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)
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: We aim to assess the difference between open-source do-it-yourself (DIY) and commercial automated insulin delivery (AID) systems in patient-reported outcomes (PRO) of adults with type 1 diabetes (T1D). Methods: Analysis from a prospective, non-inferiority, non-randomized, parallel-cohort study involving 78 non-pregnant adults with T1D, AID users ≥3 months and living in Canada. Participants (25 DIYAID and 53 commercial AID users, 60.3% females, mean age 41.2±14.6 years, mean T1D duration 27.0±14.7 years, median [Q1, Q3] duration of AID use 15.6 [7.8, 27, 4] months, mean HbA1c 6.7±0.7%, median time in range [TIR 70-180 mg/dl] 74.3% [66.8, 81.0]) completed the following validated PRO questionnaires: Diabetes Distress Scale (DDS, high distress level defined as >2.0), Diabetes Treatment Satisfaction Questionnaire (DTS-Q), An Audit of Diabetes-Dependent Quality of Life (ADD-QoL), Hypoglycemia Fear Score II (HFS-II, fear of hypoglycemia defined as scoring ≥3 in any worry subscale item), Pittsburgh Sleep Quality Index (PSQI, poor sleep defined as >5), Clarke and Gold score (hypoglycemia unawareness defined as either score ≥4). Results: DIYAID users reported better sleep quality (66.7% vs 33.3%, p=0.02) and lower HFS-II worry subscale score (28.2 vs 33.2, p=0.03) than commercial AID users, but results did not remain significant after adjusting for sex, age, level of education, T1D and AID use duration, HbA1c, and TIR. The two groups were otherwise comparable in other PROs. Overall, one third of participants reported diabetes distress, 88.3% reported poor sleep, 20.8% reported impaired hypoglycemia awareness and 80.5% reported fear of hypoglycemia. Conclusion: Similar broad QoL and other PROs were observed between DIYAID and commercial AID users, with a persistent and significant diabetes burden for all, despite advanced diabetes technology use and optimal glycemic management. Disclosure M.Lebbar: None. Z.Wu: Other Relationship; Eli Lilly and Company. A.C.Bonhoure: Consultant; Dexcom, Inc. V.Messier: 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. R.Rabasa-lhoret: Consultant; Dexcom, Inc., Abbott, Janssen Pharmaceuticals, Inc., Novo Nordisk Canada Inc., Sanofi, Lilly, Tandem Diabetes Care, Inc., Insulet Corporation. Funding Canadian Institutes of Health Research (148464)
Introduction: LADA is known for a slow progression of autoimmune destruction of beta-cells with cases that span a spectrum between classic T1D and T2D phenotypes. To date, lacking a good understanding of LADA has prohibited the release of specific clinical practice guidelines and subsequently an optimal management. Methodology: Cross-sectional analysis of online clinical questionnaires in the Canadian BETTER registry; participants can specify having received a diagnosis of LADA or T1D. Data was analyzed for the first 1464 participants; 131 (9%) reported LADA and 1333 (91%) T1D. Results: At registration; LADA vs T1D were 49 ± 13 y.o. vs 42 ± 15 y.o; 61% vs. 62% females; diabetes duration 10 ± 9 vs. 24 ± 15 years. LADA vs. T1D were older at diagnosis (39 ± 12 vs. 18 ± 12 years old; p<0.001), only half started insulin in first year of diagnosis (52 vs. 97%; p<0.001), more often reported a family history of T1D (46 vs. 32%; p=0.001). For comparable glycemic control (HbA1c < 8.6 mmol/l, <7%, 38 vs. 32%), fewer cases with LADA reported at least an episode in last month of level II hypoglycemia <54 mg/dL (3.0mmol/L) 63% vs. 77%; p= 0.004, severe hypoglycemia rates were 8% vs. 12%, p=0.15. Diabetes related hospitalizations were 10% in LADA vs. 6%, p=0.11, insulin pumps and glucagon were less used in LADA. In a matched analysis for diabetes duration and gender (1:1), glycemic control was still statistically comparable in LADA vs. T1D (HbA1c <7%: 38 vs 35%, p=0.12) as well as rates of nephropathy (6% vs. 11%, p=0.22), neuropathy (12% vs. 7%, p=0.23) and retinopathy (6% vs. 9%, p=0.07) yet with more cardiovascular disease (5% vs. 2%; p=0.02) and less coeliac disease (3 vs. 5%; p=0.001). Data analysis of 3000 participants is ongoing in early 2023. Conclusion: Reported differences may impact LADA management. This study sets the stage for building a prospective Canadian cohort of LADA to undergo deep phenotyping, genotyping and interventional trials. Disclosure M.Issa: 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. S.Haag: Other Relationship; Omnipod. A.Roy-fleming: None. V.Messier: None. N.Taleb: Consultant; Viatris Inc.
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
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