the unique interconnection among the emotions experienced by participants, including fear, anxiety, frustration, confidence, and hope. Time, experience, and reflection helped to build participants' confidence in their ability to manage a hypoglycemia event. Patients' emotions regarding hypoglycemia provide valuable insights into life with diabetes. Although hypoglycemia continues to evoke feelings of fear and anxiety, the role of hope may temper these emotions. Understanding the complex interplay of emotions concerning hypoglycemia can guide health care providers in improving clinical practice and promoting patient-centered interventions. Ultimately, health care providers can build patients' hypoglycemia-related confidence by using a strengths-based approach.
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Affiliation(s)
- Judith Belle Brown
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
- School of Social Work, King’s University College, Western University, London, Ontario, Canada
| | - Sonja M. Reichert
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
| | - Yashoda Valliere
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
| | - Susan Webster-Bogaert
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
| | - Alexandria Ratzki-Leewing
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
| | - Bridget L. Ryan
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
| | - Stewart B. Harris
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
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Rossi MC, Nicolucci A, Ozzello A, Gentile S, Aglialoro A, Chiambretti A, Baccetti F, Gentile FM, Romeo F, Lucisano G, Giorda CB. Impact of severe and symptomatic hypoglycemia on quality of life and fear of hypoglycemia in type 1 and type 2 diabetes. Results of the Hypos-1 observational study. Nutr Metab Cardiovasc Dis 2019; 29:736-743. [PMID: 31153746 DOI: 10.1016/j.numecd.2019.04.009] [Citation(s) in RCA: 70] [Impact Index Per Article: 11.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2018] [Revised: 04/04/2019] [Accepted: 04/25/2019] [Indexed: 02/07/2023]
Abstract
BACKGROUND AND AIMS Hypoglycemia represents a relevant burden in people with diabetes. Consequences of hypoglycemia/fear of hypoglycemia on quality of life (QoL) and behaviors of patients with T1DM and T2DM were assessed. METHODS AND RESULTS HYPOS-1 was an observational retrospective study. Fear of hypoglycemia (Fear of Hypoglycemia Questionnaire, FHQ), general health status (visual analog scale of EuroQol questionnaire, EQ5D-VAS) psychological well-being (WHO-5 well being index, WHO-5), diabetes related distress (Problem Areas in Diabetes 5, PAID-5), and corrective/preventive behaviors following hypoglycemia were compared between people with and without previous experience of severe and symptomatic hypoglycemia and by tertiles of FHQ scores. A multivariate analysis was performed to identify factors associated with the likelihood of being in the third tertile of FHQ score. Overall, 2229 patients were involved. Severe hypoglycemia had statistically significant and clinically relevant (measured as effect sizes) negative impact on EQ5D-VAS, WHO-5, PAID-5, and FHQ both in T1DM and T2DM. In T2DM, symptomatic episodes had similar impact of severe hypoglycemia. Moving from the first to the third FHQ tertile, lower scores of EQ-5D VAS and WHO-5, and higher levels of PAID-5 were found. Patients in the third tertile performed more frequently corrective/preventive actions that negatively impact on metabolic control. Previous hypoglycemia, insulin treatment, female gender, age, and school education were the independent factors associated with increased likelihood to be in the third tertile. CONCLUSION Not only severe but also symptomatic hypoglycemia negatively affect patient QoL, especially in T2DM. Addressing fear of hypoglycemia should be a goal of diabetes education.
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Affiliation(s)
- Maria Chiara Rossi
- CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
| | - Antonio Nicolucci
- CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy
| | - Alessandro Ozzello
- Departmental Service of Diabetology and Metabolic Diseases, ASL TO3, Pinerolo, TO, Italy
| | - Sandro Gentile
- Campania University "Luigi Vanvitelli", Naples, Italy; Nefrocenter Research Network, Naples, Italy
| | | | | | - Fabio Baccetti
- Metabolism and Diabetes Unit, ASL 1, Massa, Carrara, Italy
| | | | | | - Giuseppe Lucisano
- CORESEARCH - Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy
| | - Carlo B Giorda
- Metabolism and Diabetes Unit, ASL TO5, Chieri, TO, Italy
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Prevalence of Hypoglycemia, Treatment Satisfaction, Adherence and Their Associations with Glycemic Goals in Patients with Type 2 Diabetes Mellitus Treated with Sulfonylureas: Findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) in Romania. ROMANIAN JOURNAL OF DIABETES NUTRITION AND METABOLIC DISEASES 2019. [DOI: 10.2478/rjdnmd-2019-0006] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Abstract
Background and aims: The aim of this study was to assess the prevalence and evaluate the impact on several treatment and quality of life parameters of hypoglycemia in type 2 diabetes mellitus patients treated with sulfonylureas (SU) in Romania. Secondary objective was to determine the proportion of patients attaining haemoglobin A1c (HbA1c) target of <7%.
Material and method: This was a multi-center, observational study using retrospective clinical chart and laboratory parameters review, and a cross-sectional survey in Romania. The sample in this study consisted of 385 patients. Socio-demographic and clinical variables were compared between patients with inadequate and adequate control.
Results: The mean age of all enrolled subjects was 65.37 (33-87) years. The average BMI was 30.44 kg/m2. Mean diabetes duration was 7.76 (6 months -32) years with the mean age of diabetes at diagnosis of 57.75 (31-85) years. HbA1c was recorded for 238 subjects with mean value of 7.12 (4.8-10.97) %.
Conclusions: The prevalence of hypoglycaemia in SU treated patients was 42.2%. Highest prevalence was in the 50-60 age category, at 49.2% and lowest among the eldest subjects (>70 years), at 38.6%. Prevalence of patients at the goal of HbA1c<7% was 50.8 %. Patients with adequate glycaemic control had more acceptable BMI than those with inadequate glycaemic control. In patients not achieving a goal of HbA1c < 7%, higher level of plasma glucose and total cholesterol was determined compared to those with adequate glycaemic control. There were no significant differences in the HDL-C, triglycerides or albumin:creatinine ratios in patients with both adequate and inadequate glycaemic control.
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18
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Hypoglycemia. Endocrinology 2019. [DOI: 10.1007/978-3-319-27316-7_22-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
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Prevalence of hypoglycemia among a sample of sulfonylurea-treated patients with Type 2 diabetes mellitus in Argentina: The real-life effectiveness and care patterns of diabetes management (RECAP-DM) study. ENDOCRINOL DIAB NUTR 2018; 65:592-602. [DOI: 10.1016/j.endinu.2018.05.014] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/26/2017] [Revised: 05/17/2018] [Accepted: 05/22/2018] [Indexed: 02/06/2023]
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Jing X, Chen J, Dong Y, Han D, Zhao H, Wang X, Gao F, Li C, Cui Z, Liu Y, Ma J. Related factors of quality of life of type 2 diabetes patients: a systematic review and meta-analysis. Health Qual Life Outcomes 2018; 16:189. [PMID: 30231882 PMCID: PMC6147036 DOI: 10.1186/s12955-018-1021-9] [Citation(s) in RCA: 179] [Impact Index Per Article: 25.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2017] [Accepted: 09/13/2018] [Indexed: 01/03/2023] Open
Abstract
BACKGROUND Diabetes is a chronic disease, and it could affect both health and quality of life (QOL). A lot of studies have reported some predictors of QOL of type 2 diabetes patients. While their results were not completely consistent. So the aim of our study was finding out the related factors (including characteristics related to the disease, life styles and mental health factors) of QOL of type 2 diabetes patients. METHODS We searched Cochrane library, EmBase, PubMed and CNKI databases for published studies that evaluated the related factors of QOL of type 2 diabetes patients by using a proper statistic method and had effect sizes (OR or β) and 95% confidence intervals from January 1st 2000 to May 31st 2016. Any study types were acceptable, and we excluded the reviews, letters, editorials and pooled analyses. The data were analyzed using STATA software (Version 12.0; Stata Corporation). Effect sizes and 95% confidence intervals were calculated to evaluate the relationship between these factors and QOL. RESULTS Eighteen studies were included into our systematic review and meta-analysis, totaling 57,109 type 2 diabetes patients. Do more physical exercises (The pooled ORs ranged from 0.635 to 0.825 for different scales, less than 1.00), glucose check more frequently [pooled OR (95%CI): 0.175 (0.041, 0.756)] were associated with a better QOL. Presence of complications (The pooled ORs ranged from 1.462 to 3.038 for different scales, more than 1.00), presence of hypertension [pooled OR (95%CI): 1.389 (1.173, 1644)], longer duration of diabetes [pooled OR (95%CI): 1.865 (1.088, 3.197)], diet with more red meat [pooled OR (95%CI): 2.085 (1.063, 4.089)] and depression (The pooled ORs ranged from 3.003 to 11.473 for different scales, higher than 1.00) were associated with a worse QOL. CONCLUSION The results of this study show that physical exercise, glucose check frequently, complications, hypertension, duration of diabetes, diet with more red meat, and depression were associated with the QOL of type 2 diabetes patients.
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Affiliation(s)
- Xiyue Jing
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Jiageng Chen
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Yanan Dong
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Duolan Han
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Haozuo Zhao
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Xuying Wang
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Fei Gao
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Changping Li
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Zhuang Cui
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Yuanyuan Liu
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
| | - Jun Ma
- Department of Health Statistics, College of Public Health, Tianjin Medical University, No. 22 Qixiangtai Road, Heping District, Tianjin, 300070 People’s Republic of China
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Ahammed A, Pathan F, Afsana F, Ahammed I, Mir AS, Yusuf A. The Burden of Severe Hypoglycemia on Quality of Life among Diabetes Mellitus Patients in a Tertiary Level Hospital of Bangladesh. Indian J Endocrinol Metab 2018; 22:499-504. [PMID: 30148097 PMCID: PMC6085957 DOI: 10.4103/ijem.ijem_338_17] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
OBJECTIVE This study aimed to determine the impact of hypoglycemia on health-related quality of life from a patient perspective. MATERIALS AND METHODS A cross-sectional study was conducted in 164 type 2 diabetes patients admitted due to severe hypoglycemia from August 2015 to October 2016 at Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders, in Dhaka. Impact of severe hypoglycemia on health-related quality of life in diabetic patients was evaluated using the disease-specific questionnaire audit of diabetes-dependent quality of life-19 (ADDQOL-19). RESULTS The median ADDQOL score was calculated at -3.31. Totally, 88 (53.7%) patients reported an ADDQOL score of - 3.31 or more, and 76 (46.3%) patients had an ADDQOL score of less than -3.31 (lower quality of life [QoL]). After considering weighting, "Freedom to eat" (mean Weighted Impact Score-6.32 ± 1.94) was the most and "Holidays" (mean Weighted Impact Score-0.96 ± 0.19) was the least affected QoL domains, respectively. In multivariate logistic regression analysis, severe hypoglycemia impact on ADDQOL was related with age (odds ratio [OR] 0.932, 95% confidence intervals [CIs] 0.897-0.969, P < 0.001), sex (OR 0.088, 95% CIs 0.023-0.338, P < 0.001), glycated hemoglobin (%) (OR 0.613, 95% CIs 0.422-0.890, P = 0.010), and marital status (OR 9.264, 95% CIs 2.467-34.790, P = 0.001). CONCLUSIONS The results of this analysis suggest hypoglycemia impacts heavily on the well-being and quality of life of people with diabetes, and every effort should be made to minimize hypoglycemia while aiming for good glycemic control.
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Affiliation(s)
- Afsar Ahammed
- Department of Physiotherapy, National Institute of Traumatology and Orthopedic Rehabilitation, Dhaka, Bangladesh
| | - Faruque Pathan
- Department of Endocrinology, Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders, Dhaka, Bangladesh
| | - Faria Afsana
- Department of Endocrinology, Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders, Dhaka, Bangladesh
| | - Imran Ahammed
- Officer on Special Duty, Ministry of Health and Family Welfare, Dhaka, Bangladesh
| | - Ahmed Salam Mir
- Department of Endocrinology, Dhaka Central International Medical College and Hospital, Dhaka, Bangladesh
| | - Abdullah Yusuf
- Department of Microbiology, National Institute of Neurosciences and Hospital, Dhaka, Bangladesh
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Pettus J, Santos Cavaiola T, Edelman SV. Recommendations for Initiating Use of Afrezza Inhaled Insulin in Individuals with Type 1 Diabetes. Diabetes Technol Ther 2018; 20:448-451. [PMID: 29901406 DOI: 10.1089/dia.2017.0463] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
Treatment with Afrezza® (insulin human) inhalation powder in individuals with type 1 diabetes (T1D) reduces HbA1c levels similar to rapid-acting insulin analogs, but with significantly less hypoglycemia due to its unique time action profile. Examinations of studies of Afrezza pharmacokinetics/pharmacodynamics, relevant clinical trials, and U.S. Food and Drug Administration (FDA) documentation suggest that current FDA-mandated dosing recommendations for initiating Afrezza treatment may not result in optimal glycemic control for individuals with T1D. Recommendations for initiating Afrezza insulin therapy in T1D patients are presented in this article.
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Affiliation(s)
- Jeremy Pettus
- 1 Department of Medicine, Clinical and Translational Research Institute (CTRI), University of California San Diego , San Diego, California
| | - Tricia Santos Cavaiola
- 1 Department of Medicine, Clinical and Translational Research Institute (CTRI), University of California San Diego , San Diego, California
| | - Steven V Edelman
- 1 Department of Medicine, Clinical and Translational Research Institute (CTRI), University of California San Diego , San Diego, California
- 2 University of California San Diego and Taking Control of Your Diabetes 501c3 , San Diego, California
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Ratzki-Leewing A, Harris SB, Mequanint S, Reichert SM, Belle Brown J, Black JE, Ryan BL. Real-world crude incidence of hypoglycemia in adults with diabetes: Results of the InHypo-DM Study, Canada. BMJ Open Diabetes Res Care 2018; 6:e000503. [PMID: 29713480 PMCID: PMC5922478 DOI: 10.1136/bmjdrc-2017-000503] [Citation(s) in RCA: 65] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/06/2017] [Revised: 02/23/2018] [Accepted: 03/10/2018] [Indexed: 01/16/2023] Open
Abstract
OBJECTIVE Very few real-world studies have been conducted to assess the incidence of diabetes-related hypoglycemia. Moreover, there is a paucity of studies that have investigated hypoglycemia among people taking secretagogues as a monotherapy or in combination with insulin. Accordingly, our research team developed and validated the InHypo-DM Person with Diabetes Mellitus Questionnaire (InHypo-DMPQ) with the aim of capturing the real-world incidence of self-reported, symptomatic hypoglycemia. The questionnaire was administered online to a national sample of Canadians (≥18 years old) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) treated with insulin and/or insulin secretagogues. RESEARCH DESIGN AND METHODS Self-report data obtained from the InHypo-DMPQ were descriptively analyzed to ascertain the crude incidence proportions and annualized incidence densities (rates) of 30-day retrospective non-severe and 1-year retrospective severe hypoglycemia, including daytime and nocturnal events. RESULTS A total of 552 people (T2DM: 83%; T1DM: 17%) completed the questionnaire. Over half (65.2%) of the total respondents reported experiencing at least one event (non-severe or severe) at an annualized crude incidence density of 35.1 events per person-year. The incidence proportion and rate of non-severe events were higher among people with T1DM versus T2DM (77% and 55.7 events per person-year vs 54% and 28.0 events per person-year). Severe hypoglycemia was reported by 41.8% of all respondents, at an average rate of 2.5 events per person-year. CONCLUSIONS The results of the InHypo-DMPQ, the largest real-world investigation of hypoglycemia epidemiology in Canada, suggest that the incidence of hypoglycemia among adults with diabetes taking insulin and/or insulin secretagogues is higher than previously thought.
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Affiliation(s)
- Alexandria Ratzki-Leewing
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Stewart B Harris
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Selam Mequanint
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Sonja M Reichert
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Judith Belle Brown
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Jason Edward Black
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Bridget L Ryan
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
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Heinemann L, Parkin CG. Rethinking the Viability and Utility of Inhaled Insulin in Clinical Practice. J Diabetes Res 2018; 2018:4568903. [PMID: 29707584 PMCID: PMC5863311 DOI: 10.1155/2018/4568903] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2017] [Revised: 12/21/2017] [Accepted: 01/23/2018] [Indexed: 01/01/2023] Open
Abstract
Despite considerable advances in pharmacotherapy and self-monitoring technologies in the last decades, a large percentage of adults with diabetes remain unsuccessful in achieving optimal glucose due to suboptimal medication adherence. Contributors to suboptimal adherence to insulin treatment include pain, inconvenience, and regimen complexity; however, a key driver is hypoglycemia. Improvements in the PK/PD characteristics of today's SC insulins provide more physiologic coverage of basal and prandial insulin requirements than regular human insulin; however, they do not achieve the rapid on/rapid off characteristics of endogenously secreted insulin seen in healthy, nondiabetic individuals. Pulmonary administration of prandial insulin represents an attractive option that overcomes limitations of SC insulin by providing more a rapid onset of action and a faster return of action to baseline levels than SC administration of rapid-acting insulin analogs. This article reviews the unique PK/PD properties of a novel inhaled formulation that support its use in patient populations with T1D or T2D.
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Hypoglycemia. Endocrinology 2018. [DOI: 10.1007/978-3-319-27316-7_22-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
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Pollock RF, Chubb B, Valentine WJ, Heller S. Evaluating the cost-effectiveness of insulin detemir versus neutral protamine Hagedorn insulin in patients with type 1 or type 2 diabetes in the UK using a short-term modeling approach. Diabetes Metab Syndr Obes 2018; 11:217-226. [PMID: 29844693 PMCID: PMC5962301 DOI: 10.2147/dmso.s156739] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/05/2022] Open
Abstract
BACKGROUND To estimate the short-term cost-effectiveness of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin based on the incidence of non-severe hypoglycemia and changes in body weight in subjects with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the UK. METHODS A model was developed to evaluate cost-effectiveness based on non-severe hypoglycemia, body mass index, and pharmacy costs over 1 year. Published rates of non-severe hypoglycemia were employed in the T1D and T2D analyses, while reduced weight gain with IDet was modeled in the T2D analysis only. Effectiveness was calculated in terms of quality-adjusted life expectancy using published utility scores. Pharmacy costs were captured using published prices and defined daily doses. Costs were expressed in 2016 pounds sterling (GBP). Sensitivity analyses were performed (including probabilistic sensitivity analysis). RESULTS In T1D, IDet was associated with fewer non-severe hypoglycemic events than NPH insulin (126.7 versus 150.8 events per person-year), leading to an improvement of 0.099 quality-adjusted life years (QALYs). Costs with IDet were GBP 60 higher, yielding an incremental cost-effectiveness ratio (ICER) of GBP 610 per QALY gained. In T2D, mean non-severe hypoglycemic event rates and body weight were lower with IDet than NPH insulin, leading to a total incremental utility of 0.120, accompanied by an annual cost increase of GBP 171, yielding an ICER of GBP 1,422 per QALY gained for IDet versus NPH insulin. CONCLUSION Short-term health economic evaluation showed IDet to be a cost-effective alternative to NPH insulin in the UK due to lower rates of non-severe hypoglycemia (T1D and T2D) and reduced weight gain (T2D only).
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Affiliation(s)
- Richard F Pollock
- Health Economics and Outcomes Research, Ossian Health Economics and Communications GmbH, Basel, Switzerland
- Correspondence: Richard F Pollock, Ossian Health Economics and Communications GmbH, Bäumleingasse 20, 4051 Basel, Switzerland, Tel +41 61 271 6214, Email
| | | | - William J Valentine
- Health Economics and Outcomes Research, Ossian Health Economics and Communications GmbH, Basel, Switzerland
| | - Simon Heller
- Department of Oncology & Metabolism, The University of Sheffield, Sheffield, UK
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Pettus J, Edelman SV. Recommendations for Using Real-Time Continuous Glucose Monitoring (rtCGM) Data for Insulin Adjustments in Type 1 Diabetes. J Diabetes Sci Technol 2017; 11:138-147. [PMID: 27530720 PMCID: PMC5375074 DOI: 10.1177/1932296816663747] [Citation(s) in RCA: 84] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
The clinical benefits of real time continuous glucose monitoring (rtCGM) use have been well demonstrated in both CSII- and MDI-treated individuals in large clinical trials. However, recommendations for patient use of rtCGM in everyday life situations are lacking. This article provides guidance to clinicians and patients with type 1 diabetes (T1D) in effective use of rtCGM data, including glucose rate of change (ROC) arrows, for insulin dosing adjustments and other treatment decisions. The recommendations presented here are based on our own clinical experiences as endocrinologists, our personal experiences living with T1D using rtCGM, and findings from a recent survey of T1D patients who have successfully used rtCGM in their self-management. It is important that both clinicians and people with diabetes understand the utility and limitations of rtCGM. Maintaining a collaborative clinician-user relationship remains an important factor in safe, successful rtCGM use.
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Affiliation(s)
- Jeremy Pettus
- University of California, San Diego, San Diego, CA, USA
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Evans M, Gundgaard J, Hansen BB. Cost-Effectiveness of Insulin Degludec/Insulin Aspart Versus Biphasic Insulin Aspart in Patients with Type 2 Diabetes from a Danish Health-Care Perspective. Diabetes Ther 2016; 7:809-823. [PMID: 27553066 PMCID: PMC5118233 DOI: 10.1007/s13300-016-0195-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/14/2016] [Indexed: 11/13/2022] Open
Abstract
INTRODUCTION To evaluate the cost-effectiveness of the co-formulation insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart (BIAsp 30), both administered twice daily, in patients with type 2 diabetes mellitus (T2DM), using a short-term cost-effectiveness model. METHODS Data from two phase 3a treat-to-target clinical trials were used to populate a simple and transparent short-term cost-effectiveness model. The costs and effects of treatment with IDegAsp versus BIAsp 30 were calculated over a 5-year period, from a Danish health-care cost perspective. One-way and probabilistic sensitivity analyses were conducted to assess the degree of uncertainty and robustness of the results. RESULTS The base-case incremental cost-effectiveness ratio (ICER) of 81,507.91 Danish Kroner (DKK) per quality-adjusted life year (QALY) demonstrates that IDegAsp is a cost-effective treatment compared with BIAsp 30, over a 5-year time horizon. One-way sensitivity analyses show that the ICERs remain within an acceptable range when the rates of hypoglycemia, unit cost of hypoglycemia, disutilities of hypoglycemic events, and the time horizon are varied, ranging from 71,012 DKK to 209,446 DKK. The probabilistic sensitivity analysis demonstrates that the probability that IDegAsp is cost-effective relative to BIAsp 30 is 99.50%, assuming a cost-effectiveness threshold of 250,000 DKK per QALY. CONCLUSION This short-term cost-effectiveness model shows that IDegAsp is a cost-effective treatment compared with BIAsp 30 for patients with T2DM. This result is primarily driven by significant reductions in severe hypoglycemia and insulin dose observed with IDegAsp versus BIAsp 30. Sensitivity analyses demonstrate the robustness of these results. FUNDING Novo Nordisk A/S, Søborg, Denmark.
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Affiliation(s)
- Marc Evans
- University Hospital Llandough, Cardiff, UK.
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Gu S, Zeng Y, Yu D, Hu X, Dong H. Cost-Effectiveness of Saxagliptin versus Acarbose as Second-Line Therapy in Type 2 Diabetes in China. PLoS One 2016; 11:e0167190. [PMID: 27875596 PMCID: PMC5119856 DOI: 10.1371/journal.pone.0167190] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2016] [Accepted: 11/09/2016] [Indexed: 12/16/2022] Open
Abstract
Objective This study assessed the long-term cost-effectiveness of saxagliptin+metformin (SAXA+MET) versus acarbose+metformin (ACAR+MET) in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on MET alone. Methods Systematic literature reviews were performed to identify studies directly comparing SAXA+MET versus ACAR+MET, and to obtain diabetes-related events costs which were modified by hospital surveys. A Cardiff Diabetes Model was used to estimate the long-term economic and health treatment consequences in patients with T2DM. Costs (2014 Chinese yuan) were calculated from the payer’s perspective and estimated over a patient’s lifetime. Results SAXA+MET predicted lower incidences of most cardiovascular events, hypoglycemia events and fatal events, and decreased total costs compared with ACAR+MET. For an individual patient, the quality-adjusted life-years (QALYs) gained with SAXA+MET was 0.48 more than ACAR+MET at a cost saving of ¥18,736, which resulted in a cost saving of ¥38,640 per QALY gained for SAXA+MET versus ACAR+MET. Results were robust across various univariate and probabilistic sensitivity analyses. Conclusion SAXA+MET is a cost-effective treatment alternative compared with ACAR+MET for patients with T2DM in China, with a little QALYs gain and lower costs. SAXA is an effective, well-tolerated drug with a low incidence of adverse events and ease of administration; it is anticipated to be an effective second-line therapy for T2DM treatment.
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Affiliation(s)
- Shuyan Gu
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang Province, China
| | - Yuhang Zeng
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang Province, China
| | - Demin Yu
- Key Laboratory of Hormones and Development (Ministry of Health), Metabolic Diseases Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
| | - Xiaoqian Hu
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang Province, China
| | - Hengjin Dong
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang Province, China
- * E-mail:
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Type 2 Diabetes, Hypoglycemia, and Basal Insulins: Ongoing Challenges. Clin Ther 2016; 39:S1-S11. [PMID: 27871780 DOI: 10.1016/j.clinthera.2016.09.020] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2016] [Revised: 09/25/2016] [Accepted: 09/29/2016] [Indexed: 12/16/2022]
Abstract
Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence and consequences of hypoglycemia in people with type 2 diabetes with a focus on those who use basal insulins, offering strategies for prevention and management. It also discusses the benefits and challenges associated with new basal insulins, and their potential role in reducing hypoglycemia risk.
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Samah S, Neoh CF, Wong YY, Hassali MA, Shafie AA, Lim SM, Ramasamy K, Mat Nasir N, Han YW, Burroughs T. Linguistic and psychometric validation of the Malaysian version of Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI). Res Social Adm Pharm 2016; 13:1135-1141. [PMID: 27825607 DOI: 10.1016/j.sapharm.2016.10.017] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2016] [Revised: 10/18/2016] [Accepted: 10/23/2016] [Indexed: 11/19/2022]
Abstract
BACKGROUND Quality of life (QoL) assessment provides valuable outcome to support clinical decision-making, particularly for patients with chronic diseases that are incurable. A brief, 15-item diabetes-specific tool [i.e. Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI)] is known to be developed in English and validated for use in clinical practice. This simplified tool, however, is not readily available for use in the Malaysian setting. OBJECTIVE To translate the DQoL-BCI into a Malaysian version and to assess its construct validity (factorial validity, convergent validity and discriminant validity), reliability (internal consistency) and floor and ceiling effects among the Malaysian diabetic population. MATERIAL AND METHODS A forward-backward translation, involving professional translators and experts with vast experience in translation of patient reported outcome measures, was conducted. A total of 202 patients with Type 2 diabetes mellitus (T2DM) who fulfilled the inclusion criteria were invited to complete the translated DQoL-BCI. Data were analysed using SPSS for exploratory factor analysis (EFA), convergent and discriminant validity, reliability and test-retest, and AMOS software for confirmatory factor analysis (CFA). RESULTS Findings from EFA indicated that the 4-factor structure of the Malaysian version of DQoL-BCI was optimal and explained 50.9% of the variance; CFA confirmed the 4-factor model fit. There was negative, moderate correlation between the scores of DQoL-BCI (Malaysian version) and EQ-5D-3L utility score (r = -0.329, p = 0.003). Patients with higher glycated haemoglobin levels (p = 0.008), diabetes macrovascular (p = 0.017) and microvascular (p = 0.013) complications reported poorer QoL. Cronbach's alpha coefficient and intraclass coefficient correlations (range) obtained were 0.703 and 0.86 (0.734-0.934), indicating good reliability and stability of the translated DQoL-BCI. CONCLUSION This study had validated the linguistic and psychometric properties of DQoL-BCI (Malaysian version), thus providing a valid and reliable brief tool for assessing the QoL of Malaysian T2DM patients.
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Affiliation(s)
- Syamimi Samah
- Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), 42300, Bandar Puncak Alam, Selangor Darul Ehsan, Malaysia; Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences Community of Research, UiTM, 40450, Shah Alam, Selangor Darul Ehsan, Malaysia
| | - Chin Fen Neoh
- Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), 42300, Bandar Puncak Alam, Selangor Darul Ehsan, Malaysia; Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences Community of Research, UiTM, 40450, Shah Alam, Selangor Darul Ehsan, Malaysia.
| | - Yuet Yen Wong
- Faculty of Pharmacy, UiTM, Bertam Campus, 13200, Kepala Batas, Penang, Malaysia
| | - Mohamed Azmi Hassali
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Penang, Malaysia
| | - Asrul Akmal Shafie
- Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Penang, Malaysia
| | - Siong Meng Lim
- Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), 42300, Bandar Puncak Alam, Selangor Darul Ehsan, Malaysia; Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences Community of Research, UiTM, 40450, Shah Alam, Selangor Darul Ehsan, Malaysia
| | - Kalavathy Ramasamy
- Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), 42300, Bandar Puncak Alam, Selangor Darul Ehsan, Malaysia; Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences Community of Research, UiTM, 40450, Shah Alam, Selangor Darul Ehsan, Malaysia
| | - Nafiza Mat Nasir
- Primary Care Medicine Discipline, Faculty of Medicine, UiTM, Selayang Campus, 68100, Batu Caves, Selangor Darul Ehsan, Malaysia
| | - Yung Wen Han
- Primary Care Medicine Discipline, Faculty of Medicine, UiTM, Selayang Campus, 68100, Batu Caves, Selangor Darul Ehsan, Malaysia
| | - Thomas Burroughs
- Center for Health Outcomes Research (SLUCOR), Saint Louis University, One North Grand, St. Louis, United States
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Gu S, Mu Y, Zhai S, Zeng Y, Zhen X, Dong H. Cost-Effectiveness of Dapagliflozin versus Acarbose as a Monotherapy in Type 2 Diabetes in China. PLoS One 2016; 11:e0165629. [PMID: 27806087 PMCID: PMC5091768 DOI: 10.1371/journal.pone.0165629] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2016] [Accepted: 10/15/2016] [Indexed: 12/30/2022] Open
Abstract
OBJECTIVE To estimate the long-term cost-effectiveness of dapagliflozin versus acarbose as monotherapy in treatment-naïve patients with type 2 diabetes mellitus (T2DM) in China. METHODS The Cardiff Diabetes Model, an economic model designed to evaluate the cost-effectiveness of comparator therapies in diabetes was used to simulate disease progression and estimate the long-term effect of treatments on patients. Systematic literature reviews, hospital surveys, meta-analysis and indirect treatment comparison were conducted to obtain model-required patient profiles, clinical data and costs. Health insurance costs (2015¥) were estimated over 40 years from a healthcare payer perspective. Univariate and probabilistic sensitivity analyses were performed. RESULTS The model predicted that dapagliflozin had lower incidences of cardiovascular events, hypoglycemia and mortality events, was associated with a mean incremental benefit of 0.25 quality-adjusted life-years (QALYs) and with a lower cost of ¥8,439 compared with acarbose. This resulted in a cost saving of ¥33,786 per QALY gained with dapagliflozin. Sensitivity analyses determined that the results are robust. CONCLUSION Dapagliflozin is dominant compared with acarbose as monotherapy for Chinese T2DM patients, with a little QALY gain and lower costs. Dapagliflozin offers a well-tolerated and cost-effective alternative medication for treatment-naive patients in China, and may have a direct impact in reducing the disease burden of T2DM.
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Affiliation(s)
- Shuyan Gu
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang, China
| | - Yiming Mu
- Department of Endocrinology and Metabolism, Chinese PLA General Hospital, Chinese PLA Medical College, Beijing, China
| | - Suodi Zhai
- Department of Pharmacy, Peking University Third Hospital, Beijing, China
| | - Yuhang Zeng
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang, China
| | - Xuemei Zhen
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang, China
| | - Hengjin Dong
- Center for Health Policy Studies, School of Public Health, Zhejiang University School of Medicine, Hangzhou City, Zhejiang, China
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Jakubczyk M, Lipka I, Pawęska J, Niewada M, Rdzanek E, Zaletel J, Ramírez de Arellano A, Doležal T, Chekorova Mitreva B, Nagy B, Petrova G, Šarić T, Yfantopoulos J, Czech M. Cost of severe hypoglycaemia in nine European countries. J Med Econ 2016; 19:973-82. [PMID: 27163169 DOI: 10.1080/13696998.2016.1188823] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
OBJECTIVE Complications contribute largely to the economic gravity of diabetes mellitus (DM). How they arise and are treated differs substantially between countries. This paper assesses the total annual, direct, and indirect cost of severe hypoglycemia events (SHEs) in nine European countries: Bulgaria, Croatia, the Czech Republic, Greece, Hungary, Macedonia/the former Yugoslav Republic of Macedonia (MK), Poland, Slovenia, and Spain. METHODS Data was collected on epidemiology, treatment structure, SHE-driven resource consumption, and unit costs. Two systematic reviews-on the SHE rates and the resources used for treatment-and data on the days-of-work lost due to SHE along with salaries and employment rates were used. The total SHE cost in each country was calculated and how the differences are driven by individual parameters was analysed. RESULTS The annual costs of SHEs varied in absolute terms from €379,951.25 in MK up to €58,429,684.40 in Spain, or-when expressed per one drug-treated DM patient-from €5.47 in Bulgaria up to €17.74 in Spain. Indirect cost constituted between 6.01% (MK) and 26.49% (Hungary) of the total cost. The differences between countries are driven mostly by the cost of treating a single event, and this is related to general differences in prices. LIMITATIONS The main limitation is the lack of good quality data in some parts, and the necessity to use mean-value imputations, experts' opinions, etc. Additionally, we only considered DM treatment as the SHE driver, while other elements, e.g. style of living, may contribute substantially. CONCLUSIONS A common framework can be applied to estimate the economic burden of SHE in various countries, allowing one to identify the drivers of differences in cost. Treating DM is complex, and so no resolute conclusions ought to be drawn as to whether SHE management is better in one country than another.
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Affiliation(s)
- Michał Jakubczyk
- a Decision Analysis and Support Unit, Warsaw School of Economics , Poland
| | - Izabela Lipka
- b HealthQuest spółka z ograniczoną odpowiedzialnością Sp. K , Warsaw , Poland
| | - Justyna Pawęska
- b HealthQuest spółka z ograniczoną odpowiedzialnością Sp. K , Warsaw , Poland
| | - Maciej Niewada
- c Department of Experimental and Clinical Pharmacology , Medical University of Warsaw , Poland
| | - Elżbieta Rdzanek
- b HealthQuest spółka z ograniczoną odpowiedzialnością Sp. K , Warsaw , Poland
| | - Jelka Zaletel
- d Department of Endocrinology, Diabetes and Metabolic Diseases , University Medical Centre , Ljubljana , Slovenia
| | | | - Tomáš Doležal
- f Institute of Health Economics and Technology Assessment , Prague , the Czech Republic
- g Department of Pharmacology, 2nd Faculty of Medicine , Prague , the Czech Republic
| | | | - Bence Nagy
- i Healthware Consulting Ltd , Budapest , Hungary
| | - Guenka Petrova
- j Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy , Medical University of Sofia , Bulgaria
| | - Tereza Šarić
- k Promeritus savjetovanje Ltd. , Zagreb , Croatia
| | - John Yfantopoulos
- l School of Economics and Political Science , University of Athens , Greece
| | - Marcin Czech
- m Department of Pharmacoeconomics , Medical University of Warsaw , Poland
- n Business School, Warsaw University of Technology , Poland
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Rauh SP, Rutters F, Thorsted BL, Wolden ML, Nijpels G, van der Heijden AAWA, Walraven I, Elders PJ, Heymans MW, Dekker JM. Self-reported hypoglycaemia in patients with type 2 diabetes treated with insulin in the Hoorn Diabetes Care System Cohort, the Netherlands: a prospective cohort study. BMJ Open 2016; 6:e012793. [PMID: 27645557 PMCID: PMC5030618 DOI: 10.1136/bmjopen-2016-012793] [Citation(s) in RCA: 7] [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: 01/30/2023] Open
Abstract
BACKGROUND Our aim was to study the prevalence of self-reported hypoglycaemic sensations and its association with mortality in patients with type 2 diabetes (T2D) treated with insulin in usual care. METHODS Demographics, clinical characteristics and mortality data were obtained from 1667 patients with T2D treated with insulin in the Hoorn Diabetes Care System Cohort (DCS), a prospective cohort study using clinical care data. Self-reported hypoglycaemic sensations were defined as either mild: events not requiring help; or severe: events requiring help from others (either medical assistance or assistance of others). The association between hypoglycaemic sensations and mortality was analysed using logistic regression analysis. RESULTS At baseline, 981 patients (59%) reported no hypoglycaemic sensations in the past year, 612 (37%) reported only mild sensations and 74 (4%) reported severe hypoglycaemic sensations. During a median follow-up of 1.9 years, 98 patients (5.9%) died. Reporting only mild hypoglycaemic sensations was associated with a lower mortality risk (OR 0.48, 95% CI 0.28 to 0.80), while reporting severe sensations was not significantly associated with mortality (OR 0.76, 95% CI 0.33 to 1.80), compared with reporting no hypoglycaemic sensations, and adjusting for demographic and clinical characteristics. Sensitivity analyses showed an OR of 1.38 (95% CI 0.31 to 6.11) for patients reporting severe hypoglycaemic sensations requiring medical assistance. CONCLUSIONS Self-reported hypoglycaemic sensations are highly prevalent in our insulin-treated T2D population. Patients reporting hypoglycaemic sensations not requiring medical assistance did not have an increased risk of mortality, suggesting that these sensations are not an indicator of increased short-term mortality risk in patients with T2D.
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Affiliation(s)
- Simone P Rauh
- Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
| | - Femke Rutters
- Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
| | | | | | - Giel Nijpels
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
- Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands
| | - Amber A W A van der Heijden
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
- Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands
| | - Iris Walraven
- Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
| | - Petra J Elders
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
- Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands
| | - Martijn W Heymans
- Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
| | - Jacqueline M Dekker
- Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
- EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
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Frier BM, Jensen MM, Chubb BD. Hypoglycaemia in adults with insulin-treated diabetes in the UK: self-reported frequency and effects. Diabet Med 2016; 33:1125-32. [PMID: 26248501 PMCID: PMC5054881 DOI: 10.1111/dme.12878] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 07/29/2015] [Indexed: 01/26/2023]
Abstract
AIM Few real-life studies of non-severe (self-treated) hypoglycaemic events are available. This survey quantified the self-reported frequency of non-severe hypoglycaemia and its effects in adults with insulin-treated diabetes in the UK. METHODS Adults aged > 15 years with Type 1 diabetes or insulin-treated Type 2 diabetes completed ≤ 4 weekly questionnaires (7-day recall). Respondents with Type 2 diabetes were grouped by insulin regimen: basal-only, basal-bolus and 'other'. RESULTS Overall, 1038 respondents (466 with Type 1 diabetes, 572 with Type 2 diabetes) completed 3528 questionnaires. Mean numbers of non-severe events per week were 2.4 (Type 1 diabetes; median = 2) and 0.8 (Type 2 diabetes; median = 0); 23% and 26% of non-severe events occurred at night, respectively. Fatigue and reduced alertness were the commonest issues following events (78% and 51% of respondents, respectively). The effects of nocturnal events persisted longer than those of daytime events: Type 1 diabetes = 10.6 vs. 4.9 h (P = 0.0002); Type 2 diabetes = 15.3 vs. 5.1 h (P < 0.0001). In the week following an event, respondents' blood glucose measurements increased by 4.3 (Type 1 diabetes; 12% increment) and 4.2 (Type 2 diabetes; 21% increment) tests/week. In employed respondents, 20% of events caused work-time loss, more so following nocturnal (vs. daytime) hypoglycaemia: Type 1 diabetes = 2.7 vs. 1.1 h (P = 0.0184); Type 2 diabetes = 2.5 vs. 1.6 h (P = 0.1340). Most respondents rarely/never informed healthcare professionals about events (Type 1 diabetes = 82%, Type 2 diabetes = 69%). CONCLUSIONS Non-severe hypoglycaemia is common in adults with insulin-treated diabetes in the UK, with consequent health-related/economic effects. Communication about non-severe hypoglycaemia is limited and the burden of hypoglycaemia may be underestimated.
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Affiliation(s)
- B M Frier
- The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK
| | - M M Jensen
- Novo Nordisk Scandinavia AB, Copenhagen, Denmark
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Chandrakumar A, Dilip C, Suriyaprakash TNK, Thomas L, Surendran R. Incidence and risk factors of hypoglycemia among Type 2 diabetic patients in a South Indian hospital. Diabetes Metab Syndr 2016; 10:S22-S25. [PMID: 26806327 DOI: 10.1016/j.dsx.2016.01.014] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2015] [Accepted: 01/09/2016] [Indexed: 02/03/2023]
Abstract
AIM The study was aimed at assessing the cumulative incidence of hypoglycemia and precipitating risk factors among type 2 diabetes mellitus in-patients of a tertiary care hospital in South India. METHODS The prospective cross sectional study spanning 14 months was conducted in a tertiary care hospital in Kerala. All T2DM patients who were administered any form of insulin during the length of hospital stay was monitored for assessing the hypoglycemic episodes. Any patient with a GRBS value less than 70mg/dL was defined to be hypoglycemic as per the ADA guidelines. The statistical analysis of collected data was performed using SPSS 18 for windows version. RESULTS Of the 1650 subjects enrolled in the study, 204 subjects developed hypoglycemia. The sample composed of 60.8% females and 39.2% males and the difference was significant with p=0.02. A significant positive correlation was observed between HbA1c values and GRBS value, with a 2 tailed Pearson correlation coefficient of 0.027. On stratifying as per the modality of insulin dose prescribed, 72.5% of the hypoglycemic patients were found to have been administered fixed dose insulin. CONCLUSION The cumulative incidence of institutional hypoglycemia among type 2 diabetic inpatients was gauged as 12.36%; among which, 26.96% had asymptomatic episodes.
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Affiliation(s)
- Abin Chandrakumar
- Department of Pharmacy Practice, Al Shifa College of Pharmacy, Poonthavanam, Kizhattur P.O, Perinthalmanna, Kerala, 679325.
| | - C Dilip
- Department of Pharmacy Practice, Al Shifa College of Pharmacy, Poonthavanam, Kizhattur P.O, Perinthalmanna, Kerala, 679325
| | - T N K Suriyaprakash
- Department of Pharmaceutics, Al Shifa College of Pharmacy, Poonthavanam, Kizhattur P.O, Perinthalmanna, Kerala, 679325
| | - Levin Thomas
- Department of Pharmacy Practice, Al Shifa College of Pharmacy, Poonthavanam, Kizhattur P.O, Perinthalmanna, Kerala, 679325
| | - Reshma Surendran
- Department of Pharmacy Practice, Al Shifa College of Pharmacy, Poonthavanam, Kizhattur P.O, Perinthalmanna, Kerala, 679325
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Heller SR, Frier BM, Hersløv ML, Gundgaard J, Gough SCL. Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources. Diabet Med 2016; 33:471-7. [PMID: 26179360 PMCID: PMC5034744 DOI: 10.1111/dme.12844] [Citation(s) in RCA: 62] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/23/2015] [Indexed: 12/12/2022]
Abstract
AIMS To assess resource utilization associated with severe hypoglycaemia across three insulin regimens in a large phase 3a clinical programme involving people with Type 1 diabetes treated with basal-bolus insulin, people with Type 2 diabetes treated with multiple daily injections and people with Type 2 diabetes treated with basal-oral therapy. METHODS Data relating to severe hypoglycaemia events (defined as episodes requiring external assistance) from the insulin degludec and insulin degludec/insulin aspart programme (15 trials) were analysed using descriptive statistics. Comparators included insulin glargine, biphasic insulin aspart, insulin detemir and sitagliptin. Mealtime insulin aspart was used in some regimens. This analysis used the serious adverse events records, which documented the use of ambulance/emergency teams, a hospital/emergency room visit ≤ 24 h, or a hospital visit > 24 h. RESULTS In total, 536 severe hypoglycaemia events were analysed, of which 157 (29.3%) involved an ambulance/emergency team, 64 (11.9%) led to hospital/emergency room attendance of ≤ 24 h and 36 (6.7%) required hospital admission (> 24 h). Although there were fewer events in people with Type 2 diabetes compared with Type 1 diabetes, once a severe episode occurred, the tendency to utilize healthcare resources was higher in Type 2 diabetes vs. Type 1 diabetes. A higher proportion (47.6%) in the basal-oral therapy group required hospital treatment for > 24 h versus the Type 1 diabetes (5.0%) and Type 2 diabetes multiple daily injections (5.3%) groups. CONCLUSION This analysis suggests that severe hypoglycaemia events often result in emergency/ambulance calls and hospital treatment, incurring a substantial health economic burden, and were associated with all insulin regimens.
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MESH Headings
- Administration, Oral
- Adult
- Clinical Trials, Phase III as Topic
- Cohort Studies
- Costs and Cost Analysis
- Diabetes Mellitus, Type 1/blood
- Diabetes Mellitus, Type 1/drug therapy
- Diabetes Mellitus, Type 1/economics
- Diabetes Mellitus, Type 2/blood
- Diabetes Mellitus, Type 2/drug therapy
- Diabetes Mellitus, Type 2/economics
- Dipeptidyl-Peptidase IV Inhibitors/administration & dosage
- Dipeptidyl-Peptidase IV Inhibitors/adverse effects
- Dipeptidyl-Peptidase IV Inhibitors/economics
- Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
- Drug Administration Schedule
- Drug Combinations
- Drug Therapy, Combination/adverse effects
- Drug Therapy, Combination/economics
- Health Care Costs
- Humans
- Hypoglycemia/chemically induced
- Hypoglycemia/economics
- Hypoglycemia/physiopathology
- Hypoglycemia/therapy
- Hypoglycemic Agents/administration & dosage
- Hypoglycemic Agents/adverse effects
- Hypoglycemic Agents/economics
- Hypoglycemic Agents/therapeutic use
- Insulin Aspart/administration & dosage
- Insulin Aspart/adverse effects
- Insulin Aspart/economics
- Insulin Aspart/therapeutic use
- Insulin Detemir/administration & dosage
- Insulin Detemir/adverse effects
- Insulin Detemir/economics
- Insulin Detemir/therapeutic use
- Insulin Glargine/administration & dosage
- Insulin Glargine/adverse effects
- Insulin Glargine/economics
- Insulin Glargine/therapeutic use
- Insulin, Long-Acting/administration & dosage
- Insulin, Long-Acting/adverse effects
- Insulin, Long-Acting/economics
- Insulin, Long-Acting/therapeutic use
- Middle Aged
- Severity of Illness Index
- Sitagliptin Phosphate/administration & dosage
- Sitagliptin Phosphate/adverse effects
- Sitagliptin Phosphate/economics
- Sitagliptin Phosphate/therapeutic use
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Affiliation(s)
- S R Heller
- Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK
| | - B M Frier
- The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK
| | - M L Hersløv
- Medical & Science, Novo Nordisk A/S, Søborg, Denmark
| | - J Gundgaard
- Health Economics & HTA, Novo Nordisk A/S, Søborg, Denmark
| | - S C L Gough
- Oxford Centre for Diabetes Endocrinology and Metabolism, Academic Health Science Network, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
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Caferoğlu Z, İnanç N, Hatipoğlu N, Kurtoğlu S. Health-Related Quality of Life and Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus. J Clin Res Pediatr Endocrinol 2016; 8:67-73. [PMID: 26758371 PMCID: PMC4805051 DOI: 10.4274/jcrpe.2051] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/01/2022] Open
Abstract
OBJECTIVE The burdens imposed on a child and his/her parents by a diagnosis of type 1 diabetes mellitus (T1DM) adversely affect their health-related quality of life (HRQoL). HRQoL is important for prognosis and is related to metabolic control. To evaluate the HRQoL of Turkish children and adolescents with T1DM and to assess the correlation of HRQoL subscales (including physical and psychosocial health) with metabolic control, and particularly with hypo- and hyperglycaemic episodes. METHODS This cross-sectional study included 70 participants with T1DM aged between 8 and 18 years (study group) and 72 healthy controls who were matched to the study group in terms of age, gender, and sociodemographic characteristics (control group), and their parents. HRQoL was determined by the Pediatric Quality of Life Inventory. As an indicator of metabolic control, the most recent hemoglobin A1c (HbA1c) levels were obtained and the number of hypo- and hyperglycaemic episodes over the past one month were checked. RESULTS The study group had similar HRQoL scores for children's self-reports and parents' proxy-reports to the control group apart from a decreasing psychosocial health score for parents' proxy-reports in the study group. Although HbA1c level was not related to HRQoL scores, lower number of hypo- and hyperglycaemic episodes were associated with an increase in psychosocial health scores and physical health scores as well as an increase in the total score for parents' proxy-reports. CONCLUSION Although there was no correlation between metabolic control and HRQoL in children's self-reports, the improving HRQoL levels in parents' proxy-reports were associated with good metabolic control.
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Affiliation(s)
- Zeynep Caferoğlu
- Erciyes University Faculty of Health Science, Department of Nutrition and Dietetics, Kayseri, Turkey, E-mail: ,
| | - Neriman İnanç
- Nuh Naci Yazgan University Faculty of Health Science, Department of Nutrition and Dietetics, Kayseri, Turkey
| | - Nihal Hatipoğlu
- Erciyes University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Endocrinology, Kayseri, Turkey
| | - Selim Kurtoğlu
- Erciyes University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Endocrinology, Kayseri, Turkey
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Rhee SY, Hong SM, Chon S, Ahn KJ, Kim SH, Baik SH, Park YS, Nam MS, Lee KW, Woo JT, Kim YS. Hypoglycemia and Medical Expenses in Patients with Type 2 Diabetes Mellitus: An Analysis Based on the Korea National Diabetes Program Cohort. PLoS One 2016; 11:e0148630. [PMID: 26890789 PMCID: PMC4758656 DOI: 10.1371/journal.pone.0148630] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2015] [Accepted: 12/11/2015] [Indexed: 11/24/2022] Open
Abstract
Background and Aims Hypoglycemia is one of the most important adverse events in individuals with type 2 diabetes mellitus (T2DM). However, hypoglycemia-related events are usually overlooked and have been documented less in clinical practice. Materials and Methods We evaluated the incidence, clinical characteristics, and medical expenses of hypoglycemia related events in T2DM patients based on the Korea National Diabetes Program (KNDP), which is the largest multi-center, prospective cohort in Korea (n = 4,350). For accurate outcomes, the KNDP data were merged with claims data from the Health Insurance Review and Assessment Service (HIRA) of Korea. Results During a median follow-up period of 3.23 years (95% CI: 3.14, 3.19), 88 subjects (2.02%) were newly diagnosed with hypoglycemia, and the incidence of hypoglycemia was 6.44 cases per 1,000 person-years (PY). Individuals with hypoglycemia were significantly older (59.7±10.7 vs. 53.3±10.4 years, p < 0.001), had more hospital visits (121.94±126.88 days/PY, p < 0.001), had a longer hospital stays (16.13±29.21 days/PY, p < 0.001), and incurred greater medical costs ($2,447.56±4,056.38 vs. $1,336.37±3,403.39 /PY, p < 0.001) than subjects without hypoglycemia. Conclusion Hypoglycemia-related events were infrequently identified among the medical records of T2DM subjects. However, they were associated significantly with poor clinical outcomes, and thus, hypoglycemia could have a substantial burden on the Korean national healthcare system.
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Affiliation(s)
- Sang Youl Rhee
- Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
| | - Soo Min Hong
- Department of Endocrinology and Metabolism, Graduate School of Medicine, Kyung Hee University, Seoul, Korea
| | - Suk Chon
- Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
| | - Kyu Jeung Ahn
- Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
| | - Sung Hoon Kim
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Cheil General Hospital & Women's Healthcare Center, Dankook University College of Medicine, Seoul, Korea
| | - Sei Hyun Baik
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
| | - Yong Soo Park
- Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea
| | - Moon Suk Nam
- Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
| | - Kwan Woo Lee
- Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea
| | - Jeong-Taek Woo
- Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
| | - Young Seol Kim
- Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
- * E-mail:
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Jafari B, Britton ME. Hypoglycaemia in elderly patients with type 2 diabetes mellitus: a review of risk factors, consequences and prevention. JOURNAL OF PHARMACY PRACTICE AND RESEARCH 2015. [DOI: 10.1002/jppr.1163] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Affiliation(s)
- Badieh Jafari
- Department of General Medicine and Aged Care; Hervey Bay Hospital; Queensland Australia
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Hendrie D, Miller TR, Woodman RJ, Hoti K, Hughes J. Cost-effectiveness of reducing glycaemic episodes through community pharmacy management of patients with type 2 diabetes mellitus. J Prim Prev 2015; 35:439-49. [PMID: 25257687 DOI: 10.1007/s10935-014-0368-x] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
Abstract
Accessibility, availability and frequent public contact place community pharmacists in an ideal position to provide medically necessary, intensive health education and preventive health services to diabetes patients, thus reducing physician burden. We assessed the cost-effectiveness of reducing glycaemic episodes in patients with type 2 diabetes mellitus through a pharmacist-led Diabetes Management Education Program (DMEP) compared to standard care. We recruited eight metropolitan community pharmacies in Perth, Western Australia for the study. We paired them based on geographical location and the socioeconomic status of the population served, and then randomly selected one pharmacy in each pair to be in the intervention group, with the other assigned to the control group. We conducted an incremental cost-effectiveness analysis to compare the costs and effectiveness of DMEP with standard pharmacy care. Cost per patient of implementing DMEP was AU$394 (US$356) for the 6-month intervention period. Significantly greater reductions in number of hyperglycaemic and hypoglycaemic episodes occurred in the intervention relative to the control group [OR 0.34 (95 % CI 0.22, 0.52), p = 0.001; OR 0.54 (95 % CI 0.34, 0.86), p = 0.009], respectively, with a net reduction of 1.86 days with glycaemic episodes per patient per month. The cost-effectiveness of DMEP relative to standard pharmacy care was AU$43 (US$39) per day of glycaemic symptoms avoided. Patients with type 2 diabetes in three surveys were willing to pay an average of 1.9 times that amount to avoid a hypoglycaemic day. We conclude that DMEP decreased days with glycaemic symptoms at a reasonable cost. If a larger-scale replication study confirms these findings, widespread adoption of this approach would improve diabetes health without burdening general practitioners.
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Affiliation(s)
- Delia Hendrie
- Centre for Population Health Research, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia,
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Atkin S, Javed Z, Fulcher G. Insulin degludec and insulin aspart: novel insulins for the management of diabetes mellitus. Ther Adv Chronic Dis 2015; 6:375-88. [PMID: 26568812 PMCID: PMC4622316 DOI: 10.1177/2040622315608646] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
Patients with type 2 diabetes mellitus require insulin as disease progresses to attain or maintain glycaemic targets. Basal insulin is commonly prescribed initially, alone or with one or more rapid-acting prandial insulin doses, to limit mealtime glucose excursions (a basal-bolus regimen). Both patients and physicians must balance the advantages of improved glycaemic control with the risk of hypoglycaemia and increasing regimen complexity. The rapid-acting insulin analogues (insulin aspart, insulin lispro and insulin glulisine) all have similar pharmacokinetic and pharmacodynamic characteristics and clinical efficacy/safety profiles. However, there are important differences in the pharmacokinetic and pharmacodynamic profiles of basal insulins (insulin glargine, insulin detemir and insulin degludec). Insulin degludec is an ultra-long-acting insulin analogue with a flat and stable glucose-lowering profile, a duration of action exceeding 30 h and less inter-patient variation in glucose-lowering effect than insulin glargine. In particular, the chemical properties of insulin degludec have allowed the development of a soluble co-formulation with prandial insulin aspart (insulin degludec/insulin aspart) that provides basal insulin coverage for at least 24 h with additional mealtime insulin for one or two meals depending on dose frequency. Pharmacokinetic and pharmacodynamic studies have shown that the distinct, long basal glucose-lowering action of insulin degludec and the prandial glucose-lowering effect of insulin aspart are maintained in the co-formulation. Evidence from pivotal phase III clinical trials indicates that insulin degludec/insulin aspart translate into sustained glycaemic control with less hypoglycaemia and the potential for a simpler insulin regimen with fewer daily injections.
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Affiliation(s)
- Stephen Atkin
- Weill Cornell Medical College Qatar, Education City, PO Box 24144, Doha, Qatar
| | - Zeeshan Javed
- The Michael White Centre for Diabetes and Endocrinology, Hull Royal Infirmary, Hull, UK
| | - Gregory Fulcher
- Department of Endocrinology, University of Sydney, Royal North Shore Hospital, Sydney, Australia
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Nicolucci A, Pintaudi B, Rossi MC, Messina R, Dotta F, Frontoni S, Caputo S, Lauro R. The social burden of hypoglycemia in the elderly. Acta Diabetol 2015; 52:677-85. [PMID: 25663036 DOI: 10.1007/s00592-015-0717-0] [Citation(s) in RCA: 36] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2014] [Accepted: 01/27/2015] [Indexed: 12/17/2022]
Abstract
AIMS The study aimed to evaluate the frequency of episodes of symptomatic hypoglycemia (SH) in elderly patients with type 2 diabetes and their impact on quality of life. METHODS The study was conducted in 12 Italian regions. Participants filled in a questionnaire collecting data on socio-demographic and clinical characteristics and episodes of SH occurred in the last 4 weeks. The questionnaire included validated scales measuring fear of hypoglycemia (FHQ), psychological well-being (WHO-5), and diabetes-related distress (PAID-5). RESULTS Overall, 1,323 participants were involved (mean age 70.0 ± 8.7, 47.6 % male, disease duration 15.6 ± 11.7, 63.2 % treated with oral agents, 16.9 % with insulin alone, 14.4 % with insulin plus oral agents), of whom 44.6 % reported 1-3 episodes of SH and 23.8 % reported more than 3 episodes. Patients who reported SH had significantly higher levels of fear of hypoglycemia, lower psychological well-being, and higher diabetes-related distress (p < 0.0001 for all the scales). At multivariate analysis, the experience of more than 3 episodes of hypoglycemia was associated with a 13-fold higher risk of high fear of hypoglycemia (aOR = 13.3; CI 95 % 8.4-21.0), an almost 60-fold higher risk of high diabetes-related distress (PAID-5 score ≥40) (aOR = 59.1; CI 95 % 29.2-119.8), and a higher risk of low psychological well-being (WHO-5 <50) (aOR = 1.5; CI 95 % 0.9-2.4). CONCLUSIONS The occurrence of symptoms of hypoglycemia is very common among older adults with diabetes and their presence is associated with an extremely negative impact on quality of life. Minimizing the risk of hypoglycemia represents a high priority in the diabetes treatment of elderly people.
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Affiliation(s)
- Antonio Nicolucci
- Italian Barometer Diabetes Observatory, Università Tor Vergata, Rome, Italy,
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Abstract
In type 2 diabetes (T2DM), glycaemic control delays the development and slows the progression of complications. Although there are numerous glucose-lowering agents in clinical use, only approximately half of T2DM patients achieve glycaemic control, while undesirable side-effects, such as hypoglycaemia and body weight gain, often impede treatment in those taking these medications. Thus, there is a need for novel agents and treatment options. Sodium-glucose cotransporter-2 inhibitors (SGLT-2-i) have recently been developed for the treatment of T2DM. The available data suggest a good tolerability profile for the three available drugs - canagliflozin, dapagliflozin and empagliflozin - approved by the US Food and Drug Administration (FDA) for the American market as well as in other countries. The most frequently reported adverse events with SGLT-2-i are female genital mycotic infections, urinary tract infections and increased urination. The pharmacodynamic response to SGLT-2-i declines with increasing severity of renal impairment, requiring dosage adjustments or restrictions with moderate-to-severe renal dysfunction. Most patients treated with SGLT-2-i also have a modest reduction in blood pressure and modest effects on serum lipid profiles, some of which are beneficial (increased high-density lipoprotein cholesterol and decreased triglycerides) and others which are not (increased low-density lipoprotein cholesterol, LDL-C). A number of large-scale and longer-term cardiovascular trials are now ongoing. In patients treated with dapagliflozin, a non-significant excess number of breast and bladder cancers has been reported; considered as due to a bias, this is nevertheless being followed in the ongoing trials. No other significant safety issues have been reported so far. Although there is some benefit for several cardiovascular risk factors such as HbA1c, high blood pressure, obesity and increases in LDL-C, adequately powered trials are still required to determine the effects of SGLT-2-i on macrovascular outcomes.
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Affiliation(s)
- S Halimi
- Scientific University Joseph-Fourier, and Diabetology Department Pavillon les Écrins, BP 217X, University Hospital Grenoble, 38043 Grenoble Cedex, France
| | - B Vergès
- Department of Endocrinology and Diabetology, University Hospital Dijon, and INSERM CRI 866, Dijon, France
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Martín-Timón I, del Cañizo-Gómez FJ. Mechanisms of hypoglycemia unawareness and implications in diabetic patients. World J Diabetes 2015; 6:912-926. [PMID: 26185599 PMCID: PMC4499525 DOI: 10.4239/wjd.v6.i7.912] [Citation(s) in RCA: 134] [Impact Index Per Article: 13.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/01/2014] [Revised: 12/30/2014] [Accepted: 04/02/2015] [Indexed: 02/05/2023] Open
Abstract
Hypoglycemia unawareness (HU) is defined at the onset of neuroglycopenia before the appearance of autonomic warning symptoms. It is a major limitation to achieving tight diabetes and reduced quality of life. HU occurs in approximately 40% of people with type 1 diabetes mellitus (T1DM) and with less frequency in T2DM. Though the aetiology of HU is multifactorial, possible mechanisms include chronic exposure to low blood glucose, antecedent hypoglycaemia, recurrent severe hypoglycaemia and the failure of counter-regulatory hormones. Clinically it manifests as the inability to recognise impeding hypoglycaemia by symptoms, but the mechanisms and mediators remain largely unknown. Prevention and management of HU is complex, and can only be achieved by a multifactorial intervention of clinical care and structured patient education by the diabetes team. Less know regarding the impact of medications on the development or recognition of this condition in patients with diabetes. Several medications are thought to worsen or promote HU, whereas others may have an attenuating effect on the problem. This article reviews recent advances in how the brain senses and responds to hypoglycaemia, novel mechanisms by which people with insulin-treated diabetes develop HU and impaired counter-regulatory responses. The consequences that HU has on the person with diabetes and their family are also described. Finally, it examines the evidence for prevention and treatment of HU, and summarizes the effects of medications that may influence it.
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Fadini GP, Albiero M, Vigili de Kreutzenberg S, Avogaro A. Hypoglycemia affects the changes in endothelial progenitor cell levels during insulin therapy in type 2 diabetic patients. J Endocrinol Invest 2015; 38:733-8. [PMID: 25722222 DOI: 10.1007/s40618-015-0247-1] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/21/2014] [Accepted: 01/20/2015] [Indexed: 02/07/2023]
Abstract
PURPOSE Hypoglycemia is a barrier to the achievement of glycemic targets and limits the beneficial effects of improved glucose control on cardiovascular outcomes in type 2 diabetes (T2D). Circulating endothelial progenitor cells (EPCs) participate in cardiovascular homeostasis and predict future cardiovascular events. Therefore, we herein analyzed the association between occurrence of hypoglycemia and EPC changes in T2D patients after optimization of glucose control with basal insulin therapy. METHODS In the NCT00699686 trial, 42 T2D insulin-naïve patients received a 3 + 3-month cross-over therapy with glargine and detemir. There were 43 minor and 2 severe hypoglycemic episodes in 19 patients (45.2 %, 0.54 episodes/patient/year). Changes in EPCs were analyzed in relation to the occurrence of hypoglycemia during the trial. RESULTS Patients with hypoglycemia had a higher final HbA1c at 6 months than patients without, although absolute HbA1c changes were not significantly different. Though PCs increased at study end, in patients experiencing at least 1 hypoglycemic episode, the changes in CD34(+), CD133(+) progenitor cells and CD34(+)KDR(+) EPCs were significantly lower than the respective changes in patients without incident hypoglycemia, even after correcting for confounders. During treatment with detemir, which induced >twofold less hypoglycemia than glargine, CD34(+)KDR(+) EPCs increased significantly more than during treatment with glargine. CONCLUSIONS In naïve T2D patients initiating basal insulin, hypoglycemia prevents the increase in vasculoprotective PCs. Clinically, these data strengthen the importance of avoiding hypoglycemia to improve cardiovascular outcomes during the treatment of T2D.
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Affiliation(s)
- G P Fadini
- Department of Medicine, University of Padova, Via Giustiniani, 2, 35128, Padua, Italy.
| | - M Albiero
- Department of Medicine, University of Padova, Via Giustiniani, 2, 35128, Padua, Italy
| | | | - A Avogaro
- Department of Medicine, University of Padova, Via Giustiniani, 2, 35128, Padua, Italy
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Foos V, Varol N, Curtis BH, Boye KS, Grant D, Palmer JL, McEwan P. Economic impact of severe and non-severe hypoglycemia in patients with Type 1 and Type 2 diabetes in the United States. J Med Econ 2015; 18:420-32. [PMID: 25629654 DOI: 10.3111/13696998.2015.1006730] [Citation(s) in RCA: 82] [Impact Index Per Article: 8.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
OBJECTIVE To identify the direct and indirect costs of hypoglycemia in patients with Type 1 or Type 2 diabetes mellitus (DM) in the US setting. METHODS A literature review was conducted to identify and review studies that reported data on the economic burden of hypoglycemia and the related medical resource consumption or productivity loss related to hypoglycemia in patients with Type 1 or Type 2 DM. Relevant information was collated in an economic model to assess the direct and indirect costs following severe and non-severe hypoglycemic events in Type 1 and Type 2 DM. RESULTS Detailed evidence of the medical cost burden of hypoglycemic events was identified from 14 studies. For both Type 1 and Type 2 DM, episodes requiring assistance from a healthcare practitioner were identified as particularly costly and amounted to $1161 per episode (direct costs) compared with episode costs of $66 and $11 for events requiring third-party (non-medical) assistance and events managed by self-treatment, respectively. Indirect costs associated with severe hypoglycemia requiring non-medical assistance, severe hypoglycemia requiring medical assistance, and non-severe hypoglycemia were predicted to be $242, $160, and $11 for patients with Type 1 diabetes and $579, $176, and $11 for patients with Type 2 diabetes, respectively. CONCLUSION Both severe and non-severe hypoglycemia incur substantial healthcare costs. Failure to account for these costs may under-estimate the value of management strategies that minimize hypoglycemia risk.
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Seligman HK, Bolger AF, Guzman D, López A, Bibbins-Domingo K. Exhaustion of food budgets at month's end and hospital admissions for hypoglycemia. Health Aff (Millwood) 2015; 33:116-23. [PMID: 24395943 DOI: 10.1377/hlthaff.2013.0096] [Citation(s) in RCA: 125] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
One in seven US households cannot reliably afford food. Food budgets are more frequently exhausted at the end of a month than at other points in time. We postulated that this monthly pattern influenced health outcomes, such as risk for hypoglycemia among people with diabetes. Using administrative data on inpatient admissions in California for 2000-08, we found that admissions for hypoglycemia were more common in the low-income than the high-income population (270 versus 200 admissions per 100,000). Risk for hypoglycemia admission increased 27 percent in the last week of the month compared to the first week in the low-income population, but we observed no similar temporal variation in the high-income population. These findings suggest that exhaustion of food budgets might be an important driver of health inequities. Policy solutions to improve stable access to nutrition in low-income populations and raise awareness of the health risks of food insecurity might be warranted.
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Roborel de Climens A, Tunceli K, Arnould B, Germain N, Iglay K, Norquist J, Brodovicz KG. Review of patient-reported outcome instruments measuring health-related quality of life and satisfaction in patients with type 2 diabetes treated with oral therapy. Curr Med Res Opin 2015; 31:643-65. [PMID: 25708743 DOI: 10.1185/03007995.2015.1020364] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVE Treatments and their mode of administration may represent a burden for patients and can therefore impact their health-related quality of life (HRQL) or treatment/health satisfaction. Patients with type 2 diabetes mellitus (T2DM) can be treated with oral hypoglycemic agents (OHAs), injectable medications (such as insulin), or a combination of agents. This review aimed to identify patient-reported outcome (PRO) instruments measuring HRQL and/or satisfaction that could differentiate between oral medications based on medication related attributes such as efficacy, tolerability, weight loss, dosing frequency and pill burden. RESEARCH DESIGN AND METHODS Medline, Embase, PsycINFO, Cochrane Library and the Patient-Reported Outcome and Quality of Life Questionnaires (PROQOLID) biomedical databases were searched to identify instruments and document their development methodology, content and psychometric properties (i.e. validity, reliability), responsiveness and ability to detect changes between treatments. RESULTS Nineteen instruments were retained based on their potential to differentiate between OHAs. Ten instruments assessed HRQL, amongst which the Audit of Diabetes Dependent Quality of Life, Diabetes 39, Diabetes Health Profile and Impact of Weight on Quality of Life displayed good psychometric properties in T2DM populations and comprehensive HRQL content. Nine instruments assessed satisfaction. Both the Oral Hypoglycemic Agent Questionnaire (OHAQ) and Diabetes Medication Satisfaction (DiabMedSat) Questionnaire have highly relevant content regarding drug attributes. The OHAQ is specific to oral treatment and the DiabMedSat includes HRQL items. The Diabetes Treatment Satisfaction Questionnaire is a standard instrument that is extensively used and provides conclusive results in studies of patients with T2DM. CONCLUSIONS Very few of the existing PRO instruments are specific to OHAs. Despite satisfaction instruments being recommended to differentiate between OHAs in studies of T2DM based on medication attributes, we find that none of the existing instruments appear to be useful in detecting differences between treatments, therefore limiting their use in clinical and observational research.
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