We did a randomized crossover non-inferiority trial to compare 3 weeks of automated insulin delivery with (i) carbohydrate counting and (ii) qualitative meal-size estimation (low, medium, high, or very high carbohydrate (CHO)) in 30 adults with T1D (20/30 females, age 44±17 yrs, A1c 7.4±0.7%) . Low, medium, high, and very high CHO meals were defined as <30 g CHO, 30-60 g CHO, 60-90 g CHO, and >90 g CHO, respectively, and their prandial insulin boluses were calculated as the individualized insulin-to-CHO ratios x 15, 35, 65, and 95, respectively. Closed-loop algorithms were otherwise identical in the two arms. The time in range 3.9-10.0 mmol/L (primary outcome) was 74% (SD 10%) with carbohydrate counting and 71% (11%) with qualitative meal-size estimation; difference -3.6% (95% CI, -0.6% to -6.5%) which crossed the pre-specified non-inferiority margin of 4%. Times <3.9 mmol/L and <3.0 mmol/L were low in both two arms. Automated basal insulin delivery was higher in the qualitative meal-size estimation arm (34.6 vs. 32.6 u/day, p=0.003) . We conclude that non-inferiority of the qualitative meal-size estimation was not confirmed, though this method achieved a high time in range and low time in hypoglycemia. The qualitative meal-size estimation method may benefit from larger prandial boluses and more responsive post-meal automatic basal delivery. Disclosure A.Haidar: Consultant; Eli Lilly and Company, Research Support; ADOCIA, Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. L.Legault: Advisory Panel; Abbott Diabetes, Insulet Corporation, Novo Nordisk A/S, Other Relationship; Eli Lilly and Company, Research Support; AstraZeneca, Merck & Co., Inc. M.Raffray: None. N.Gouchie-provencher: None. A.Jafar: None. M.Devaux: None. M.Ghanbari: 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 National Institutes of Health (1DP3DK106930-01)
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)
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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