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Zhou Y, Wheeler BJ, Boucsein A, Styles SE, Chamberlain B, Michaels VR, Crockett HR, Lala A, Cunningham V, Wiltshire EJ, Serlachius AS, Jefferies C. Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA 1c: Extension phase results after a 12-week randomized controlled trial. Diabet Med 2025; 42:e15494. [PMID: 39658881 PMCID: PMC12006559 DOI: 10.1111/dme.15494] [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: 02/07/2024] [Revised: 10/31/2024] [Accepted: 11/11/2024] [Indexed: 12/12/2024]
Abstract
AIM To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA1c (7.5-12.2% [58-110 mmol/mol]). METHODS One hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA1c, CGM metrics, psychological outcomes and device utilization attitudes were measured. RESULTS After the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA1c and time in range (TIR) were non-significant at 24 weeks in both groups. CONCLUSIONS Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.
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Affiliation(s)
- Yongwen Zhou
- Department of Women's and Children's HealthUniversity of OtagoDunedinNew Zealand
- The Third Affiliated Hospital of Sun Yat‐sen UniversityGuangdong Provincial Key Laboratory of DiabetologyGuangzhouChina
| | - Benjamin J. Wheeler
- Department of Women's and Children's HealthUniversity of OtagoDunedinNew Zealand
- Department of PediatricsTe Whatu Ora Health New Zealand—SouthernDunedinNew Zealand
| | - Alisa Boucsein
- Department of Women's and Children's HealthUniversity of OtagoDunedinNew Zealand
| | - Sara E. Styles
- Department of Human NutritionUniversity of OtagoDunedinNew Zealand
| | - Bronte Chamberlain
- Department of Women's and Children's HealthUniversity of OtagoDunedinNew Zealand
- Department of PediatricsTe Whatu Ora Health New Zealand—SouthernDunedinNew Zealand
| | - Venus R. Michaels
- Department of Women's and Children's HealthUniversity of OtagoDunedinNew Zealand
- Department of PediatricsTe Whatu Ora Health New Zealand—SouthernDunedinNew Zealand
| | - Hamish R. Crockett
- Health, Sport and Human Performance, School of HealthUniversity of WaikatoHamiltonNew Zealand
| | - Anita Lala
- Department of PediatricsTe Whatu Ora Health New Zealand—Hauora a Toi, Bay of Plenty New ZealandTaurangaNew Zealand
| | - Vicki Cunningham
- Department of PediatricsTe Whatu Ora Health New Zealand, Te Tai TokerauWhangareiNew Zealand
| | - Esko J. Wiltshire
- Department of PediatricsTe Whatu Ora Health New Zealand—Capital, Coast and Hutt ValleyNewtownNew Zealand
- Department of Pediatrics and Child HealthUniversity of Otago, WellingtonWellingtonNew Zealand
| | | | - Craig Jefferies
- Starship Child HealthTe Whatu Ora—Health New Zealand, Te Toka Tumai AucklandAucklandNew Zealand
- Liggins Institute and Department of PediatricsThe University of AucklandAucklandNew Zealand
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Kim J, Cuevas H. Associations between physical activity, glucose variability, and cognitive function in older adults with type 2 diabetes. Geriatr Nurs 2025; 63:45-50. [PMID: 40158326 DOI: 10.1016/j.gerinurse.2025.03.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2024] [Revised: 02/07/2025] [Accepted: 03/19/2025] [Indexed: 04/02/2025]
Abstract
Higher glucose variability is linked to cognitive impairment in older adults with type 2 diabetes. While physical activity can reduce glucose variability and improve cognitive function, these relationships remain unexplored using continuous glucose monitoring. This study examined associations between physical activity, glucose variability, and cognitive function through secondary data analysis of 87 older adults with type 2 diabetes using self-reported questionnaires, computerized cognitive assessments, and continuous glucose monitoring data. Subgroup analysis showed that physical activity was associated with better cognitive function in individuals with lower cognitive function but not in those with higher cognitive function. This suggests that the effects of physical activity may vary depending on cognitive status. Future research should incorporate objective physical activity measures and longer-duration continuous glucose monitoring to explore how activity intensity, type, and timing influence glucose variability and cognitive outcomes, informing targeted interventions for this population.
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Affiliation(s)
- Jeeyeon Kim
- Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA.
| | - Heather Cuevas
- School of Nursing, University of Texas at Austin, Austin, TX, USA.
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Burleson J, Stephens DE, Rimal RN. Adherence Definitions, Measurement Modalities, and Psychometric Properties in HIV, Diabetes, and Nutritional Supplementation Studies: A Scoping Review. Patient Prefer Adherence 2025; 19:319-344. [PMID: 39958701 PMCID: PMC11829600 DOI: 10.2147/ppa.s498537] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/29/2024] [Accepted: 01/12/2025] [Indexed: 02/18/2025] Open
Abstract
Measuring adherence has been a priority for researchers to help inform effective care for patients regularly consuming medications for chronic conditions. As a widely accepted "gold standard" adherence measure or operational definition does not exist, studies measure adherence using different modalities, which may lead to different conclusions about adherence patterns. The purpose of the scoping review was to identify modalities used to measure adherence to HIV medication, diabetes medication, and nutritional supplementation and explore the variation in adherence definitions, measurement modalities, and psychometric properties being reported across studies. Comprehensive searches were performed in PubMed, Scopus, and PsycINFO from January 2012 to January 2022. We included studies reporting psychometric properties of adherence/compliance to HIV medication, diabetes medication, or nutritional supplements. In total, we included 88 studies in the review. The 8-item Morisky Medication Adherence Scale (MMAS-8) was the most frequently used self-reported measure. We found almost no relationship between country income level and triangulation levels. The operational definition of adherence fell into four categories: numerical, dichotomous, ranked ordinal, and undefined. The amount of variation in an adherence definition category within a modality depended on whether the measures within the modality could be assessed numerically and whether widely accepted cutoffs existed for the measure. Across studies, 46 (52%) reported both validity and reliability, 28 (31%) reported validity only, and 14 (16%) reported reliability only. Fourteen types of validity and six types of reliability were identified across the studies. Measuring adherence accurately and reliably continues to be a challenge for research in HIV, diabetes, and nutritional supplementations. When reporting adherence measurements, we suggest including adherence results from multiple measures and modalities, presenting adherence results numerically, and reporting multiple types of validity and reliability.
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Affiliation(s)
- Julia Burleson
- Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
| | - Daryl E Stephens
- Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
| | - Rajiv N Rimal
- Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
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Tauschmann M, Cardona-Hernandez R, DeSalvo DJ, Hood K, Laptev DN, Lindholm Olinder A, Wheeler BJ, Smart CE. International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024 Diabetes Technologies: Glucose Monitoring. Horm Res Paediatr 2025; 97:615-635. [PMID: 39884260 PMCID: PMC11854985 DOI: 10.1159/000543156] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2024] [Accepted: 12/04/2024] [Indexed: 02/01/2025] Open
Abstract
The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents.
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Affiliation(s)
- Martin Tauschmann
- Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria
| | | | - Daniel J DeSalvo
- Baylor College of Medicine, Texas Children's Hospital, Houston, Texas, USA
| | - Korey Hood
- Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California, USA
| | - Dmitry N Laptev
- Department of Pediatric Endocrinology, Endocrinology Research Center, Moscow, Russian Federation
| | - Anna Lindholm Olinder
- Department of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Stockholm, Sweden
- Sachs' Children and Youths Hospital, Södersjukhuset, Stockholm, Sweden
| | - Benjamin J Wheeler
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
- Paediatrics, Health New Zealand - Southern, Dunedin, New Zealand
| | - Carmel E Smart
- Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, New South Wales, Australia
- School of Health Sciences, University of Newcastle, Newcastle, New South Wales, Australia
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Kondo T, Senokuchi T, Morinaga J, Miyashita A, Yano M, Takeda H, Nishida K, Kubota N. The benefits and accuracy of real-time continuous glucose monitoring in children and adolescents with type 1 diabetes attending a summer camp. J Diabetes Investig 2025; 16:154-162. [PMID: 39474860 DOI: 10.1111/jdi.14337] [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: 07/11/2024] [Revised: 09/05/2024] [Accepted: 10/08/2024] [Indexed: 01/03/2025] Open
Abstract
AIMS/INTRODUCTION This study evaluated the usability, satisfaction, and accuracy of a real-time continuous glucose monitoring (rt-CGM) in children and adolescents with type 1 diabetes (T1D) attending a summer camp. MATERIALS AND METHODS Seven children and adolescents with T1D (camper) and 31 of healthcare providers (HCPs) participating in a 2-day summer camp in Kumamoto, Japan were enrolled. The usability and satisfaction were evaluated by tailored questionnaire. The accuracy of rt-CGM was evaluated using self-monitoring of blood glucose (BG) and sensor glucose (SG) values before or after (off camp) and during (on camp) the camp. RESULTS The score of the usefulness of rt-CGM showed 3.29 ± 0.90 in campers and 4.23 ± 0.87 in HCPs (P = 0.017). The degree of recommendation score for rt-CGM was 3.29 ± 1.11 in campers and 4.23 ± 0.79 in HCPs (P = 0.013). Time in range (TIR) off camp was 45.9% and that on camp was 57.0%. Time above range (TAR) off camp was 53.4% and that on camp was 42.4%. The mean absolute relative difference (MARD) off camp was 19.7% ± 25.2%, whereas that on camp was 16.0% ± 14.8% (P = 0.367). Clinically acceptable zones of the error grid analyses were approximately 96% in total. CONCLUSIONS Rt-CGM exhibited higher usability and recommendation scores in HCPs than those in campers. This may be related to relatively lower accuracy in rt-CGM. Overall usability and recommendation are clinically satisfactory, but due to relatively low accuracy, no decision should be made based on a single, non-verified SG value alone.
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Affiliation(s)
- Tatsuya Kondo
- Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
- Department of Diabetes, Metabolism and Endocrinology, Aso Medical Center, Aso, Japan
| | - Takafumi Senokuchi
- Department of Diabetes, Metabolism and Endocrinology, Kumamoto University Hospital, Kumamoto, Japan
| | - Jun Morinaga
- Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto, Japan
| | - Azusa Miyashita
- Department of Clinical Investigation, Kumamoto University Hospital, Kumamoto, Japan
| | - Mayumi Yano
- Division of Diabetology, Morinoki Clinic, Kumamoto, Japan
| | - Haruo Takeda
- Division of Diabetology, Misato Rehabilitation Clinic, Kumamoto, Japan
| | - Kenro Nishida
- Division of Diabetes, Endocrinology and Metabolism, Kumamoto Chuo Hospital, Kumamoto, Japan
| | - Naoto Kubota
- Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
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Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Schritz A, Vaillant M, Barnard-Kelly K, Cohen O, Gies I, de Beaufort C. Fear of hypoglycemia and sleep in children with type 1 diabetes and their parents. Front Endocrinol (Lausanne) 2024; 15:1419502. [PMID: 39736868 PMCID: PMC11682895 DOI: 10.3389/fendo.2024.1419502] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/18/2024] [Accepted: 11/18/2024] [Indexed: 01/01/2025] Open
Abstract
Aims To compare impact of pump treatment and continuous glucose monitoring (CGM) with predictive low glucose suspend (SmartGuard) or user initiated CGM (iscCGM) on sleep and hypoglycemia fear in children with type 1 Diabetes and parents. Methods Secondary analysis of data from 5 weeks pump treatment with iscCGM (A) or SmartGuard (B) open label, single center, randomized cross-over study was performed. At baseline and end of treatment arms, sleep and fear of hypoglycemia were evaluated using ActiGraph and questionnaires. Results 31 children (6-14 years, male: 50%) and 30 parents (28-55 years) participated. Total sleep minutes did not differ significantly for children (B vs. A: -9.27; 95% CI [-24.88; 6.34]; p 0.26) or parents (B vs. A: 5.49; 95% CI [-8.79; 19.77]; p 0.46). Neither daytime sleepiness nor hypoglycemia fear in children or parents differed significantly between the systems. Neither group met recommended sleep criteria. Conclusion Lack of sleep and fear of hypoglycemia remain a major burden for children with diabetes and their parents. Whilst no significant differences between the systems were found, future technology should consider psychosocial impacts of diabetes and related technologies on children and parents' lived experience to ensure parity of esteem between physical and mental health outcomes. Clinical Trial Registration www.ClinicalTrials.gov, identifier NCT03103867.
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Affiliation(s)
- Ulrike Schierloh
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg, Luxembourg
| | - Gloria A. Aguayo
- Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, Luxembourg
| | - Muriel Fichelle
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg, Luxembourg
| | - Cindy De Melo Dias
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg, Luxembourg
| | - Anna Schritz
- Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg
| | - Michel Vaillant
- Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg
| | | | - Ohad Cohen
- Institute of Endocrinology, Sheba Medical Center, Tel Hashomer, Israel
| | - Inge Gies
- Division of Pediatric Endocrinology, Department of Pediatrics, University Hospital Brussels, Brussels, Belgium
- Research Unit Research Group Growth and Development (GRON), Vrije Universiteit Brussel, Brussels, Belgium
| | - Carine de Beaufort
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg, Luxembourg
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Urakami T, Terada H, Tanabe S, Mine Y, Aoki M, Aoki R, Suzuki J, Morioka I. Clinical significance of coefficient of variation in continuous glucose monitoring for glycemic management in children and adolescents with type 1 diabetes. J Diabetes Investig 2024; 15:1669-1674. [PMID: 39230367 PMCID: PMC11527802 DOI: 10.1111/jdi.14303] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2024] [Revised: 08/03/2024] [Accepted: 08/20/2024] [Indexed: 09/05/2024] Open
Abstract
AIMS/INTRODUCTION Coefficient of variation (CV) is an indicator for glucose variability in continuous glucose monitoring (CGM), and the target threshold of %CV in type 1 diabetes is proposed to be ≤36%. This study aimed to evaluate the clinical significance of CV in children and adolescents with type 1 diabetes. MATERIALS AND METHODS Participants included 66 children with type 1 diabetes. A total of 48 participants were treated with multiple daily injections of insulin, and 18 with continues subcutaneous insulin infusion, using intermittently scanned CGM. The frequencies of the CGM metrics and glycosylated hemoglobin values were examined, and the significance of a threshold %CV of 36% was evaluated. RESULTS The mean frequencies in time in range (TIR), time below range, %CV and the mean glycosylated hemoglobin value were 59.3 ± 16.1, 4.0 ± 3.5, 39.3 ± 6.2 and 7.3 ± 0.8%, respectively. The frequencies of participants who achieved a TIR >70% and a %CV of ≤36% were 24.1 and 27.3%, respectively. A total of 18 participants with a %CV of ≤36% had significantly higher TIR, lower time below range and lower glycosylated hemoglobin than the 48 with a %CV of >36% (72.6 ± 12.6 vs 52.4 ± 13.6, 2.4 ± 1.9 vs 4.6 ± 3.6, 6.9 ± 0.8 vs 7.4 ± 0.7%, respectively). CONCLUSIONS Children and adolescents with type 1 diabetes using intermittently scanned CGM had difficulties in achieving the recommended targets of TIR and CV. However, the target %CV of ≤36% seems to be an appropriate indicator for assessing glycemic control and risk of hypoglycemia in pediatric patients with type 1 diabetes with any treatment.
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Affiliation(s)
- Tatsuhiko Urakami
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
- Urakami Pediatric Endocrinology and Diabetes ClinicTokyoJapan
| | - Hiroki Terada
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
| | - Satomi Tanabe
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
| | - Yusuke Mine
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
| | - Masako Aoki
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
| | - Ryoji Aoki
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
| | - Junichi Suzuki
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
| | - Ichiro Morioka
- Department of Pediatrics and Child HealthNihon University School of MedicineTokyoJapan
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Liu Y, Zhang J, Chun X, Gao Y, Yao R, Liang Y, Zhu L, He Y, Huang W. Performance of Continuous Glucose Monitoring in Patients With Acute Respiratory Failure: A Prospective, Single-Center Observational Study. Endocr Pract 2024; 30:795-801. [PMID: 38876178 DOI: 10.1016/j.eprac.2024.06.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/13/2024] [Revised: 05/23/2024] [Accepted: 06/06/2024] [Indexed: 06/16/2024]
Abstract
OBJECTIVE Continuous glucose monitoring (CGM) may have benefits in achieving glycemic control in critically ill patients. The aim of this study was to assess the accuracy of the Freestyle Libre H (professional version similar to the Libre Pro) in patients with acute respiratory failure (ARF) in the intensive care unit (ICU). METHODS Fifty-two adult patients with ARF were selected. The performance of CGM was evaluated using the arterial blood glucose (aBG) and point-of-care (POC) glucose levels as the reference values. Numerical accuracy was evaluated by the mean absolute relative difference, Bland-Altman analysis, %15/15 (the percentage of CGM values within 15 mg/dL or 15% of reference values <100 or >100 mg/dL, respectively), %20/20, and %30/30. Clinical accuracy was assessed using the Clarke error grid analysis. RESULTS A total of 519 and 1504 pairs of aBG/CGM and POC/CGM glucose values were analyzed. The mean absolute relative difference values were 13.8% and 14.7%, respectively. The mean deviations of the Bland-Altman analysis were 0.82 mmol/L and 0.81 mmol/L. The proportions of CGM values within %15/15, %20/20, and %30/30 of the aBG values were 62.6%, 75.5%, and 92.4%, respectively; those within %15/15, %20/20, and %30/30 of the POC values were 57.1%, 72.9%, and 88.7%, respectively. The Clarke error grid analysis showed that 97.8% and 99.3% of the values were located in zone A + B. Additionally, the accuracy of CGM was not affected by general patient factors. CONCLUSION This study demonstrated that the accuracy of CGM in patients with ARF is lower than that in most outpatients and it is not affected by general patient factors. Whether CGM is beneficial to glucose management in the intensive care unit needs further evaluation.
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Affiliation(s)
- Yanhua Liu
- Department of Emergency Medicine, West China Hospital, Sichuan University/West China School of Nursing/Disaster Medicine Center, Sichuan University, Chengdu, China; Institute of Disaster Medicine, Sichuan University, Chengdu, China; Nursing Key Laboratory of Sichuan Province, Sichuan University, Chengdu, China
| | - Jianna Zhang
- Department of Emergency Medicine, West China Hospital, Sichuan University/West China School of Nursing/Disaster Medicine Center, Sichuan University, Chengdu, China; Institute of Disaster Medicine, Sichuan University, Chengdu, China; Nursing Key Laboratory of Sichuan Province, Sichuan University, Chengdu, China
| | - Xueli Chun
- Center of Gerontology and Geriatrics, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, China
| | - Yongli Gao
- Department of Emergency Medicine, West China Hospital, Sichuan University/West China School of Nursing/Disaster Medicine Center, Sichuan University, Chengdu, China; Institute of Disaster Medicine, Sichuan University, Chengdu, China; Nursing Key Laboratory of Sichuan Province, Sichuan University, Chengdu, China
| | - Rong Yao
- Department of Emergency Medicine, West China Hospital, Sichuan University/West China School of Nursing/Disaster Medicine Center, Sichuan University, Chengdu, China; Institute of Disaster Medicine, Sichuan University, Chengdu, China; Nursing Key Laboratory of Sichuan Province, Sichuan University, Chengdu, China
| | - Yin Liang
- Department of Emergency Medicine, West China Hospital, Sichuan University/West China School of Nursing/Disaster Medicine Center, Sichuan University, Chengdu, China; Institute of Disaster Medicine, Sichuan University, Chengdu, China; Nursing Key Laboratory of Sichuan Province, Sichuan University, Chengdu, China
| | - Ling Zhu
- Department of Emergency Medicine, West China Hospital, Sichuan University/West China School of Nursing/Disaster Medicine Center, Sichuan University, Chengdu, China; Institute of Disaster Medicine, Sichuan University, Chengdu, China; Nursing Key Laboratory of Sichuan Province, Sichuan University, Chengdu, China
| | - Ying He
- Anesthesia & Operation Center, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, China
| | - Wenxia Huang
- General Practice Medical Center, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, China.
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9
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Pleus S, Eichenlaub M, Waldenmaier D, Freckmann G. A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance. J Diabetes Sci Technol 2024; 18:847-856. [PMID: 38477308 PMCID: PMC11307228 DOI: 10.1177/19322968241236504] [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: 03/14/2024]
Abstract
Many continuous glucose monitoring (CGM) systems provide functionality which alerts users of potentially unwanted glycemic conditions. These alerts can include glucose threshold alerts to call the user's attention to hypoglycemia or hyperglycemia, predictive alerts warning about impeding hypoglycemia or hyperglycemia, and rate-of-change alerts. A recent review identified 129 articles about CGM performance studies, of which approximately 25% contained alert evaluations. In some studies, real alerts were assessed; however, most of these studies retrospectively determined the timing of CGM alerts because not all CGM systems record alerts which necessitates manual documentation. In contrast to assessment of real alerts, retrospective determination allows assessment of a variety of alert settings for all three types of glycemic condition alerts. Based on the literature and the Clinical and Laboratory Standards Institute's POCT05 guideline, two common approaches to threshold alert evaluation were identified, one value-based and one episode-based approach. In this review, a critical discussion of the two approaches, including a post hoc analysis of clinical study data, indicates that the episode-based approach should be preferred over the value-based approach. For predictive alerts, fewer results were found in the literature, and retrospective determination of CGM alert timing is complicated by the prediction algorithms being proprietary information. Rate-of-change alert evaluations were not reported in the identified literature, and POCT05 does not contain recommendations for assessment. A possible approach is discussed including post hoc analysis of clinical study data. To conclude, CGM systems should record alerts, and the episode-based approach to alert evaluation should be preferred.
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Affiliation(s)
- Stefan Pleus
- Institut für Diabetes-Technologie,
Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm,
Germany
| | - Manuel Eichenlaub
- Institut für Diabetes-Technologie,
Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm,
Germany
| | - Delia Waldenmaier
- Institut für Diabetes-Technologie,
Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm,
Germany
| | - Guido Freckmann
- Institut für Diabetes-Technologie,
Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm,
Germany
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10
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Bilgehan T, Uludaşdemir D. Insomnia severity among caregivers of children with type 1 diabetes: A mixed method study. J Pediatr Nurs 2024; 77:e375-e384. [PMID: 38724314 DOI: 10.1016/j.pedn.2024.04.054] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2024] [Revised: 04/30/2024] [Accepted: 04/30/2024] [Indexed: 07/07/2024]
Abstract
AIM This research was conducted to assess the severity of insomnia experienced by caregivers of children with type 1 diabetes. METHOD In this study, a mixed-method descriptive sequential pattern design was employed, incorporating both qualitative and quantitative research methods. In the study, 152 caregivers were surveyed for quantitative data on survey form and insomnia severity. Additionally, 9 mothers underwent semi-structured interviews for qualitative insights. RESULTS Of caregivers, 13.8% were identified to experience clinical insomnia. There were statistically significant differences in insomnia severity index scores in terms of experiencing sleep problems after the child's type 1 diabetes diagnosis, caregivers having adequate sleep duration at night, how they felt on waking in the morning, difficulty managing their child's diabetes the next day due to lack of sleep, difficulty getting to sleep at night, sleeping more than one hour during the day, lack of sleep due to caring and treatment, lack of sleep due to not meeting the desired targets for blood glucose values and receiving support for type 1 diabetes management due to lack of sleep (p < 0.05). Three themes were identified as a result of qualitative analysis: Sleep status of caregivers, effect of sleep problems on daily life and solving sleep problems. CONCLUSIONS Caregivers experience insomnia during the process of type 1 diabetes management and this situation affects their daytime care duties. PRACTICAL IMPLICATIONS Research shows caregivers of children with type 1 diabetes often face insomnia, highlighting the need for solutions.
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Affiliation(s)
- Tuğba Bilgehan
- Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Internal Medicine Nursing, Esenboga, Ankara, Turkey.
| | - Dilek Uludaşdemir
- Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Child Health and Disease Nursing, Esenboga, Ankara, Turkey
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von Kobyletzki LB, Ulriksdotter J, Sukakul T, Aerts O, Agner T, Buhl T, Bruze M, Foti C, Gimenez-Arnau A, Gonçalo M, Hamnerius N, Johansen JD, Rustemeyer T, Stingeni L, Wilkinson M, Svedman C. Prevalence of dermatitis including allergic contact dermatitis from medical devices used by children and adults with Type 1 diabetes mellitus: A systematic review and questionnaire study. J Eur Acad Dermatol Venereol 2024; 38:1329-1346. [PMID: 38400603 DOI: 10.1111/jdv.19908] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2023] [Accepted: 01/23/2024] [Indexed: 02/25/2024]
Abstract
Use of medical devices (MDs), that is, glucose sensors and insulin pumps, in patients with Type 1 diabetes mellitus (T1D) has proven an enormous advantage for disease control. Adverse skin reactions from these MDs may however hamper compliance. The objective of this study was to systematically review and analyse studies assessing the prevalence and incidence of dermatitis, including allergic contact dermatitis (ACD) related to MDs used in patients with T1D and to compare referral routes and the clinical investigation routines between clinics being part of the European Environmental and Contact Dermatitis Research Group (EECDRG). A systematic search of PubMed, EMBASE, CINAHL and Cochrane databases of full-text studies reporting incidence and prevalence of dermatitis in persons with T1D using MDs was conducted until December 2021. The Newcastle-Ottawa Scale was used to assess study quality. The inventory performed at EECRDG clinics focused on referral routes, patient numbers and the diagnostic process. Among the 3145 screened abstracts, 39 studies fulfilled the inclusion criteria. Sixteen studies included data on children only, 14 studies were on adults and nine studies reported data on both children and adults. Participants were exposed to a broad range of devices. Skin reactions were rarely specified. It was found that both the diagnostic process and referral routes differ in different centres. Further data on the prevalence of skin reactions related to MDs in individuals with T1D is needed and particularly studies where the skin reactions are correctly diagnosed. A correct diagnosis is delayed or hampered by the fact that, at present, the actual substances within the MDs are not declared, are changed without notice and the commercially available test materials are not adequately updated. Within Europe, routines for referral should be made more standardized to improve the diagnostic procedure when investigating patients with possible ACD from MDs.
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Affiliation(s)
- L B von Kobyletzki
- Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden
- School of Medical Sciences, Örebro University, Örebro, Sweden
| | - J Ulriksdotter
- Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden
| | - T Sukakul
- Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden
| | - O Aerts
- Contact Allergy Unit, Department of Dermatology, University Hospital Antwerp (UZA) and Research Group Immunology, University of Antwerp, Antwerp, Belgium
| | - T Agner
- Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark
| | - T Buhl
- Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany
| | - M Bruze
- Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden
| | - C Foti
- Section of Dermatology, DIMEPREJ Department, University "Aldo Moro", Bari, Italy
| | - A Gimenez-Arnau
- Department of Dermatology, Hospital del Mar and Research Institute de Barcelona, Universitat Pompeu Fabra, Barcelona, Spain
| | - M Gonçalo
- Clinic of Dermatology, Coimbra University Hospital and Faculty of Medicine, University of Coimbra, Coimbra, Portugal
| | - N Hamnerius
- Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden
| | - J D Johansen
- Department of Dermatology, Herlev and Gentofte Hospital, Copenhagen, Denmark
| | - T Rustemeyer
- Dermato-Allergology and Occupational Dermatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - L Stingeni
- Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy
| | - M Wilkinson
- Leeds Teaching Hospitals, NHS Trust, Leeds, UK
| | - C Svedman
- Department of Occupational and Environmental Dermatology, Lund University, Skåne University Hospital, Malmö, Sweden
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12
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Alazmi AA, Brema I, Alzahrani SH, Almehthel MS. The Relationship Between Hemoglobin A1c, Time in Range, and Glycemic Management Indicator in Patients With Type 1 and Type 2 Diabetes in a Tertiary Care Hospital in Saudi Arabia. Cureus 2024; 16:e63947. [PMID: 39105008 PMCID: PMC11299043 DOI: 10.7759/cureus.63947] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/29/2024] [Indexed: 08/07/2024] Open
Abstract
OBJECTIVES This study aimed to assess the correlation between glycated hemoglobin A1 (HbA1c), time in range (TIR), and glycemic management indicator (GMI) in patients with both type 1 diabetes (T1D) and type 2 diabetes (T2D) who were using a flash glucose monitoring (FGM) device (FreeStyle Libre; Abbott Diabetic Care, Witney, UK). METHODS This was a retrospective study that looked at T1D and T2D FreeStyle Libre users' LibreView database in the period between January 2020 to June 2022. The study was conducted at the diabetes department at the King Fahad Medical City (KFMC) in Riyadh, Saudi Arabia, following Institutional Review Board (IRB) approval. Data were collected from the LibreView website, as well as from the electronic privacy information center (EPIC) hospital records. RESULTS Data were available for 327 patients, mean age of 33.08(±17.1) years old, and 55.7% were females. HbA1c had a statistically significant correlation with both TIR and GMI with coefficient of correlation (r) values of 0.78 (p<0.001) and 0.82 (p<0.001), respectively. A linear regression model between TIR and Hb1Ac was also developed and found to be statistically significant (p<0.001) with an acceptable R2 value (0.60). CONCLUSION Study findings revealed that the %TIR could be a reliable predictor of Hb1Ac. Thus, Freestyle Libre was able to determine Hb1Ac as close to the lab results as possible. Therefore, it is necessary to encourage diabetes patients to achieve at least 70% TIR in order to keep Hb1Ac within the desired range.
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Affiliation(s)
- Ahmed A Alazmi
- Obesity, Endocrine, and Metabolism Center, King Fahad Medical City, Riyadh, SAU
- Family Medicine and Endocrine Department, King Fahad Specialist Hospital, Dammam, SAU
| | - Imad Brema
- Obesity, Endocrine, and Metabolism Center, King Fahad Medical City, Riyadh, SAU
- College of Medicine, Alfaisal University, Riyadh, SAU
| | - Saad H Alzahrani
- Obesity, Endocrine, and Metabolism Center, King Fahad Medical City, Riyadh, SAU
| | - Mohammed S Almehthel
- Obesity, Endocrine, and Metabolism Center, King Fahad Medical City, Riyadh, SAU
- Division of Endocrinology, University of British Columbia, Vancouver, CAN
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Al Hayek A, Robert AA, Alzahrani WM, Al Dawish MA. Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes. Curr Diabetes Rev 2024; 20:e100823219628. [PMID: 37563819 DOI: 10.2174/1573399820666230810123504] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/25/2023] [Revised: 05/30/2023] [Accepted: 07/02/2023] [Indexed: 08/12/2023]
Abstract
BACKGROUND AND AIMS This study aims to assess patient-reported satisfaction and metabolic outcomes following the initiation of the second generation of the Freestyle Libre 2 (FSL2) system in patients with type 1 diabetes (T1D). METHODS This non-randomized single-arm observation study was conducted on 86 patients with T1D living in Saudi Arabia, who were asked to wear the FSL2 for 12 weeks. The demographic data were collected at baseline, while the continuous glucose monitoring (CGM) metrics were gathered, i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events were collected at baseline, 6th week and 12 weeks. Further, the Continuous Glucose Monitoring Satisfaction (CGM-SAT) was collected at the end of the follow-up. RESULTS Compared to the 6th week, significant differences were observed in the low glucose events (p = 0.037), % TIR (p = 0.045), and % below 70 mg/dL (p = 0.047) at 12 weeks. Improvement was seen in the other glucometric variables, but no significant changes were evident (p > 0.05). On completion of the study period, the ambulatory glucose profile (AGP) metrics showed a 74.3 ± 5.01 (mg/dL) FSL2 hypoglycemia alarm threshold and a 213 ± 38.1 (mg/dL) hyperglycemia alarm threshold. A majority of the patients stated that CGM-SAT had benefits (mean score > 3.58), although they felt FSL2 had 'additional benefits. With regard to the problems with the use of FSL2 majority of the patients stated that FSL2 has minimal discomfort. CONCLUSION Using second-generation FSL2 in patients with T1D is positively associated with patient- reported satisfaction and metabolic outcomes.
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Affiliation(s)
- Ayman Al Hayek
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia
| | - Asirvatham Alwin Robert
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia
| | - Wael M Alzahrani
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia
| | - Mohamed Abdulaziz Al Dawish
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia
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Freckmann G, Eichenlaub M, Waldenmaier D, Pleus S, Wehrstedt S, Haug C, Witthauer L, Jendle J, Hinzmann R, Thomas A, Eriksson Boija E, Makris K, Diem P, Tran N, Klonoff DC, Nichols JH, Slingerland RJ. Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting. J Diabetes Sci Technol 2023; 17:1506-1526. [PMID: 37599389 PMCID: PMC10658695 DOI: 10.1177/19322968231190941] [Citation(s) in RCA: 16] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/22/2023]
Abstract
The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation. We found that there is a large variability in nearly all of those aspects and, in particular, in the characteristics of the comparator measurements. Furthermore, these characteristics as well as other crucial aspects of study design are often not reported in sufficient detail to allow an informed interpretation of study results. We therefore provide recommendations for reporting the general study design, CGM system use, comparator measurement approach, testing procedures, and data analysis/statistical performance evaluation. Additionally, this review aims to serve as a foundation for the development of a standardized CGM performance evaluation procedure, thereby supporting the goals and objectives of the Working Group on CGM established by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine.
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Affiliation(s)
- Guido Freckmann
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Manuel Eichenlaub
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Delia Waldenmaier
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Stefan Pleus
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Stephanie Wehrstedt
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Cornelia Haug
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Lilian Witthauer
- Diabetes Center Berne, Bern, Switzerland
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, Bern University Hospital and University of Bern, Bern, Switzerland
| | - Johan Jendle
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
| | - Rolf Hinzmann
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Roche Diabetes Care GmbH, Mannheim, Germany
| | - Andreas Thomas
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Pirna, Germany
| | - Elisabet Eriksson Boija
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Equalis AB, Uppsala, Sweden
| | - Konstantinos Makris
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Clinical Biochemistry Department, KAT General Hospital, Athens, Greece
| | - Peter Diem
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Endokrinologie Diabetologie Bern, Bern, Switzerland
| | - Nam Tran
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Department of Pathology and Laboratory Medicine, University of California Davis Health, Sacramento, CA, USA
| | - David C. Klonoff
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA
| | - James H. Nichols
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Vanderbilt University Medical Center, Nashville, TN, USA
| | - Robbert J. Slingerland
- IFCC Scientific Division - Working Group on Continuous Glucose Monitoring
- Department of Clinical Chemistry, Isala Clinics, Zwolle, the Netherlands
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Kutney K, Kaminski BA, Casey T, O'Riordan M, Gubitosi-Klug R. Reproducibility of in-home CFRD screening using continuous glucose monitoring and mixed meal tolerance test. J Clin Transl Endocrinol 2023; 33:100323. [PMID: 37705602 PMCID: PMC10495624 DOI: 10.1016/j.jcte.2023.100323] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2023] [Revised: 07/23/2023] [Accepted: 08/24/2023] [Indexed: 09/15/2023] Open
Abstract
Background Cystic fibrosis related diabetes (CFRD) is associated with insulin-remediable pulmonary decline, so early detection is critical. Continuous glucose monitors (CGM) have shown promise in screening but are not recommended by clinical practice guidelines. Little is known about the reproducibility of CGM results for a given patient. Methods Twenty non-insulin treated adults and adolescents with CF placed an in-home CGM and wore it for two 14-day periods. Participants underwent a mixed meal tolerance test (MMTT) on day 5 of each 14-day period. Glycemic data from CGM 1 and CGM 2 were compared regarding published thresholds to define abnormality: percent time >140 mg/dL of ≥4.5%, percent time >140 mg/dL of >17.5%, and percent time >180 mg/dL of >3.4%. Results of the repeat MMTT were compared for peak glucose and 2-hour glucose thresholds: >140 mg/dL, >180 mg/dL, and >200 mg/dL. Results For percent time >140 mg/dL of ≥ 4.5%, five of 20 subjects had conflicting results between CGM 1 and CGM 2. For percent time >140 mg/dL of >17.5% and >180 mg/dL of >3.4%, only one of 20 subjects had conflicting results between CGM 1 and CGM 2. On the MMTT, few participants had a 2-hour glucose >140 mg/dL. Peak glucose >140 mg/dL, 180 mg/dL, and 200 mg/dL were more common, with 10-37% of participants demonstrating disagreement between CGM 1 and CGM 2. Conclusions Repeated in-home CGM acquisitions show reasonable reproducibility regarding the more stringent thresholds for time >140 mg/dL and >180 mg/dL. More data is needed to determine thresholds for abnormal mixed meal tolerance tests in CFRD screening.
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Affiliation(s)
- Katherine Kutney
- Case Western Reserve University, Cleveland OH, United States
- University Hospitals Rainbow Babies and Children’s Hospital, Cleveland OH, United States
| | - Beth A. Kaminski
- Case Western Reserve University, Cleveland OH, United States
- University Hospitals Rainbow Babies and Children’s Hospital, Cleveland OH, United States
| | - Terri Casey
- Case Western Reserve University, Cleveland OH, United States
- University Hospitals Rainbow Babies and Children’s Hospital, Cleveland OH, United States
| | - MaryAnn O'Riordan
- Case Western Reserve University, Cleveland OH, United States
- University Hospitals Rainbow Babies and Children’s Hospital, Cleveland OH, United States
| | - Rose Gubitosi-Klug
- Case Western Reserve University, Cleveland OH, United States
- University Hospitals Rainbow Babies and Children’s Hospital, Cleveland OH, United States
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16
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Marlow AL, King BR, Trost SG, Weaver N, Smart CE. Healthy weight and overweight adolescents with type 1 diabetes mellitus do not meet recommendations for daily physical activity and sleep. Diabetes Res Clin Pract 2023; 203:110879. [PMID: 37591344 DOI: 10.1016/j.diabres.2023.110879] [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: 06/11/2023] [Revised: 08/11/2023] [Accepted: 08/14/2023] [Indexed: 08/19/2023]
Abstract
AIMS Physical activity (PA) plays an important role in the prevention of cardiovascular disease (CVD), particularly in individuals with type 1 diabetes mellitus (T1DM) who are at increased risk. Our aim was to determine levels of moderate-to-vigorous physical activity (MVPA), sedentary behaviour and sleep in adolescents with T1DM, and identify barriers to PA. METHODS Participants aged 12-18 with T1DM wore an accelerometer and continuous glucose monitor for 24 h over 7-days. Data was processed into PA metrics and sleep. Pearson correlations were used to test associations between MVPA and metabolic measures. Barriers to PA were measured using a questionnaire. RESULTS Thirty-seven adolescents provided valid accelerometer data. Mean daily MVPA was 44.0 min [SD 17.6] with 16.2% achieving the guideline of ≥ 60 min/day. Participants had 11 h [SD 1.2] of sedentary behaviour and 7.6 h [SD 1.5] of sleep/day. There was no difference in MVPA in overweight or obese (53.8%) vs. healthy weight (44.2%) adolescents (45.0 min [SD 16.6] vs. 43.1 min [SD 18.8]). Only 39.6% reported one or more diabetes specific barrier to PA. CONCLUSION Adolescents with T1DM engage in insufficient MVPA and sleep, irrespective of body weight status, suggesting the need for targeted interventions.
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Affiliation(s)
- Alexandra L Marlow
- School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
| | - Bruce R King
- School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia; Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, New South Wales, Australia.
| | - Stewart G Trost
- School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Australia; School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia.
| | - Natasha Weaver
- School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
| | - Carmel E Smart
- School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia; Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, New South Wales, Australia.
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Hauschild M, Monnard C, Eldridge AL, Antoniou MC, Bouthors T, Hansen E, Dwyer AA, Rytz A, Darimont C. Glucose variability in 6-12-month-old healthy infants. Front Nutr 2023; 10:1128389. [PMID: 37502727 PMCID: PMC10369064 DOI: 10.3389/fnut.2023.1128389] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2022] [Accepted: 06/15/2023] [Indexed: 07/29/2023] Open
Abstract
Background Metabolic programming of glucose homeostasis in the first 1,000 days of life may impact lifelong metabolic and cardiovascular health. Continuous glucose monitoring (CGM) devices may help measure the impact of dietary intake on glucose rhythms and metabolism in infants during the complementary feeding period. Objectives Demonstrate the feasibility of CGM to measure and quantify glucose variability in response to infant feeding and to evaluate associations between macronutrient meal composition and glucose variability. Methods The "FreeStyle Libre Pro®" device interstitial glucose meter was applied to the anterior thigh of 10 healthy 6-12-month-old infants. Parents recorded food intake, time of feeding, and used daily dairies to record sleep time and duration. Descriptive statistics were employed for food intake, sleep and key glycemic parameters over three full days. Mixed linear models were used to assess glycemic changes. Results Mid-day, afternoon, and evening feeds contained >30 g carbohydrate and induced higher 2-h iAUC (3.42, 3.41, and 3.50 mmol/L*h respectively) compared to early and mid-morning feedings with ≤25 g carbohydrates (iAUC 2.72 and 2.81 mmol/L*h, p < 0.05). Early morning and evening milk feedings contained approximately 9 g of fat and induced a longer time to reach maximal glucose value (Tmax; 75 and 68 min, respectively) compared to lower fat feedings (2.9-5.9 g; Tmax range: 34-60 min; p < 0.05). Incremental glucose value at time of food intake (C0) increased significantly from 0.24 ± 0.39 mM in early morning to 1.07 ± 0.57 mM in the evening (p < 0.05). Over the day, 70% of glucose values remained within the normal range (3.5-5.5 mmol/L), 10% were between 5.5-10 mmol/L, and 20% were < 3.5 mmol/L. Conclusion Our data support the feasibility of using CGM to measure glucose in 6-12-month-old infants. The observation of possible diurnal glucose variability and typical glucose values may have implications for future studies investigating metabolic adaptation to nutritional intake in early life.
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Affiliation(s)
- Michael Hauschild
- Pediatric Endocrinology, Diabetes and Obesity Unit, Department Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
| | - Cathriona Monnard
- Nestlé Institute of Health Sciences, Nestlé Research, Lausanne, Switzerland
| | - Alison L. Eldridge
- Nestlé Institute of Health Sciences, Nestlé Research, Lausanne, Switzerland
| | - Maria Christina Antoniou
- Pediatric Endocrinology, Diabetes and Obesity Unit, Department Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
| | - Thérèse Bouthors
- Pediatric Endocrinology, Diabetes and Obesity Unit, Department Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
| | - Erik Hansen
- Pediatric Endocrinology, Diabetes and Obesity Unit, Department Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
| | - Andrew A. Dwyer
- Boston College, William F. Connell School of Nursing, Chestnut Hill, MA, United States
| | - Andreas Rytz
- Clinical Research Unit, Nestlé Research, Lausanne, Switzerland
| | - Christian Darimont
- Nestlé Institute of Health Sciences, Nestlé Research, Lausanne, Switzerland
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18
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Afeef S, Tolfrey K, Zakrzewski-Fruer JK, Barrett LA. Performance of the FreeStyle Libre Flash Glucose Monitoring System during an Oral Glucose Tolerance Test and Exercise in Healthy Adolescents. SENSORS (BASEL, SWITZERLAND) 2023; 23:s23094249. [PMID: 37177452 PMCID: PMC10180860 DOI: 10.3390/s23094249] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Revised: 04/19/2023] [Accepted: 04/21/2023] [Indexed: 05/15/2023]
Abstract
This study's aim was to assess FreeStyle Libre Flash glucose monitoring (FGM) performance during an oral glucose tolerance test (OGTT) and treadmill exercise in healthy adolescents. This should advance the feasibility and utility of user-friendly technologies for metabolic assessments in adolescents. Seventeen healthy adolescents (nine girls aged 12.8 ± 0.9 years) performed an OGTT and submaximal and maximal treadmill exercise tests in a laboratory setting. The scanned interstitial fluid glucose concentration ([ISFG]) obtained by FGM was compared against finger-prick capillary plasma glucose concentration ([CPG]) at 0 (pre-OGTT), -15, -30, -60, -120 min post-OGTT, pre-, mid-, post- submaximal exercise, and pre- and post- maximal exercise. Overall mean absolute relative difference (MARD) was 13.1 ± 8.5%, and 68% (n = 113) of the paired glucose data met the ISO 15197:2013 criteria. For clinical accuracy, 84% and 16% of FGM readings were within zones A and B in the Consensus Error Grid (CEG), respectively, which met the ISO 15197:2013 criteria of having at least 99% of results within these zones. Scanned [ISFG] were statistically lower than [CPG] at 15 (-1.16 mmol∙L-1, p < 0.001) and 30 min (-0.74 mmol∙L-1, p = 0.041) post-OGTT. Yet, post-OGTT glycaemic responses assessed by total and incremental areas under the curve (AUCs) were not significantly different, with trivial to small effect sizes (p ≥ 0.084, d = 0.14-0.45). Further, [ISFGs] were not different from [CPGs] during submaximal and maximal exercise tests (interaction p ≥ 0.614). FGM can be a feasible alternative to reflect postprandial glycaemia (AUCs) in healthy adolescents who may not endure repeated finger pricks.
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Affiliation(s)
- Sahar Afeef
- School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK
- Clinical Nutrition Department, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah 21589, Saudi Arabia
| | - Keith Tolfrey
- School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK
| | - Julia K Zakrzewski-Fruer
- Institute for Sport and Physical Activity Research, University of Bedfordshire, Bedford MK41 9EA, UK
| | - Laura A Barrett
- School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK
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Pemberton JS, Wilmot EG, Barnard-Kelly K, Leelarathna L, Oliver N, Randell T, Taplin CE, Choudhary P, Adolfsson P. CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review. Diabetes Obes Metab 2023; 25:916-939. [PMID: 36585365 DOI: 10.1111/dom.14962] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2022] [Revised: 12/12/2022] [Accepted: 12/23/2022] [Indexed: 01/01/2023]
Abstract
The National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. Manufacturers can trade in the UK with Conformité Européenne (CE) marking without an initial national assessment. The regulatory process for CGM CE marking, in contrast to the Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) process, is described. Manufacturers operating in the UK provided clinical accuracy studies submitted for CE marking. Critical appraisal of the studies shows several CGM devices have CE marking for wide-ranging indications beyond available data, unlike FDA and TGA approval. The FDA and TGA use tighter controls, requiring comprehensive product-specific clinical data evaluation. In 2018, the FDA published the integrated CGM (iCGM) criteria permitting interoperability. Applying the iCGM criteria to clinical data provided by manufacturers trading in the UK identified several study protocols that minimized glucose variability, thereby improving CGM accuracy on all metrics. These results do not translate into real-life performance. Furthermore, for many CGM devices available in the UK, accuracy reported in the hypoglycaemic range is below iCGM standards, or measurement is absent. We offer a framework to evaluate CGM accuracy studies critically. The review concludes that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications can have discrepancies. The UK can bolster regulation with UK Conformity Assessed marking from January 2025. However, balanced regulation is needed to ensure innovation and timely technological access are not hindered.
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Affiliation(s)
- John S Pemberton
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's, and Children's NHS Foundation Trust, Birmingham, UK
| | - Emma G Wilmot
- University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
- University of Nottingham, Nottingham, UK
| | | | - Lalantha Leelarathna
- Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
- Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Nick Oliver
- Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK
| | | | - Craig E Taplin
- Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia
- Telethon Kids Institute, University of Western Australia, Perth, Australia
- Centre for Child Health Research, University of Western Australia, Perth, Australia
| | - Pratik Choudhary
- Leicester Diabetes Center, University of Leicester, Leicester, UK
| | - Peter Adolfsson
- Department of Paediatrics, Kungsbacka Hospital; Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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20
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Abulqasim J, Alotaibi F, Al Khalifah RA. Safety and user experience with off-label use of a flash glucose monitor (FreeStyle Libre ® 1) among very young children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2023; 36:119-125. [PMID: 36595216 DOI: 10.1515/jpem-2022-0452] [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: 09/08/2022] [Accepted: 12/15/2022] [Indexed: 01/04/2023]
Abstract
OBJECTIVES FreeStyle Libre 1 (FGM) has been approved by the FDA for children older than 4 years. It enables noninvasive glucose monitoring without the need for finger pricking. Parents of very young children often use the device off-label. Thus, we aimed to evaluate the safety of and user experience with FreeStyle Libre® 1 and determine its impact on sleep and glycemic control. METHODS This was an ambi-directional cohort study. We recruited parents of very young children with type 1 diabetes mellitus (T1DM) who were less than 5 years old when they started using FGM at the King Saud University Diabetes Center. The parents filled out a survey evaluating their experience with the system. In addition, the glucose metrics of the children were also obtained from the Libre View system. RESULTS We included 31 children with mean age of the children when they started using FGM was 3.88 ± 1.10 years (range, 1.46-5.4 years), and the mean sensor use was 2.3 ± 1.3 years. During the use of the device, the parents had increased sleep duration of 0.71 h (p-value=0.04), had earlier bedtime by 2.8 h (p-value=0.04), and were able to sleep in a separate room from their children. In addition, the time in range improved by 9.9%, the time above range decreased by 8.8%, and the HbA1c level reduced by 1.56%. CONCLUSIONS The safety profile of FGM used for very young children with T1DM is the same for older children, which leads to improved metabolic control and sleep quality of both the parent and the child.
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Affiliation(s)
- Jumana Abulqasim
- Pediatric Endocrine Division, Department of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Fahad Alotaibi
- Pediatric Endocrine Division, Department of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Reem Abdullah Al Khalifah
- Pediatric Endocrine Division, Department of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia.,University Diabetes Center, King Saud University Medical City, Riyadh, Saudi Arabia
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21
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Diéguez E, Nieto-Ruiz A, Sepúlveda-Valbuena N, Herrmann F, Agil A, De-Castellar R, Jiménez J, Azaryah H, García-Santos JA, García-Bermúdez M, Campoy C. Long-Term Effects and Potential Impact of Early Nutrition with Breast Milk or Infant Formula on Glucose Homeostasis Control in Healthy Children at 6 Years Old: A Follow-Up from the COGNIS Study. Nutrients 2023; 15:852. [PMID: 36839210 PMCID: PMC9965004 DOI: 10.3390/nu15040852] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2023] [Revised: 01/31/2023] [Accepted: 02/03/2023] [Indexed: 02/10/2023] Open
Abstract
There is scarce evidence about early nutrition programming of dynamic aspects of glucose homeostasis. We analyzed the long-term effects of early nutrition on glycemic variability in healthy children. A total of 92 children participating in the COGNIS study were considered for this analysis, who were fed with: a standard infant formula (SF, n = 32), an experimental formula (EF, n = 32), supplemented with milk fat globule membrane (MFGM) components, long-chain polyunsaturated fatty acids (LC-PUFAs), and synbiotics, or were breastfed (BF, n = 28). At 6 years old, BF children had lower mean glucose levels and higher multiscale sample entropy (MSE) compared to those fed with SF. No differences in MSE were found between EF and BF groups. Normal and slow weight gain velocity during the first 6 months of life were associated with higher MSE at 6 years, suggesting an early programming effect against later metabolic disorders, thus similarly to what we observed in breastfed children. Conclusion: According to our results, BF and normal/slow weight gain velocity during early life seem to protect against glucose homeostasis dysregulation at 6 years old. EF shows functional similarities to BF regarding children's glucose variability. The detection of glucose dysregulation in healthy children would help to develop strategies to prevent the onset of metabolic disorders in adulthood.
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Affiliation(s)
- Estefanía Diéguez
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Instituto de Investigación Biosanitaria (ibs.GRANADA), Health Sciences Technological Park, 18012 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
| | - Ana Nieto-Ruiz
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Instituto de Investigación Biosanitaria (ibs.GRANADA), Health Sciences Technological Park, 18012 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
| | - Natalia Sepúlveda-Valbuena
- Nutrition and Biochemistry Department, Faculty of Sciences, Pontificia Universidad Javeriana, Bogotá 110231, Colombia
| | - Florian Herrmann
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
| | - Ahmad Agil
- Department of Pharmacology, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Federico Oloriz Neuroscience Institute, University of Granada, 18016 Granada, Spain
| | | | - Jesús Jiménez
- Ordesa Laboratories, 08830 Sant Boi de Llobregat, Spain
| | - Hatim Azaryah
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Instituto de Investigación Biosanitaria (ibs.GRANADA), Health Sciences Technological Park, 18012 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
| | - José Antonio García-Santos
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Instituto de Investigación Biosanitaria (ibs.GRANADA), Health Sciences Technological Park, 18012 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
| | - Mercedes García-Bermúdez
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Instituto de Investigación Biosanitaria (ibs.GRANADA), Health Sciences Technological Park, 18012 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
| | - Cristina Campoy
- Department of Paediatrics, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Instituto de Investigación Biosanitaria (ibs.GRANADA), Health Sciences Technological Park, 18012 Granada, Spain
- EURISTIKOS Excellence Centre for Paediatric Research, Biomedical Research Centre, Faculty of Medicine, University of Granada, 18016 Granada, Spain
- Federico Oloriz Neuroscience Institute, University of Granada, 18016 Granada, Spain
- National Network of Research in Epidemiology and Public Health (CIBERESP), Institute of Health Carlos III (Granada’s node), 28029 Madrid, Spain
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22
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Matheus ASM, Pascoal JBF, Cabizuca CA, Tannus LRM, Guimarães RS, Mattos DMF, Cobas RA. Flash glucose monitoring system in patients with type 1 diabetes in healthcare center in Brazil: real world data from a short-term prospective study. ARCHIVES OF ENDOCRINOLOGY AND METABOLISM 2022; 67:289-297. [PMID: 36468924 DOI: 10.20945/2359-3997000000540] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Objective To evaluate the alternate use of flash glucose monitoring (FGM) with self-monitoring blood glucose (SMBG), in patients with type 1 diabetes (T1D). Materials and methods Two weeks of open FGM (P2), both preceded (P1) and followed by 2 weeks (P3) of SMBG with a blinded FGM system. Mean absolute relative difference (MARD) was calculated by (|FGMi - SMBGi|) / SMBGi, where it was a paired data sample. Results In total, 34 patients were evaluated. Time in range (TIR) did not change between P1 and P2. In 12 patients (35.3%), TIR increased from 40% at P1 to 52% at P2 (p = 0.002) and in 22 (64.7%), TIR decreased or did not change. FGM use resulted in decreased % time spent in hypoglycemia (<70 mg/dL) (6.5% vs. 5.0%; p = 0.005), increased % time spent in hyperglycemia (>180 mg/dL) (44.5% to 51%; p = 0.046) with no significant change in % TIR. The proportion of patients who reached sensor-estimated glycated hemoglobin (eA1c) < 7% decreased from 23.5% at P1 to 12.9% at P2, p = 0.028. For the whole sample, the MARD between the two methods was 15.5% (95% CI 14.5-16.6%). For normal glucose range, hyperglycemic levels and hypoglycemic levels MARD were 16.0% (95% CI 15.0-17.0%), 13.3% (95% CI 11.5-15.2%) and 23.4% [95% CI 20.5-26.3%)], respectively. Conclusion FGM after usual SMBG decreased the % time spent in hypoglycemia concomitant with an undesired increase in % time spent in hyperglycemia. Lower accuracy of FGM regarding hypoglycemia levels could result in overcorrection of hypoglycemia.
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23
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Al Hayek AA, Alwin Robert A, Al Dawish MA. Flash Glucose Monitoring System facilitates sustainable improvements in glycemic control in patients with type 1 diabetes: A 12-month follow-up study in real life. Diabetes Metab Syndr 2022; 16:102620. [PMID: 36150328 DOI: 10.1016/j.dsx.2022.102620] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2022] [Revised: 09/07/2022] [Accepted: 09/12/2022] [Indexed: 10/14/2022]
Abstract
BACKGROUND AND AIMS Examine the glycemic control on Type 1 Diabetes (T1D) wearing the Flash Glucose Monitoring (FGM) system for a one-year period of time. METHODS This prospective study done using 187 patients with T1D (14-40yrs) who self-tested their glucose levels by FGM. Continuous glucose monitoring (CGM) metrics were gathered i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events at the 3, 6, and 12 month time periods. RESULTS At 6th, 9th and 12th months, for values of GV, % in target, TAR and %>250 mg/dL, no significant changes (p > 0.05) were noted compared to 3 months. However, significant changes from the baseline were evident for the values of the mean glucose level at the 3rd (p = 0.028), 9th (p = 0.048) and 12th months (p = 0.022). When the mean glucose value at 3 months was compared to the same at 6, 9, and 12 month period, no significant changes (p > 0.05) were seen. When compared with baseline values, low glucose events at 3 months (p = 0.028), 6 months (p = 0.048), 9 months (p = 0.022) and 12 months (p = 0.038) showed significant changes. However, the percentage below 70 mg/dL (barring the value at 12 months, p = 0.046), no significant changes were observed. The HbA1c revealed significant drop in 3, 6, 9 and 12 months compared to baseline values. CONCLUSION Significant improvement was noted in CGM metrics when patients switched from conventional finger pricking method over to FGM system, and the effect was observed during the entire study period.
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Affiliation(s)
- Ayman Abdullah Al Hayek
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
| | - Asirvatham Alwin Robert
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
| | - Mohamed Abdulaziz Al Dawish
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
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Leiva-Gea I, Porcel Chacón R, Ariza Jiménez AB, Mora Loro M, Tapia-Ceballos L, Jiménez-Hinojosa J, Gómez Perea A, López Siguero JP. Impacto en hipoglucemia grave y costes sanitarios del uso del sistema FreeStyle en población pediátrica con diabetes mellitus tipo 1. ENDOCRINOL DIAB NUTR 2022. [DOI: 10.1016/j.endinu.2021.10.010] [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: 11/29/2022]
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25
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Leiva-Gea I, Porcel Chacón R, Ariza Jiménez AB, Mora Loro M, Tapia-Ceballos L, Jiménez-Hinojosa J, Gómez Perea A, López Siguero JP. Impact on variables of severe hypoglycaemia and healthcare costs of the use of the FreeStyle system in paediatric population with type 1 diabetes mellitus. ENDOCRINOL DIAB NUTR 2022; 69:561-565. [PMID: 36347794 DOI: 10.1016/j.endien.2021.10.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/07/2021] [Accepted: 10/03/2021] [Indexed: 06/16/2023]
Abstract
INTRODUCTION Analysis of the impact on severe hypoglycaemia and direct costs of the introduction of the FreeStyle Libre sensor in paediatric population with type 1 Diabetes Mellitus. MATERIAL AND METHODS Ambispective single-centre study to assess the impact on severe hypoglycaemia and direct costs, focusing on consumption of materials, in paediatric population with type 1 Diabetes Mellitus before and after introduction of the FreeStyle Libre 1 sensor. RESULTS A significant decrease was found in episodes of severe hypoglycaemia, with 4.2 episodes of severe hypoglycaemia per 100 patients under follow-up versus 0.25 episodes per 100 patients a year after introduction of the system. This represents a cost difference for severe hypoglycaemia, estimated at €6559.52 before introduction and €409.97 after introduction of the FreeStyle Libre sensor. We found a decrease in the daily consumption of capillary blood glucose strips, which translates as a decrease in the cost of materials and helps mitigate the cost of the sensor. The cost in materials for the patient with FreeStyle Libre was €185.13 per patient and year higher than conventional control with capillary blood glucose strips.
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Affiliation(s)
- Isabel Leiva-Gea
- Hospital Regional Universitario de Málaga, Málaga, Spain; Instituto de Biomedicina de Málaga (IBIMA), Málaga, Spain
| | | | | | | | - Leopoldo Tapia-Ceballos
- Hospital Regional Universitario de Málaga, Málaga, Spain; Instituto de Biomedicina de Málaga (IBIMA), Málaga, Spain
| | | | - Ana Gómez Perea
- Hospital Regional Universitario de Málaga, Málaga, Spain; Instituto de Biomedicina de Málaga (IBIMA), Málaga, Spain
| | - Juan Pedro López Siguero
- Hospital Regional Universitario de Málaga, Málaga, Spain; Instituto de Biomedicina de Málaga (IBIMA), Málaga, Spain
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Urakami T. Significance of the CGM metric of time in range in children and adolescents with type 1 diabetes. Endocr J 2022; 69:1035-1042. [PMID: 36002301 DOI: 10.1507/endocrj.ej22-0257] [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: 11/23/2022] Open
Abstract
Continuous glucose monitoring (CGM) has been widely used in children and adolescents as well as adults with type 1 diabetes. CGM metrics include three key measurements of target glucose: time in range (TIR: 70-180 mg/dL), time below range (TBR: <70 mg/dL), and time above range (TAR: >180 mg/dL). The primary goal of optimal glycemic control is to increase TIR to more than 70%, while simultaneously reducing TBR to less than 4%, while minimizing severe hypoglycemia to less than 1%, as proposed by the Advanced Technologies and Treatments for Diabetes (ATTD) panel. However, several studies have indicated that the TIR goal is quite difficult to achieve in pediatric patients who have remarkable interindividual and day-to-day glycemic variation due to their irregular lifestyles. Previous studies have demonstrated that patients without an automated insulin delivery system are unlikely to attain the recommended glycemic goals. On the other hand, reduction of hypoglycemia, particularly minimizing severe hypoglycemia, is a critical issue in the effective management of children with type 1 diabetes. Frequent episodes of severe hypoglycemia and hypoglycemia can cause lasting neurological damage. Accordingly, we propose reducing the TBR to less than 5%, rather than just targeting the TIR to more than 70%. In CGM metrics this should be the cardinal glycemic goal for pediatric patients who are either being treated with multiple daily injections of insulin or a conventional insulin pump, but who are not using an automated insulin delivery system.
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Affiliation(s)
- Tatsuhiko Urakami
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo 173-8610, Japan
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27
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Li Y, Cao B, Chen Q, Du M, Yan M, Chen Y, Wei H, Wu X, Cui Y, Liu F. Application of the FreeStyle®Libre Glucose Monitoring System in type 1 diabetes mellitus patients aged 1-4 years. Pediatr Diabetes 2022; 23:604-610. [PMID: 35644029 DOI: 10.1111/pedi.13368] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/01/2021] [Revised: 05/01/2022] [Accepted: 05/26/2022] [Indexed: 11/30/2022] Open
Abstract
BACKGROUND To investigate the analytical accuracy, safety performance, and user satisfaction (guardians of study participants) of the FreeStyle®Libre Glucose Monitoring System in the treatment of type 1 diabetes mellitus (T1DM), in children aged <4 years. METHODS Sixteen hospitalized children with new onset T1DM, aged 4 months to 4 years, were enrolled in this study. Patients wore the sensor for 14 days; sensor scans were performed immediately and at 5, 10, and 15 min after capillary blood glucose (BG) measurements to evaluate the effectiveness of the device and the lag effect. RESULTS The consensus error grid showed that 96.40% of values fell within zone A (no clinical impact) and 3.60% within zone B (little/no clinical impact). Overall, the mean absolute relative difference (MARD) was 9.34%, and was higher in the capillary BG <4.0 mmol/L group (15.18%) than in the 4-10 mmol/L (9.63%) and >10 mmol/L (7.17%) groups. The MARD increased gradually with scanning time extension, indicating a short lag effect. Regression analysis showed that a higher BG level was associated with a greater difference in FreeStyle®Libre System measurements. CONCLUSIONS The use of the FreeStyle®Libre System in children aged 1-4 years is accurate and safe, and may be accurate down to 4 months, independent of patient characteristics.
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Affiliation(s)
- Yangshiyu Li
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Bingyan Cao
- Department of Endocrinology, Genetic and Metabolism, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China
| | - Qiong Chen
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Mengmeng Du
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Mingming Yan
- Department of Statistics and Epidemiology, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Yongxing Chen
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Haiyan Wei
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Xue Wu
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Yan Cui
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
| | - Fang Liu
- Department of Endocrinology, Genetics and Metabolism, Henan Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China
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Alharbi MY, Albunyan A, Al Nahari A, Al Azmi F, Alenazi B, Al Harbi T, Al Malki M, Al Ahmadi H. Measuring the Impact of Flash Glucose Monitoring in a Pediatric Population in Saudi Arabia: A Retrospective Cohort Study. Diabetes Ther 2022; 13:1139-1146. [PMID: 35441933 PMCID: PMC9174401 DOI: 10.1007/s13300-022-01224-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/20/2021] [Accepted: 02/02/2022] [Indexed: 11/26/2022] Open
Abstract
INTRODUCTION Measurement of glucose levels is the mainstay method of ensuring good glycemic control and preventing complications associated with uncontrolled diabetes. Continuous glucose monitoring enables easy and effective monitoring of interstitial glucose around the clock and hence improves glycemic control. OBJECTIVES This study aimed to measure the effect of continuous glucose monitoring on glycated hemoglobin (HbA1c) at 3, 6, and 9 months following sensor insertion. METHODS A retrospective cohort study of pediatric and adolescent type 1 diabetes mellitus patients randomly sampled from 32 Ministry of Health diabetes centers across Saudi Arabia was performed. Patients were subjected to flash glucose monitoring using the FreeStyle® Libre flash glucose monitoring system (Abbott Diabetes Care, Witney, UK), an intermittently scanned continuous glucose monitoring device approved by the Conformité Européenne in 2014. These patients were first-time users of any kind of continuous glucose monitoring system, aged 4-18 years, and received insulin via multiple dose injection or continuous subcutaneous insulin infusion for at least 6 months prior to study start. Patients were excluded if they had used flash glucose monitoring or other interstitial glucose monitoring systems in the past 3 months, were pregnant, or had existing hemoglobinopathies. The flash glucose monitoring sensor was attached to the back of the upper arm at the baseline visit. HbA1c (%) was measured at baseline and 3, 6, and 9 months. Patient demographics were collected from electronic health records. RESULTS 1,307 patients were included, with a mean age of 11.1 years (standard deviation 3.6 years). Where specified, 51.4% were female. Mean HbA1c significantly reduced from baseline (10.8%) to 3 months (9.8%, p < 0.001), 6 months (9.2%, p < 0.001), and 9 months (9.1%, p < 0.001). For individuals with baseline HbA1c > 9%, mean HbA1c was significantly reduced from baseline (11.7%) to 3 months (10.3%, p < 0.001), 6 months (9.6%, p < 0.001), and 9 months (9.5%, p < 0.001). CONCLUSIONS Flash glucose monitoring significantly reduced HbA1c levels at 3, 6, and 9 months following sensor insertion. This reduction was greatest in those patients with higher HbA1c at baseline (> 9%).
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Affiliation(s)
- Mohammed Y Alharbi
- Therapeutic Services Deputyship, Ministry of Health, Riyadh, 11176, Kingdom of Saudi Arabia.
| | - Abdulhameed Albunyan
- Pediatric Department, Maternity and Children Hospital, Al Hasa, Kingdom of Saudi Arabia
| | | | - Fayez Al Azmi
- Alqurayyat Diabetes Center, Al Qurayyat, Kingdom of Saudi Arabia
| | - Badi Alenazi
- Pediatric Department, Alyammah Hospital, Riyadh, Kingdom of Saudi Arabia
| | - Tayba Al Harbi
- Maternity and Children Hospital, Makkah, Kingdom of Saudi Arabia
| | - Matar Al Malki
- Maternity and Children Hospital, Taif, Kingdom of Saudi Arabia
| | - Husam Al Ahmadi
- Maternity and Children Hospital, Qassim, Kingdom of Saudi Arabia
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Tsotridou E, Kotzapanagiotou E, Violaki A, Dimitriadou M, Svirkos M, Mantzafleri PE, Papadopoulou V, Sdougka M, Christoforidis A. The Effect of Various, Everyday Practices on Glucose Levels in Critically Ill Children. J Diabetes Sci Technol 2022; 16:81-87. [PMID: 33025823 PMCID: PMC8875055 DOI: 10.1177/1932296820959315] [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: 11/16/2022]
Abstract
BACKGROUND To evaluate the effect of various, everyday intensive care unit (ICU) practices on glucose levels in critically ill pediatric patients with the use of a continuous glucose monitoring system. METHODS Seventeen sensors were placed in 16 pediatric patients (8 male). All therapeutic and diagnostic interventions were recorded and 15 minutes later, a flash glucose measurement was obtained by swiping the sensor with a reader. Glucose difference was calculated as the glucose value 15 minutes after the intervention minus the mean daily glucose value for each individual patient. Additionally, the consciousness status of the patient (awake or sedated) was recorded. RESULTS Two hundred and five painful skin interventions were recorded. The mean difference of glucose values was higher by 1.84 ± 14.76 mg/dL (95% CI: -0.19 to 3.87 mg/dL, P = .076). However, when patients were categorized regarding their consciousness level, mean glucose difference was significantly higher in awake state than in sedated patients (4.76 ± 28.07 vs -2.21 ± 15.77 mg/dL, P < .001). Six hundred forty-nine interventions involving the respiratory system were recorded. Glucose difference during washings proved to be significantly higher than the ones during simple suctions (4.74 ± 14.18 mg/dL vs 0.32 ± 18.22 mg/dL, P = .016). Finally, glucose difference in awake patients was higher by 3.66 ± 13.91 mg/dL compared to glucose difference of -2.25 ± 21.07 mg/dL obtained during respiratory intervention in sedated patients. CONCLUSIONS Diagnostic and therapeutic procedures in the ICU, especially when performed in an awake state, exacerbate the stress and lead to a significant rise in glucose levels.
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Affiliation(s)
- Eleni Tsotridou
- 1st Department of Pediatrics, Aristotle University, Ippokratio General Hospital, Thessaloniki, Greece
| | | | - Asimina Violaki
- Pediatric Intensive Care Unit, Ippokratio General Hospital, Thessaloniki, Greece
| | - Meropi Dimitriadou
- 1st Department of Pediatrics, Aristotle University, Ippokratio General Hospital, Thessaloniki, Greece
| | - Menelaos Svirkos
- Pediatric Intensive Care Unit, Ippokratio General Hospital, Thessaloniki, Greece
| | | | | | - Maria Sdougka
- Pediatric Intensive Care Unit, Ippokratio General Hospital, Thessaloniki, Greece
| | - Athanasios Christoforidis
- 1st Department of Pediatrics, Aristotle University, Ippokratio General Hospital, Thessaloniki, Greece
- Athanasios Christoforidis, MD, PhD, 1st Department of Pediatrics, Aristotle University of Thessaloniki, 49 Konstantinoupoleos Str, Thessaloniki 54642, Greece.
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Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne) 2022; 13:870916. [PMID: 35712259 PMCID: PMC9193969 DOI: 10.3389/fendo.2022.870916] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2022] [Accepted: 04/12/2022] [Indexed: 11/13/2022] Open
Abstract
OBJECTIVE To compare glycemic control and treatment preference in children with type 1 diabetes (T1D) using sensor augmented pump (SAP) with predictive low glucose suspend (SmartGuard®) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre ®). METHODS In this open label, cross-over study, children 6 to 14 years of age, treated with insulin pump for at least 6 months, were randomized to insulin pump and iscCGM (A) or SAP with SmartGuard® (B) for 5 weeks followed by 5 additional weeks. The difference in percentages of time in glucose target (TIT), (3.9 - 8.0 mmol/l), <3 mmol/l, > 8 and 10 mmol/l, were analyzed using linear mixed models during the final week of each arm and were measured by blinded CGM (IPro2®). RESULTS 31 children (15 girls) finished the study. With sensor compliance > 60%, no difference in TIT was found, TIT: A 37.86%; 95% CI [33.21; 42.51]; B 37.20%; 95% CI [32.59; 41.82]; < 3 mmol/l A 2.27% 95% CI [0.71; 3.84] B 1.42% 95% CI [-0.13; 2.97]; > 8 mmol/l A 0.60% 95% CI [0.56, 0.67]; B 0.63% [0.56; 0.70]. One year after the study all participants were on CGM compared to 80.7% prior to the study, with a shift of 13/25 participants from iscCGM to SAP. CONCLUSIONS In this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard®) or pump with iscCGM. The decision of all families to continue with CGM after the study suggests a positive impact, with preference for SmartGuard®. CLINICAL TRIAL REGISTRATION [clinicaltrials.gov], identifier NCT03103867.
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Affiliation(s)
- Ulrike Schierloh
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg
- *Correspondence: Ulrike Schierloh,
| | - Gloria A. Aguayo
- Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, Luxembourg
| | - Anna Schritz
- Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg
| | - Muriel Fichelle
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg
| | - Cindy De Melo Dias
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg
| | - Michel T. Vaillant
- Competence Center for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg
| | - Ohad Cohen
- Institute of Endocrinology, Sheba Medical Center, Tel Hashomer, Israel
| | - Inge Gies
- Pediatric Endocrinology, KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium
| | - Carine de Beaufort
- Department of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg
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31
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Mohamed IAA, Talaat IM, Alghamdi HA, Allam G. Role of free style Libre-Flash Glucose Monitoring: Glycemic control of Type-1 Diabetes. Pak J Med Sci 2021; 37:1883-1889. [PMID: 34912412 PMCID: PMC8613028 DOI: 10.12669/pjms.37.7.4114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2021] [Revised: 03/30/2021] [Accepted: 06/05/2021] [Indexed: 11/15/2022] Open
Abstract
Background & Objective Type-1 diabetics (T1D) usually do not meet guidelines for glycaemic control. This study aimed to determine the benefit of free style libre-flash glucose monitoring system (FSL-FGM) in lowering glycated hemoglobin (HbA1c) in poorly controlled T1D patients. Methods This prospective two single arm clinical study included 273 T1D patients, and data collected at one, six and 18 months with concomitant extraction of samples for HbA1c basal and at six and 18 months. The study was conducted in Prince Mansour Military Hospital at Taif, Saudi Arabia from June 2017 to November 2018. Results HbA1c % was significantly diminished in patients used FSL-FGM at 6 and 18 months. The median percentage difference in HbA1c at 6 and 18 months versus basal was significantly decreased in those using FSL-FGM. Within diabetics using FSL-FGM, the median difference in HbA1c after 18 months was significantly decreased in patients with HbA1c >10% compared to those with HbA1c <10%. Estimated HbA1c by FSL showed a significant correlation with HbA1C assayed in the blood. The snapshot information showed a highly significant difference in average glucose with low significant difference in hypoglycemia parameters. The FSL-FGM provides significant changes in HbA1c in diabetic patients without observed risk for hypoglycemia. Conclusions The dynamic way of blood glucose monitoring using FSL-FGM provides improvement in HbA1c in diabetic patients without observed risk for hypoglycemia.
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Affiliation(s)
- Imad A A Mohamed
- Imad A.A. Mohamed, Department of Microbiology, College of Medicine, Taif University, Taif, Saudi Arabia
| | - Iman M Talaat
- Iman M. Talaat, Dept. of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Diabetes Endocrine Specialist Center, Prince Mansour Military Hospital, Taif, Saudi Arabia
| | - Hamed A Alghamdi
- Hamed A. Alghamdi, Academic Medical Center, Prince Mansour Military Hospital, Taif, Saudi Arabia
| | - Gamal Allam
- Gamal Allam, Department of Microbiology, College of Medicine, Taif University, Taif, Saudi Arabia
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Styles S, Wheeler B, Boucsein A, Crocket H, de Lange M, Signal D, Wiltshire E, Cunningham V, Lala A, Cutfield W, de Bock M, Serlachius A, Jefferies C. A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol. J Diabetes Metab Disord 2021; 20:2093-2101. [PMID: 34900845 PMCID: PMC8630241 DOI: 10.1007/s40200-021-00907-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/01/2021] [Accepted: 09/23/2021] [Indexed: 11/26/2022]
Abstract
Purpose Frequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.K.) to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control. Methods This open-label randomised controlled trial will enrol 100 children (4–13 years inclusive, diagnosis of type 1 diabetes ≥ 6 months, HbA1c 58–110 mmol/mol [7.5–12.2%]), from 5 New Zealand diabetes centres. Following 2 weeks of blinded sensor wear, children will be randomised 1:1 to control or intervention arms. The intervention (duration 12 weeks) includes second-generation isCGM (FreeStyle Libre 2) and education on using interstitial glucose data to manage diabetes. The control group will continue self-monitoring blood glucose. The primary outcome is the difference in glycaemic control (measured as HbA1c) between groups at 12 weeks. Pre-specified secondary outcomes include change in glucose monitoring frequency, glycaemic control metrics and psychosocial outcomes at 12 weeks as well as isCGM acceptability. Discussion This research will investigate the effectiveness of the second-generation isCGM to promote recommended glycaemic control. The results of this trial may have important implications for including this new technology in the management of children with type 1 diabetes. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).
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Affiliation(s)
- Sara Styles
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
| | - Ben Wheeler
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.,Paediatrics, Southern District Health Board, Dunedin, New Zealand.,Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand
| | - Alisa Boucsein
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Hamish Crocket
- Health, Sport and Human Performance, School of Health, University of Waikato, Hamilton, New Zealand
| | - Michel de Lange
- Centre for Biostatistics, Te Pokapū Tatauranga Koiora, Division of Health Sciences, Dunedin, New Zealand
| | - Dana Signal
- Paediatric Diabetes and Endocrinology, Starship Children's Health, Auckland, New Zealand.,Liggins Institute, The University of Auckland, Auckland, New Zealand
| | - Esko Wiltshire
- Department of Paediatrics and Child Health, University of Otago, Wellington, Wellington, New Zealand.,Capital & Coast District Health Board, Wellington, New Zealand.,Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand
| | | | - Anita Lala
- Paediatrics, Bay of Plenty District Health Board, Tauranga, New Zealand
| | - Wayne Cutfield
- Paediatric Diabetes and Endocrinology, Starship Children's Health, Auckland, New Zealand.,Liggins Institute, The University of Auckland, Auckland, New Zealand
| | - Martin de Bock
- Department of Paediatrics, University of Otago, Christchurch, New Zealand.,Canterbury District Health Board, Christchurch, New Zealand
| | - Anna Serlachius
- Psychological Medicine, The University of Auckland, Auckland, New Zealand
| | - Craig Jefferies
- Paediatric Diabetes and Endocrinology, Starship Children's Health, Auckland, New Zealand.,Liggins Institute, The University of Auckland, Auckland, New Zealand
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Sünram-Lea SI, Gentile-Rapinett G, Macé K, Rytz A. Assessment of Glycemic Response to Model Breakfasts Varying in Glycemic Index (GI) in 5-7-Year-Old School Children. Nutrients 2021; 13:nu13124246. [PMID: 34959798 PMCID: PMC8707352 DOI: 10.3390/nu13124246] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2021] [Revised: 11/16/2021] [Accepted: 11/23/2021] [Indexed: 11/16/2022] Open
Abstract
Reduced Glycemic Index (GI) of breakfast has been linked to improved cognitive performance in both children and adult populations across the morning. However, few studies have profiled the post-prandial glycemic response (PPGR) in younger children. The aim of this study was to assess PPGR to breakfast interventions differing in GI in healthy children aged 5-7 years. Eleven subjects completed an open-label, randomized, cross-over trial, receiving three equicaloric test beverages (260 kcal) consisting of 125 mL semi-skimmed milk and 50 g sugar (either glucose, sucrose, or isomaltulose). On a fourth occasion, the sucrose beverage was delivered as intermittent supply. PPGR was measured over 180 min using Continuous Glucose Monitoring (CGM). The incremental area under the curve (3h-iAUC) was highest for the glucose beverage, followed by intermittent sucrose (-21%, p = 0.288), sucrose (-27%, p = 0.139), and isomaltulose (-48%, p = 0.018). The isomaltulose beverage induced the smallest Cmax (7.8 mmol/L vs. >9.2 mmol/L for others) and the longest duration with moderate glucose level, between baseline value and 7.8 mmol/L (150 vs. <115 min for others). These results confirm that substituting mid-high GI sugars (e.g., sucrose and glucose) with low GI sugars (e.g., isomaltulose) during breakfast are a viable strategy for sustained energy release and glycemic response during the morning even in younger children.
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Affiliation(s)
- Sandra I. Sünram-Lea
- Department of Psychology, Lancaster University, Lancaster LA1 4YF, UK
- Correspondence:
| | | | - Katherine Macé
- Nestlé Research Center, 1000 Lausanne, Switzerland; (G.G.-R.); (K.M.); (A.R.)
| | - Andreas Rytz
- Nestlé Research Center, 1000 Lausanne, Switzerland; (G.G.-R.); (K.M.); (A.R.)
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Alhodaib HI, Alsulihem S. Factors influencing the effectiveness of using flash glucose monitoring on glycemic control for type 1 diabetes in Saudi Arabia. World J Diabetes 2021; 12:1908-1916. [PMID: 34888015 PMCID: PMC8613657 DOI: 10.4239/wjd.v12.i11.1908] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/31/2021] [Revised: 07/29/2021] [Accepted: 09/17/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND In 2017, 35000 Saudi children and adolescents were living with a type 1 diabetes (T1D) diagnosis. Diabetic complications are minimized upon strengthened glycemic regulation. The annual cost of treating diabetic patients with complications was four-fold higher than for patients without complications. The use of flash glucose monitoring (FGM) enables better diabetes treatment and thereby improves glycemic control. Understanding the factors that affect effectiveness of FGM will help enhance the device’s use and management of hospital resources, resulting in improved outcomes.
AIM To investigate factors that affect effectiveness of the FGM system for glycated hemoglobin (HbA1c) levels/glycemic control among T1D patients.
METHODS A retrospective empirical analysis of T1D patient records from King Abdul-Aziz University Hospital and Prince Sultan Military Medical City was performed. T1D patients who began FGM between 2017 and 2019 were included.
RESULTS The data included 195 T1D patients (70 males and 125 females) with a mean age of 23.6 ± 8.1 years. Among them, 152 patients used multiple daily injection and 43 used an insulin pump. The difference in HbA1c level from baseline and after using FGM was -0.60 ± 2.10, with a maximum of 4.70 and a minimum of -6.30. There was a statistically significant negative correlation between the independent variables (age, duration of diabetes, level of engagement) and HbA1c. The group with the highest HbA1c mean (9.85) was 18-years-old, while the group with the lowest HbA1c mean (7.87) was 45-years-old. Patients with a low level of engagement (less than six scans per day) had the highest HbA1c mean (9.84), whereas those with a high level of engagement (more than eight scans per day) had the lowest HbA1c mean (8.33).
CONCLUSION With proper education, FGM can help people with uncontrolled T1D over the age of 18 years to control their glucose level.
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Affiliation(s)
- Hala Ibrahim Alhodaib
- Community Health Sciences Department, King Saud University, Riyadh 11564, Saudi Arabia
| | - Sama Alsulihem
- College of Medicine, King Saud University, Riyadh 11564, Saudi Arabia
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Al Hayek AA, Robert AA, Al Dawish MA. Effectiveness of the freestyle libre 2 flash glucose monitoring system on diabetes-self-management practices and glycemic parameters among patients with type 1 diabetes using insulin pump. Diabetes Metab Syndr 2021; 15:102265. [PMID: 34488057 DOI: 10.1016/j.dsx.2021.102265] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2021] [Revised: 08/25/2021] [Accepted: 08/27/2021] [Indexed: 12/19/2022]
Abstract
AIMS To determine the effectiveness of Freestyle Libre 2 (FSL2) on diabetes-self-management (DSM) practices and glycemic parameters among patients with type 1 diabetes (T1D) using insulin pump. METHODS This prospective study was performed among 47 patients with T1D (13-21yrs) who self-tested their glucose levels by the conventional finger-prick method using blood glucose meters (BGM). Data related to glycemic profile i.e., mean time in range (TIR), mean time above range (TAR) mean time below range (TBR), mean glucose level, hemoglobin A1c (HbA1c), total daily dose of insulin (TDDI), frequency of glucose monitoring and DSM responses were collected at baseline and 12 weeks. RESULTS The mean TIR was 59.8 ± 12.6%, TAR 32.7 ± 11.6%, TBR 7.5 ± 4.3%, mean glycemic variability, standard deviation 63.2 ± 12.5 mg/dL, and the coefficient of variation 41.3 ± 11.4% at 12 weeks. At baseline, the HbA1c level was 8.3%, and at 12 weeks, it dropped to 7.9% (p = 0.064). Baseline glucose monitoring frequency through BGM was 2.4/day; however, after the patients employed the FSL2, a higher degree of frequency of glucose monitoring was evident at 12 weeks as 8.2/day (p < 0.001). Significant improvements were observed in all the DSM subscales at 12 weeks. CONCLUSION Using FSL2 was found to raise the patients' DSM levels and improved metabolic control.
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Affiliation(s)
- Ayman A Al Hayek
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
| | - Asirvatham Alwin Robert
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
| | - Mohamed Abdulaziz Al Dawish
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
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Urakami T, Yoshida K, Kuwabara R, Mine Y, Aoki M, Suzuki J, Morioka I. Significance of "Time below Range" as a Glycemic Marker Derived from Continuous Glucose Monitoring in Japanese Children and Adolescents with Type 1 Diabetes. Horm Res Paediatr 2021; 93:251-257. [PMID: 32950993 DOI: 10.1159/000510454] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2020] [Accepted: 07/24/2020] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION We evaluated the frequencies of various glycemic markers derived from continuous glucose monitoring in Japanese children and adolescents with type 1 diabetes and assessed the significance of hypoglycemia duration. METHODS We enrolled 85 children and adolescents (36 boys and 49 girls) with type 1 diabetes who used FreeStyle® Libre in the present study. Frequencies of blood glucose levels as time within target range (TIR; 70-180 mg/dL), time below target range (TBR; <70 mg/dL), time below extreme hypoglycemia range (TBER; <54 mg/dL), and time above range (TAR; >180 mg/dL) were assessed during a 3-month study period. Furthermore, we evaluated the intraday frequencies of TBR and TBER. RESULTS The mean frequencies of TIR, TBR, and TAR were 52.7 ± 11.3%, 10.8 ± 5.4%, and 36.5 ± 10.8%, respectively, whereas the mean frequency of TBER was 1.1 ± 0.9% (0-3.0%); there was no clinical episode of severe hypoglycemia. The mean frequency of TBR was significantly greater in 0-6 h (16.9 ± 5.2%) than in 6-12 h (7.8 ± 2.9%) and 18-24 h (6.8 ± 4.8%; p < 0.01) time zones, respectively. DISCUSSION/CONCLUSION We found similar TIR and comparatively higher TBR frequencies, particularly during sleep, than those that were previously reported. Possible reasons for the higher frequency of TBR include differences in the quality of insulin treatment and diabetes care between the present study and the European studies. The utilization of advanced technologies, such as a predictive low-glucose suspend-function pump or closed-loop therapy, can reduce the frequency of TBR, with a consequent increase in TIR frequency and comprehensive improvement in glycemic control.
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Affiliation(s)
- Tatsuhiko Urakami
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan,
| | - Kei Yoshida
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Remi Kuwabara
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Yusuke Mine
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Masako Aoki
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Junichi Suzuki
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Ichiro Morioka
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
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Jessen W, Seibold A. Comparisons between accuracy of CGM systems in a pediatric setting can be outdated before they are published. Comment on Nagl et al. Pediatr Diabetes 2021; 22:832-833. [PMID: 33974732 DOI: 10.1111/pedi.13230] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2021] [Accepted: 05/05/2021] [Indexed: 11/29/2022] Open
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Daly A, Hovorka R. Technology in the management of type 2 diabetes: Present status and future prospects. Diabetes Obes Metab 2021; 23:1722-1732. [PMID: 33950566 PMCID: PMC7611289 DOI: 10.1111/dom.14418] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/05/2021] [Revised: 04/26/2021] [Accepted: 04/27/2021] [Indexed: 12/18/2022]
Abstract
The growing incidence of type 2 diabetes (T2D) is a significant health concern, representing 90% of diabetes cases worldwide. As the disease progresses, resultant insulin deficiency and hyperglycaemia necessitates insulin therapy in many cases. It has been recognized that a significant number of people who have a clinical requirement for insulin therapy, as well as their healthcare professionals, are reluctant to intensify treatment with insulin due to fear of hypoglycaemia, poor understanding of treatment regimens or lack of engagement, and are therefore at higher risk of developing complications from poor glycaemic control. Over the past decade, the rise of diabetes technologies, including dosing advisors, continuous glucose monitoring systems, insulin pumps and automated insulin delivery systems, has led to great improvements in the therapies available, particularly to those requiring insulin. Although the focus has largely been on delivering these therapies to the type 1 diabetes population, it is becoming increasingly recognized that people with T2D face similar challenges to achieve recommended glycaemic standards and also have the potential to benefit from these advances. In this review, we discuss diabetes technologies that are currently available for people with T2D and the evidence supporting their use, as well as future prospects. We conclude that there is a clinical need to extend the use of these technologies to the T2D population to curb the consequences of suboptimal disease management in this group.
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Affiliation(s)
- Aideen Daly
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
| | - Roman Hovorka
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
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Bahíllo-Curieses MP, Díaz-Soto G, Vidueira-Martínez AM, Torres-Ballester I, Gómez-Hoyos E, de Luis-Román D. Assessment of metabolic control and use of flash glucose monitoring systems in a cohort of pediatric, adolescents, and adults patients with Type 1 diabetes. Endocrine 2021; 73:47-51. [PMID: 33754313 DOI: 10.1007/s12020-021-02691-4] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/08/2020] [Accepted: 03/10/2021] [Indexed: 11/27/2022]
Abstract
PURPOSE Flash glucose monitoring (FGM) in patients with type 1 diabetes (DM1) provides glucometric data that allow assessing glycemic control beyond HbA1c. The objective of this study was to evaluate metabolic control and use of FGM in a cohort of the pediatric and adult population with DM1. MATERIAL AND METHODS A cross-sectional study of patients with DM1 and FGM. Data on the use of the system and metabolic control were evaluated, carrying out a comparative study between different age ranges, ≤12 years; 13-19 years, 20-25 years, and ≥26 years. RESULTS One hundred and ninety-five patients have included: 35.9% children and adolescents (≤19 years), 42.6% female, 26.2% in treatment with an insulin pump. Mean age was 28.5 ± 15.9 years, mean duration of diabetes 13.7 ± 11.0 years, and mean HbA1c 7.1 ± 0.9% (54 ± 6 mmol/l). Average daily FGM scans were 11.1 ± 6.7. Mean glucose was 162 ± 35 mg/dl, mean standard deviation (SD) 66.1 ± 20.4 mg/dl, mean coefficient of variation 41.4 ± 7.9%, mean time in range (TIR) 58.8 ± 17.0%, mean time above range 33.7 ± 17.6% and mean time below range 7.5 ± 5.8%. The pediatric group showed higher TIR, lower HbA1c, lower glycemic variability, lower mean glucose, and higher use of the device than the adult population. In the entire cohort, the device scans showed a negative quadratic correlation with HbA1c, mean glucose, SD, and age and a positive quadratic correlation with TIR. CONCLUSIONS Children under 12 years showed the best metabolic control and the most frequent use of the device. Metabolic control deteriorates with age. The greater number of device scans was in correlation with better metabolic control in all age groups.
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Affiliation(s)
- Mª Pilar Bahíllo-Curieses
- Pediatrics Department. Pediatric Endocrinology Unit, Hospital Clínico Universitario Valladolid, Avenida Ramón y Cajal number 3, 47005, Valladolid, Spain.
| | - Gonzalo Díaz-Soto
- Endocrinology and Nutrition Department, Hospital Clínico Universitario Valladolid, Avenida Ramón y Cajal 3, 47005, Valladolid, Spain
| | - Ana Mª Vidueira-Martínez
- Pediatrics Department. Pediatric Endocrinology Unit, Hospital Clínico Universitario Valladolid, Avenida Ramón y Cajal number 3, 47005, Valladolid, Spain
| | - Irune Torres-Ballester
- Pediatrics Department. Pediatric Endocrinology Unit, Hospital Clínico Universitario Valladolid, Avenida Ramón y Cajal number 3, 47005, Valladolid, Spain
| | - Emilia Gómez-Hoyos
- Endocrinology and Nutrition Department, Hospital Clínico Universitario Valladolid, Avenida Ramón y Cajal 3, 47005, Valladolid, Spain
| | - Daniel de Luis-Román
- Endocrinology and Nutrition Department, Hospital Clínico Universitario Valladolid, Avenida Ramón y Cajal 3, 47005, Valladolid, Spain
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Wilson S, Bohn MK, Adeli K. POCT: An Inherently Ideal Tool in Pediatric Laboratory Medicine. EJIFCC 2021; 32:145-157. [PMID: 34421483 PMCID: PMC8343051] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Point of care testing (POCT) is important in the provision of timely laboratory test results and continues to gain specific appreciation in the setting of pediatric healthcare. POCT platforms offer several advantages compared to central laboratory testing, including improved clinical outcomes, reduced time to diagnosis, length of stay, and blood volume requirements, as well as increased accessibility. These advantages are most pronounced in acute care settings such as pediatric emergency departments, intensive care units, and in remote settings, wherein rapid patient assessment and prognostication is essential to patient outcomes. The current review provides an overview and critical discussion of the evidence supporting clinical implementation of POCT systems in pediatric clinical decision-making, including but not limited to the diagnosis of viral and bacterial infection, identification of critical glucose and electrolyte dysregulation, and prognostication of post-operative inpatients. Important considerations for test result reporting and interpretation are also discussed, including analytical concordance between POCT systems and central laboratory analyzers as well as availability of pediatric reference intervals for key analytes on POCT systems. Notably, a paucity of evidence-based pediatric reference intervals for test interpretation for critical care parameters on POCT platforms is highlighted, warranting further study and unique consideration prior to clinical implementation.
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Affiliation(s)
- Siobhan Wilson
- Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada
- Department of Laboratory Medicine & Pathobiology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Mary Kathryn Bohn
- Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada
- Department of Laboratory Medicine & Pathobiology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Khosrow Adeli
- Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada
- Department of Laboratory Medicine & Pathobiology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
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Bosoni P, Calcaterra V, Tibollo V, Malovini A, Zuccotti G, Mameli C, Sacchi L, Bellazzi R, Larizza C. Exploring the inter-subject variability in the relationship between glucose monitoring metrics and glycated hemoglobin for pediatric patients with type 1 diabetes. J Pediatr Endocrinol Metab 2021; 34:619-625. [PMID: 33823102 DOI: 10.1515/jpem-2020-0725] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2020] [Accepted: 03/01/2021] [Indexed: 11/15/2022]
Abstract
OBJECTIVES Despite the widespread diffusion of continuous glucose monitoring (CGM) systems, which includes both real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), an effective application of CGM technology in clinical practice is still limited. The study aimed to investigate the relationship between isCGM-derived glycemic metrics and glycated hemoglobin (HbA1c), identifying overall CGM targets and exploring the inter-subject variability. METHODS A group of 27 children and adolescents with type 1 diabetes under multiple daily injection insulin-therapy was enrolled. All participants used the isCGM Abbott's FreeStyle Libre system on average for eight months, and clinical data were collected from the Advanced Intelligent Distant-Glucose Monitoring platform. Starting from each HbA1c exam date, windows of past 30, 60, and 90 days were considered to compute several CGM metrics. The relationships between HbA1c and each metric were explored through linear mixed models, adopting an HbA1c target of 7%. RESULTS Time in Range and Time in Target Range show a negative relationship with HbA1c (R2>0.88) whereas Time Above Range and Time Severely Above Range show a positive relationship (R2>0.75). Focusing on Time in Range in 30-day windows, random effect represented by the patient's specific intercept reveals a high variability compared to the overall population intercept. CONCLUSIONS This study confirms the relationship between several CGM metrics and HbA1c; it also highlights the importance of an individualized interpretation of the CGM data.
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Affiliation(s)
- Pietro Bosoni
- Department of Electrical, Computer and Biomedical Engineering, Università degli Studi di Pavia, Pavia, Italy
| | - Valeria Calcaterra
- Pediatric Department, "Vittore Buzzi" Children's Hospital, Milano, Italy
- Pediatric and Adolescent Unit, Department of Internal Medicine, Università degli Studi di Pavia, Pavia, Italy
| | - Valentina Tibollo
- Istituti Clinici Scientifici Maugeri SpA-Società Benefit IRCCS, Pavia, Italy
| | - Alberto Malovini
- Istituti Clinici Scientifici Maugeri SpA-Società Benefit IRCCS, Pavia, Italy
| | - Gianvincenzo Zuccotti
- Pediatric Department, "Vittore Buzzi" Children's Hospital, Milano, Italy
- Department of Biomedical and Clinical Science "L. Sacco", Università degli Studi di Milano, Milano, Italy
| | - Chiara Mameli
- Pediatric Department, "Vittore Buzzi" Children's Hospital, Milano, Italy
- Department of Biomedical and Clinical Science "L. Sacco", Università degli Studi di Milano, Milano, Italy
| | - Lucia Sacchi
- Department of Electrical, Computer and Biomedical Engineering, Università degli Studi di Pavia, Pavia, Italy
| | - Riccardo Bellazzi
- Department of Electrical, Computer and Biomedical Engineering, Università degli Studi di Pavia, Pavia, Italy
- Istituti Clinici Scientifici Maugeri SpA-Società Benefit IRCCS, Pavia, Italy
| | - Cristiana Larizza
- Department of Electrical, Computer and Biomedical Engineering, Università degli Studi di Pavia, Pavia, Italy
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Pemberton JS, Kershaw M, Dias R, Idkowiak J, Mohamed Z, Saraff V, Barrett TG, Krone R, Uday S. DYNAMIC: Dynamic glucose management strategies delivered through a structured education program improves time in range in a socioeconomically deprived cohort of children and young people with type 1 diabetes with a history of hypoglycemia. Pediatr Diabetes 2021; 22:249-260. [PMID: 33205572 DOI: 10.1111/pedi.13155] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2020] [Revised: 10/28/2020] [Accepted: 11/11/2020] [Indexed: 12/21/2022] Open
Abstract
OBJECTIVES Create and evaluate the effectiveness of a structured education program in children and young people (CYP) with type 1 diabetes using continuous glucose monitoring (CGM). DESIGN AND METHODS Step 1: CGM devices were evaluated for predetermined criteria using a composite score. Step 2: The education program was developed following review of international structured education guidance, dynamic glucose management (DynamicGM) literature, award-winning diabetes educators' websites, and CGM user feedback. Step 3: Program effectiveness was assessed at six months by change in time below range (TBR) (<3.9mmol/L), time in range (TIR) (3.9-10.0mmol/L), time above range level 2 (TAR2) (>13.9mmol/L), severe hypoglycemia and HbA1c using a paired T-test. A DynamicGM score was developed to assess proactive glucose management. Factors predicting TBR and TIR were assessed using regression analysis. RESULTS Dexcom G6 was chosen for integrated CGM (iCGM) status and highest composite score (29/30). Progressive DynamicGM strategies were taught through five sessions delivered over two months. Fifty CYP (23 male) with a mean (±SD) age and diabetes duration of 10.2 (±4.8) and 5.2 (±3.7) years respectively, who completed the education program were prospectively evaluated. Evaluation at six months showed a significant reduction in TBR (10.4% to 2.1%, p<.001), TAR2 (14.1% to 7.3%, p<.001), HbA1c [7.4 to 7.1% (57.7 to 53.8 mmol/mol), p<.001] and severe hypoglycemic episodes (10 to 1, p<.05); TIR increased (47.4% to 57.0%, p<.001). Number of Dexcom followers (p<.05) predicted reduction in TBR and DynamicGM score (p<.001) predicted increased TIR. CONCLUSION Teaching DynamicGM strategies successfully improves TIR and reduces hypoglycemia.
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Affiliation(s)
- John S Pemberton
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK
| | - Melanie Kershaw
- Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
| | - Renuka Dias
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.,Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
| | - Jan Idkowiak
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.,Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
| | - Zainab Mohamed
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK
| | - Vrinda Saraff
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK
| | - Timothy G Barrett
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.,Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
| | - Ruth Krone
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK
| | - Suma Uday
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.,Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
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Biester T, Grimsmann JM, Heidtmann B, Rami-Merhar B, Ermer U, Wolf J, Freff M, Karges B, Agena D, Bramlage P, Danne T, Holl RW. Intermittently Scanned Glucose Values for Continuous Monitoring: Cross-Sectional Analysis of Glycemic Control and Hypoglycemia in 1809 Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther 2021; 23:160-167. [PMID: 33084351 DOI: 10.1089/dia.2020.0373] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Background and Objective: Intermittent scanning continuous glucose monitoring (iscCGM) is increasingly used for glycemic monitoring in diabetes care. In this cross-sectional real-world analysis, iscCGM data were compared to traditional parameters of glycemic control in young people with type 1 diabetes. Methods: Using the DPV registry, most recent data from children and adolescents aged <18 years with uploaded iscCGM sensor profiles with at least 14 days of data and a > 50% completeness were evaluated using recommended parameters of sensor metrics. Analysis was performed stratified by age group, glycemic control, and type of therapy; data were taken from DPV data pool in February 2020. Results: Glucose sensor profiles and clinical data from 1809 individuals (mean age 13.4 years, 53% male, and mean diabetes duration 5.02 years) were evaluated in this study. More than 50% of this population (n = 965) reached the current German treatment target of hemoglobin A1c (HbA1c) <7.5%. In this target, the mean scanning frequency was higher than in groups with HbA1c >7.5 or >8.0% (12.0 vs. 10.2 vs 7.6 times per day). The group of preschool children had the highest frequency of scanning (16.6 vs. 13.3 times per day in school kids and 7.9 in adolescents), the lowest HbA1c level, and the lowest risk for hypoglycemia (low blood glucose index 0.8 vs. 1.0 vs 1.2). Conclusion: Real-world data will help to determine the value of iscCGM to improve clinical and patient-related outcomes in pediatric diabetology. Not only the use of a device but also the intensity of use seems to have a high and direct impact on glycemic control.
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Affiliation(s)
- Torben Biester
- Kinder-und Jugendkrankenhaus AUF DER BULT, Hannover, Germany
| | - Julia M Grimsmann
- Institut für Epidemiologie und Medizinische Biometrie, ZIBMT, Universität Ulm, Ulm, Germany
- Deutsches Zentrum für Diabetesforschung (DZD), München-Neuherberg, Germany
| | | | - Birgit Rami-Merhar
- Medical University of Vienna, Austria, Department od Pediatric and Adolescent Medicine, Vienna, Austria
| | - Uwe Ermer
- Kliniken St. Elisabeth, Klinik für Kinder-und Jugendmedizin, Neuburg, Germany
| | - Johannes Wolf
- Klinik für Kinder-und Jugendmedizin St. Louise, St. Vincenz-Krankenhaus, Paderborn, Germany
| | - Markus Freff
- Darmstädter Kinderkliniken Prinzessin Margaret, Darmstadt, Germany
| | - Beate Karges
- Bethlehem Gesundheitszentrum, Klinik für Kinder-und Jugendmedizin, Stolberg, Germany
- Division of Endocrinology and Diabetes, RWTH Aachen University, Aachen, Germany
| | - Dirk Agena
- Kinderärztliche Gemeinschaftspraxis Franziska Fritz und Dirk Agena, Hildesheim, Germany
| | - Peter Bramlage
- Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
| | - Thomas Danne
- Kinder-und Jugendkrankenhaus AUF DER BULT, Hannover, Germany
| | - Reinhard W Holl
- Institut für Epidemiologie und Medizinische Biometrie, ZIBMT, Universität Ulm, Ulm, Germany
- Deutsches Zentrum für Diabetesforschung (DZD), München-Neuherberg, Germany
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Al Hayek A, Robert AA, Al Dawish M. Impact of the FreeStyle Libre flash glucose monitoring system on diabetes- self-management practices and glycemic control among patients with type 2 diabetes in Saudi Arabia: A prospective study. Diabetes Metab Syndr 2021; 15:557-563. [PMID: 33689937 DOI: 10.1016/j.dsx.2021.02.027] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2020] [Revised: 02/16/2021] [Accepted: 02/20/2021] [Indexed: 01/08/2023]
Abstract
BACKGROUND AND AIMS To examine the efficacy of FreeStyle Libre Flash Glucose Monitoring System (FGMS) on Diabetes Self-Management Practices (DSMP) and glycemic control among patients with type 2 diabetes (T2D). METHODS This prospective study was conducted among 105 patients with T2D (aged 30-70 years), who self-tested their glucose levels by conventional finger-prick method using blood glucose meters (BGM). At baseline visit, FGMS sensors were fixed by a diabetes educator to all patients. At the baseline and at 12 weeks of the study, an interviewer collected the responses of Diabetes Self-Management (DSM) from all the study population using a questionnaire. RESULTS At 12 weeks, significant improvements in the DSM subscales were observed, which includes glucose management (P = 0.042), dietary control (P = 0.048), physical activity (P = 0.043), health care use (P = 0.001) and self-care (P = 0.001), compared to the values at baseline. At baseline, when the HbA1c level was 8.2%, at 12 weeks, it dropped to 7.9%. Also, at baseline, when the hypoglycemia frequency was 3.1, it declined to 1.2 episodes/month at 12 weeks. While comparing the blood glucose monitoring through BGM at the baseline (1.92/day), a higher degree of frequency of blood glucose monitoring was evident at 12 weeks (6.84/day), after the patients employed the FreeStyle Libre. CONCLUSION After 12 weeks of using the FreeStyle Libre, the frequency of hypoglycemic episodes and the HbA1c levels were dropped, while the practice of DSM and frequency of blood glucose monitoring were improved.
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Affiliation(s)
- Ayman Al Hayek
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
| | - Asirvatham Alwin Robert
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
| | - Mohamed Al Dawish
- Department of Endocrinology and Diabetes, Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
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Suzuki J, Urakami T, Yoshida K, Kuwabara R, Mine Y, Aoki M, Morioka I. Association between scanning frequency of flash glucose monitoring and continuous glucose monitoring-derived glycemic makers in children and adolescents with type 1 diabetes. Pediatr Int 2021; 63:154-159. [PMID: 32744360 DOI: 10.1111/ped.14412] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/08/2020] [Revised: 07/08/2020] [Accepted: 07/22/2020] [Indexed: 12/30/2022]
Abstract
BACKGROUND We assessed the association between scanning frequency of flash glucose monitoring (FGM) and continuous glucose monitoring (CGM)-derived glycemic markers in children and adolescents with type 1 diabetes. METHODS Subjects consisted of 85 children and adolescents with type 1 diabetes using FGM. We assessed the association between scanning frequencies of FGM- and CGM-derived metrics: Time in range (TIR) (70-180 mg/dL), time below range (TBR) (<70 mg/dL), time above range (>180 mg/dL), and other glycemic markers - laboratory-measured HbA1c and CGM-estimated glucose and HbA1c (eA1c) levels in the subjects. RESULTS The mean number of scans was 11.5 ± 3.5 (5-20) times per day, and scanning was most frequently conducted during a period of 18-24 h. Scanning frequency showed significant positive correlation with TIR (r = 0.719, P < 0.0001) and inverse correlation with time above range (r = -0.743, P < 0.0001), but did not correlate with TBR. There were also significant inverse correlations between scanning frequency and glucose, HbA1c, and eA1c levels (r = -0.765, -0.815, and -0.793, respectively, P < 0.0001). CONCLUSIONS Frequent glucose testing with FGM decreased hyperglycemia with increased TIR, but did not reduce TBR. Coping with a rapid fall of glucose and unexpected hypoglycemia with more advanced technology might contribute to a reduction in TBR.
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Affiliation(s)
- Junichi Suzuki
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
| | - Tatsuhiko Urakami
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
| | - Kei Yoshida
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
| | - Remi Kuwabara
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
| | - Yusuke Mine
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
| | - Masako Aoki
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
| | - Ichiro Morioka
- Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan
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Marsters BL, Boucher SE, Galland BC, Wiltshire EJ, de Bock MI, Tomlinson PA, Rayns J, MacKenzie KE, Chan H, Wheeler BJ. Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus. Pediatr Diabetes 2020; 21:1516-1524. [PMID: 32935921 DOI: 10.1111/pedi.13121] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2020] [Revised: 07/13/2020] [Accepted: 08/28/2020] [Indexed: 12/01/2022] Open
Abstract
BACKGROUND The literature regarding flash glucose monitoring (FGM)-associated cutaneous adverse events (AE) is limited. OBJECTIVES This study among youth participating in a 6 month randomized controlled trial aimed to compare cutaneous AE between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss. METHODS Patients aged 13 to 20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self-reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type, and severity of cutaneous AEs, and evaluate premature sensor loss. RESULTS Sixty-four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group); however, the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = .004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate, and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6 months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE. CONCLUSIONS Cutaneous FGM-associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM.
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Affiliation(s)
- Brooke L Marsters
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Sara E Boucher
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Barbara C Galland
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Esko J Wiltshire
- Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand
| | - Martin I de Bock
- Department of Paediatrics, University of Otago, Christchurch, New Zealand.,Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand
| | - Paul A Tomlinson
- Paediatric Department, Southern District Health Board, Invercargill, New Zealand
| | - Jenny Rayns
- Endocrinology Department, Southern District Health Board, Dunedin, New Zealand
| | - Karen E MacKenzie
- Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand
| | - Huan Chan
- Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand
| | - Benjamin J Wheeler
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
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Marsters BL, Boucher SE, Galland BC, de Lange M, Wiltshire EJ, de Bock MI, Elbalshy MM, Tomlinson PA, Rayns J, MacKenzie KE, Chan H, Wheeler BJ. The 'flash' adhesive study: a randomized crossover trial using an additional adhesive patch to prolong freestyle libre sensor life among youth with type 1 diabetes mellitus. Acta Diabetol 2020; 57:1307-1314. [PMID: 32519221 DOI: 10.1007/s00592-020-01556-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Accepted: 05/28/2020] [Indexed: 11/28/2022]
Abstract
AIMS Although strategies to prevent premature sensor loss for flash glucose monitoring (FGM) systems may have substantial benefit, limited data are available. This study among youth with high-risk type 1 diabetes evaluated whether an additional adhesive patch over FGM sensors would reduce premature sensor loss frequency and not cause additional cutaneous adverse events (AEs). METHODS This is a six-month, open-label, randomized crossover trial. Participants were recruited at completion of prior 'Managing Diabetes in a Flash' randomized controlled trial and allocated to three months of Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention), before crossing over to the opposite study arm. Participants self-reported patch use or non-use, premature sensor loss and cutaneous AEs fortnightly via an electronic questionnaire. RESULTS Thirty-four participants were enrolled: mean age (± SD) 17.0 (± 2.2) years; mean HbA1c (± SD) 89 (± 16) mmol/mol (10.3% ± 1.4%). The response rate of questionnaires was 77% (314/408). Premature sensor loss was reported in 18% (58/314) of questionnaires: 20% (32/162) from intervention and 17% (26/152) from control (p = 0.56). Thirty-eight percent (118/314) of questionnaires were non-compliant to protocol allocation. However, per-protocol analysis showed similar findings. No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27). CONCLUSIONS The adhesive patch investigated in this study does not appear to prevent premature FGM sensor loss. However, the low risk of AEs and low cost of an adhesive patch suggest an individualized approach to their use may still be warranted. Further research is needed to explore alternative strategies to prevent sensor loss.
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Affiliation(s)
- Brooke L Marsters
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Sara E Boucher
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Barbara C Galland
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Michel de Lange
- Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand
| | - Esko J Wiltshire
- Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand
| | - Martin I de Bock
- Department of Paediatrics, University of Otago, Christchurch, New Zealand
- Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand
| | - Mona M Elbalshy
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
| | - Paul A Tomlinson
- Paediatric Department, Southern District Health Board, Invercargill, New Zealand
| | - Jenny Rayns
- Endocrinology Department, Southern District Health Board, Dunedin, New Zealand
| | - Karen E MacKenzie
- Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand
| | - Huan Chan
- Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand
| | - Benjamin J Wheeler
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
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Del Baldo F, Canton C, Testa S, Swales H, Drudi I, Golinelli S, Fracassi F. Comparison between a flash glucose monitoring system and a portable blood glucose meter for monitoring dogs with diabetes mellitus. J Vet Intern Med 2020; 34:2296-2305. [PMID: 33124730 PMCID: PMC7694810 DOI: 10.1111/jvim.15930] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2020] [Revised: 09/22/2020] [Accepted: 09/25/2020] [Indexed: 12/15/2022] Open
Abstract
Background Flash glucose monitoring system (FGMS; FreeStyle Libre) was recently validated for use in diabetic dogs (DD). It is not known if this system is clinically useful in monitoring DD. Objective To compare the clinical utility of FGMS against blood glucose curves (BGCs) obtained with a portable blood glucose meter (PBGM) in monitoring DD. Animals Twenty dogs with diabetes mellitus. Methods Prospective study. Dogs with diabetes mellitus on insulin treatment for at least 1 month were included. Comparisons of insulin dose recommendations based on the in‐hospital GCs acquired using FGMS and a PBGM, consecutive‐day interstitial GCs (IGCs) acquired at home using the FGMS, and consecutive‐day, home vs hospital IGCs acquired using the FGMS were made using concordance analysis. Results There was good concordance between insulin dose recommendations based on FGMS and PBGM generated GCs and IGCs obtained in the 2 different environments on 2 consecutive days, but almost absent concordance between IGCs obtained on 2 consecutive days at home. Glucose nadirs were detected in 34/43 (79%) of Ambulatory Glucose Profile (AGP) reports of the FGMS. In comparison, concordant glucose nadirs were identified in 14/34 (41%) BGCs using PBGM. The individual FGMS scans and PBGM identified 60% and 9% of low IG/hypoglycemic episodes, respectively. Conclusions and Clinical Importance Insulin dose adjustments based on BGCs can be suboptimal. The FGMS allows a more accurate identification of the glucose nadirs and hypoglycemic episodes compared to the use of a PBGM and assessment of day‐to‐day variations in glycemic control.
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Affiliation(s)
- Francesca Del Baldo
- Department of Veterinary Medical Science, University of Bologna, Ozzano dell'Emilia, Bologna, Italy
| | - Claudia Canton
- Department of Veterinary Medical Science, University of Bologna, Ozzano dell'Emilia, Bologna, Italy
| | - Silvia Testa
- Department of Veterinary Medical Science, University of Bologna, Ozzano dell'Emilia, Bologna, Italy
| | - Harry Swales
- Small Animal Teaching Hospital, Leahurst Campus, University of Liverpool, Wirral, United Kingdom
| | - Ignazio Drudi
- Department of Statistical Sciences, University of Bologna, Bologna, Italy
| | - Stefania Golinelli
- Department of Veterinary Medical Science, University of Bologna, Ozzano dell'Emilia, Bologna, Italy
| | - Federico Fracassi
- Department of Veterinary Medical Science, University of Bologna, Ozzano dell'Emilia, Bologna, Italy
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Urakami T, Yoshida K, Kuwabara R, Mine Y, Aoki M, Suzuki J, Morioka I. Individualization of recommendations from the international consensus on continuous glucose monitoring-derived metrics in Japanese children and adolescents with type 1 diabetes. Endocr J 2020; 67:1055-1062. [PMID: 32565500 DOI: 10.1507/endocrj.ej20-0193] [Citation(s) in RCA: 11] [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: 11/23/2022] Open
Abstract
We assessed the significance of recommendations from the international consensus on continuous glucose monitoring (CGM)-derived metrics in Japanese children and adolescents with type 1 diabetes. Eighty-five patients (age, 13.5 ± 4.7 years) who wore the FreeStyle® Libre for a 28-day period were enrolled in this study. Seventy-three patients were treated with multiple daily injections of insulin and 12 with insulin pump therapy without using a sensor-augmented pump or a predictive low-glucose suspend-function pump. We evaluated the relationship between CGM-derived metrics: time in range (TIR: 70-180 mg/dL), time below range (TBR: <70 mg/dL), and time above range (TAR: >180 mg/dL), and laboratory-measured HbA1c and estimated HbA1c (eA1c) levels calculated from the mean glucose values. The TIR was 50.7 ± 12.2% (23-75%), TBR was 11.8 ± 5.8% (2-27%), and TAR was 37.5 ± 13.5% (9-69%). The TIR was highly correlated with HbA1c level, eA1c level, and TAR, but not with TBR. An HbA1c level of 7.0% corresponded to a TIR of 55.1% (95% CI: 53.7-56.5%), whereas a TIR of 70% corresponded to an HbA1c level of 6.1% (95% CI: 5.9-6.3%). The results of eA1c levels were similar to those observed for HbA1c levels. From these findings, we conclude that low rates of a recommended TIR of 70% may be due to less use of advanced technology and insufficient comprehensive diabetes care. Ethnic characteristics including lifestyle and eating customs may have contributed to the result. CGM-derived targets must be individualized based on ethnic characteristics, insulin treatment and diabetes care, and needs of individuals with diabetes.
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Affiliation(s)
- Tatsuhiko Urakami
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Kei Yoshida
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Remi Kuwabara
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Yusuke Mine
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Masako Aoki
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Junichi Suzuki
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
| | - Ichiro Morioka
- Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan
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Boucher SE, Gray AR, Wiltshire EJ, de Bock MI, Galland BC, Tomlinson PA, Rayns JA, MacKenzie KE, Chan H, Rose S, Wheeler BJ. Effect of 6 Months of Flash Glucose Monitoring in Youth With Type 1 Diabetes and High-Risk Glycemic Control: A Randomized Controlled Trial. Diabetes Care 2020; 43:2388-2395. [PMID: 32788281 DOI: 10.2337/dc20-0613] [Citation(s) in RCA: 37] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2020] [Accepted: 07/15/2020] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control. RESEARCH DESIGN AND METHODS This multicenter 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA1c) ≥9% (≥75 mmol/mol). Participants were allocated to 6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) (n = 33) or control (SMBG; n = 31) using minimization. The primary outcome was the difference in change in HbA1c from baseline to 6 months. RESULTS There was no evidence of a difference between groups for changes in HbA1c at 6 months (adjusted mean 0.2% greater improvement for isCGM [95% CI -0.9 to 0.5] [-2.1 mmol/mol (95% CI -9.6 to 5.4)]; P = 0.576). However, glucose-monitoring frequency was 2.83 (95% CI 1.72-4.65; P < 0.001) times higher in the isCGM group compared with that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months (P = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all P > 0.1). CONCLUSIONS For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months.
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Affiliation(s)
- Sara E Boucher
- Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
| | - Andrew R Gray
- Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand
| | - Esko J Wiltshire
- Department of Paediatrics and Child Health, University of Otago, Wellington, Wellington, New Zealand.,Capital & Coast District Health Board, Wellington, New Zealand
| | - Martin I de Bock
- Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand
| | - Barbara C Galland
- Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
| | - Paul A Tomlinson
- Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
| | - Jenny A Rayns
- Endocrinology Department, Southern District Health Board, Dunedin, New Zealand
| | - Karen E MacKenzie
- Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand
| | - Huan Chan
- Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand
| | - Shelley Rose
- Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
| | - Benjamin J Wheeler
- Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand .,Paediatric Department, Southern District Health Board, Dunedin, New Zealand
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