AIM: We aim to compare commercial automated insulin delivery (C-AID) systems with open-source do-it-yourself (DIY)-AID systems for glucose management among adults with type 1 diabetes (T1D) in real-life conditions. METHODS: A prospective observational, non-inferiority, parallel-cohort study involving 77 adults with T1D, having used an AID for ≥3 months and living in Canada (25 DIY-AID and 52 C-AID users): 59.7% females, mean age 44.0 ± 14.7 years old with mean diabetes duration of 26.9 ± 14.5 years and HbA1c of 6.7 ± 0.7%. A total of 30 days’ data from an additional blinded CGM (Dexcom G6) was used to assess effectiveness [Primary outcome: 24h time in range% (TIR%) for 30 days]. RESULTS: DIY-AIDs were non-inferior to C-AIDs regarding the TIR% [78.3±11.0% vs. 71.2±10.9%, mean difference 7.2% [95% CI 1.9% to 12.5%], P<0.001 for non-inferiority (non-inferiority margin 5%)], even after adjusting for various confounding factors (age, sex, auto-mode%, duration of AID use, annual household income, and educational level). The percentage of time in hypoglycemia (<70 mg/dL) was higher with DIY-AID (3.9±3.1%) than with C-AID (1.8±1.3%) but still below recommended threshold (Table). Differences between both systems are more pronounced during daytime. CONCLUSION: DIY-AIDs are non-inferior to C-AIDs for TIR% among adults with T1D in real-world settings. Disclosure Z.Wu: Other Relationship; Eli Lilly and Company. R.Rabasa-lhoret: Consultant; Dexcom, Inc., Abbott, Janssen Pharmaceuticals, Inc., Novo Nordisk Canada Inc., Sanofi, Lilly, Tandem Diabetes Care, Inc., Insulet Corporation. M.Lebbar: None. A.Bonhoure: Consultant; Dexcom, Inc. M.Raffray: None. M.Devaux: None. C.Grou: None. V.Messier: None. V.Boudreau: None. A.Brazeau: Other Relationship; Dexcom, Inc., Diabète québec, Ordre des diététistes nutritionnistes du Québec, Research Support; Canadian Institutes of Health Research, Fonds de recherche du Québec en Santé. Funding Canadian Institutes of Health Research (148464)
Background: Only three studies have directly compared the efficacy of dual-hormone (DH) automated insulin delivery (AID) systems and single-hormone (SH) AID on overnight glucose management in pediatric people living with type 1 diabetes (PPWT1D) . Their conclusions differ. Pooling data could lead to stronger conclusions. Methods: Pooled data from 3 open-label, randomized, controlled, crossover studies on comparing DH-AID and SH-AID among PPWT1D (8-17 y/o) . The primary outcome was time in range% (TIR%) overnight (00:00-06:00) based on continuous glucose monitoring. Paired t-test was applied to compare the two groups. Results: Records from 50 PPWT1D [median (Q1-Q3) age: 14.0 years (11.8, 16.0) , mean ± SD HbA1c: 8.2 ± 0.8%] provided 246 nights of data (Table) . TIR% [ (median (IQR) ] for SH-AID and DH-AID was 91.3% (58.3, 100.0) and 94.4% (76.4, 100.0) , respectively (P=0.024) . DH-AID was superior to SH-AID in reducing time in hypo- (<3.9 mmol/L) and hyperglycemia (>13.9 mmol/L) but not glycemic variability. Conclusion: DH-AID has the potential to provide better overnight glucose management than SH-AID in PPWT1D. Disclosure Z.Wu: Other Relationship; Eli Lilly and Company. V.Messier: None. M.Lebbar: None. R.Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc. Funding Diabetes Canada grant (OG-2-12-3868-RR,OG-2-13-42P, OG-3-14-4500-RR) and Fondation JA De Sève
Introduction: Hypoglycemia is a common side effect of type 1 diabetes (T1D) therapy with consequences ranging from physical and cognitive impairment to reduced quality of life. Studies evaluating consequences of level 2 (L2H, glucose level<3.0mmol/L without needing assistance from another person to recover) and level 3 (L3H, needing assistance from another person) hypoglycemia between the genders are sparse. Aim: To highlight the differences in reported consequences related to both L2H and L3H between genders. Methods: Self-reported data from an online Canadian registry of adults with T1D were analyzed using logistic regression models adjusted for age, diabetes technology use, hypoglycemia history in the past month, Hypoglycemia Fear Survey II (HFS II) , and Hypoglycemia Confidence Scale (HCS) scores. Results: Among 877 adults (65% women, mean age 43 ± 15 years, mean duration of T1D 25 ± 15 years, 34% reported a HbA1c ≤ 7.0%, 81% used continuous glucose monitoring, and 43% used an insulin pump) , 15% experienced L3H in the past year and 81% experienced L2H in the past month. Women reported more L2H (84% vs. 75%, p=0.004) and worse HFS-II and HCS scores than men (median 33 [IQR 23, 47] vs. 28 [18, 38], p=0.002 and 3.2 [2.9, 3.6] vs. 3.4 [3.0, 3.8], p<0.001, respectively) . The adjusted regression models showed that women were more likely than men to report experiencing persistent fatigue after L2H (OR 1.76, 95%CI [1.19, 2.61]) and increased anxiety, persistent fatigue, or an additional encounter with a healthcare professional after a L3H episode (1.71 [1.04, 2.82]; 1.75 [1.02, 3.00]; 2.59 [1.17, 5.74], respectively) . Conclusion: Women report significantly more L2H and L3H consequences compared to men, in addition to reporting higher fear and lower confidence. Social constructs on stress management may explain the observed gender differences, and suggest taking a gender-based differential approach when addressing hypoglycemia. Disclosure M. K. Talbo: None. M. Lebbar: None. V. Messier: None. Z. Wu: Other Relationship; Eli Lilly and Company. A. Brazeau: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. R. Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker’s Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc. Funding Canadian Institutes of Health Research (JT1-157204) and Juvenile Diabetes Research Foundation (4-SRA-2018-651-Q-R)
Introduction: Despite the rapid advances of diabetes technologies, postprandial glucose management remains a challenge for people living with type 1 diabetes (pwT1D). We aim to assess the efficacy of single-hormone (SH) compared to dual-hormone (DH) automated insulin delivery (AID) systems in postprandial glucose management. Methods: Post-hoc analysis of a randomized controlled crossover inpatient trial including three standardized meals (taken at 8am, 12 pm, and 5pm) during a 24-hour period, comparing SH-AID and DH-AID among pwT1D. Data from meals of each participant was pooled. Primary outcome was time in range % (TIR%, 70 to 180 mg/dL), calculated by continuous glucose monitoring during the 4-hour postprandial period. Paired t-test was used to compare the two groups. Results: Eighteen adult participants were included (mean age [SD] 43 [14] years, mean duration of T1D 20 [11] years, mean HbA1c 7.6% [1.0], mean daily insulin intake 26.70 [11.04] units). Postprandial TIR% was similar between SH and DH-AID (66.4% vs 70.2%, p=0.443). Less time in postprandial hypoglycemia (<70 mg/dL) was observed in the DH-AID group compared to SH-AID (5.4% vs 11.9%, p=0.019). No difference was observed in postprandial time spent in hyperglycemia (>180 mg/dL), glycemic variability indices or insulin intake between the two groups. Conclusion: Compared with SH-AID, DH-AID reduces postprandial hypoglycemia, while other postprandial glucose metrics remain similar among adult pwT1D. Disclosure M. Lebbar: None. J. Molveau: None. V. Boudreau: None. R. Rabasa-lhoret: Consultant; Dexcom, Inc., Abbott, Janssen Pharmaceuticals, Inc., Novo Nordisk Canada Inc., Sanofi, Lilly, Tandem Diabetes Care, Inc., Insulet Corporation. Z. Wu: Other Relationship; Eli Lilly and Company.
For people living with type 1 diabetes (PWT1D) post-prandial exercise remains a challenge for the maintenance of glycemic control even with automated insulin delivery systems (AID) . During the postprandial phase, elevated insulin levels, rapid changes in glucose levels with increased CGM lag time make it difficult for AID algorithms to mitigate the risk of hypoglycemia by solely relying on basal rate modulation. The main objective of this study was to assess the safety and efficacy of AID using a combination strategy of pre-meal exercise announcement and meal bolus reduction during exercise bouts performed 1- and 2-hours post-meal. Thirteen adults PWT1D chronically treated with AID (6 females; A1c = 7.9 ± 0.6%; Age= 53,5 ± 15,5 years; T1D duration= 29.0 ± 16.0 years) were included. Participants performed in a randomized crossover fashion 2 60-min exercise sessions (60% of VO2peak) , 1 (60Ex) and 2-h (120Ex) post-meal. A standardized meal was given at 8AM with a 33% insulin bolus reduction and exercise was announced to the AID algorithm (target glucose increased from 6 to 9 mmol/L) up to the end of each exercise session. Plasma glucose was collected regularly. Plasma glucose times in range (3.9-10.0 mmol/L) and above range (>10.0 mmol/L) from exercise onset to 90-min-post-exercise, were similar between Ex60 and Ex120 (63.7 ± 41.4% Ex60 vs. 65.9 ±24.9% Ex120, p=0.3; 36.1 ± 41.6% Ex60 vs. 34.1 ± 24.9% Ex120, p=0.4, respectively) . No hypoglycemic events (<3.9 mmol/L) occurred during the study. The mean reduction in plasma glucose levels were similar during exercise in both conditions (-2.6 ± 1.4 mmol/L Ex60 vs. -3.5 ± 2.2 mmol/L Ex120, p=0.2) Conclusion: combining pre-meal exercise announcement with a meal bolus reduction of 33% was effective and safe at preventing postprandial exercise hypoglycemia in PWT1D treated with AID whether exercise was performed 1 or 2-h after a meal. Disclosure M.Raffray: None. R.Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc. É.Myette-côté: None. J.Molveau: None. M.Devaux: None. Z.Wu: Other Relationship; Eli Lilly and Company. Funding National Institutes of Health (A12BC345678)
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