Background: Carb-counting is a significant burden for persons with diabetes who require insulin to mitigate postprandial hyperglycemia. A closed-loop (CL) system with auto meal-bolus that eliminates manual mealtime bolusing was studied in adults with T1D. Methods: The system included the MiniMed™ 780G pump and a smartphone-paired smartwatch with the KLUE application that detects eating hand-gestures using motion sensors. A smartphone algorithm converted eating hand-gestures to carb amounts that were relayed to the pump for automatic bolusing. For 6 days, participants (N=17, aged 18-75 years) with T1D used the system with the KLUE app disabled and completed traditional carb-counting and -entry (Baseline) . Thereafter, the KLUE app was enabled for 5 days and carb-counting/carb-entry was prohibited (Study) . Participants were given the same 5 test-meals (one/day) of varying caloric and carb sizes during both periods. Otherwise, they had no other meal restrictions. Results: No significant difference in TIR was observed between periods and time spent at <70 mg/dL was significantly less during the Study period (Table) . Conclusion: Data suggest that the novel CL system maintains glycemic control similar to that with manual meal bolusing. By eliminating the burden of carb-counting, the new CL system may improve the quality of life in persons with T1D. Disclosure A.Roy: Employee; Medtronic. A.Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi, Consultant; Bayer AG, DreaMed Diabetes, Ltd., Research Support; Medtronic, Speaker's Bureau; Eli Lilly and Company. B.Grosman: Employee; Medtronic. D.Miller: Employee; Medtronic. T.Engel: None. O.Cohen: Employee; Medtronic. R.Shalit: Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk. S.Shalem: None. M.Laron hirsh: None. Y.Cohen: None.
Background and Aims: Meal management is a major challenge for people with type 1 diabetes (PWD) . We aimed to explore 3 approaches to complex meal planning, from a most comprehensive scheme in open loop (OL) to a simplified, carbohydrate (CHO) counting-free scheme when using the MiniMed™ 780G system AHCL. Methods: Participants (N=13, mean age 46.8±12.8 years and baseline A1C of 6.1±1.2%) consumed a high fat, high protein, meal using 3 types of insulin boluses;1) OL utilizing the dual-wave bolus and elaborate CHO counting;2) AHCL with accurate CHO amount;3) AHCL with a predefined bolus and no CHO counting, Results: No significant differences in TIR and 5-hour iAUC were observed between the 3 bolus groups (P=0.401, P=0.526, respectively) There were no significant differences in other glucose metrics. (Table 1) Conclusion: Our results indicate that glycemic control following a complex meal challenge is similar when using AHCL with or without accurate CHO counting and with less tendency for hypoglycemia when compared with the most elaborate meal management in OL. Thus, the current burden of meal management for PWD during OL system use is alleviated with AHCL. Disclosure M.Laron hirsh: None. R.Shalit: Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk. S.Shalem: None. O.Cohen: Employee; Medtronic. N.Kurtz: Employee; Medtronic. A.Roy: Employee; Medtronic. B.Grosman: Employee; Medtronic. T.Cukierman-yaffe: Research Support; European Association for the Study of Diabetes, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk, Speaker's Bureau; AstraZeneca, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk, Sanofi. A.Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi, Consultant; Bayer AG, DreaMed Diabetes, Ltd., Research Support; Medtronic, Speaker's Bureau; Eli Lilly and Company.
Objective: The Medtronic Extended infusion set (EIS) is the first and only infusion set approved for up to 7-day use. Prior studies established clinical safety and efficacy of the EIS. The purpose of this retrospective analysis was to assess real-world data on the EIS performance and user behaviors associated with the EIS including wear duration and asynchronous reservoir changes. Methods: A limited launch of the EIS outside the US (OUS) included MiniMed™ 640G/670G/780G users. Due to regional legal requirements, aggregated pump data from EIS users were not separated from other user data. To identify EIS users, an algorithm was developed based on the expected behavior patterns associated with an infusion set change, e.g., tubing fills. From the same cohort, individuals using the EIS (n=108) versus regular 3-day sets (n=414) were identified by a mean or median time between substantial tubing fills. To assess synchronous and asynchronous set/reservoir changes, reservoir changes were determined based on pump rewind commands in the CareLink™ system. Results: Mean EIS use lifetime was 6.74 days, with >70% of sets used for more than 6 days. No user complaint was received during limited launch. The EIS set change rate at 7 days (168 hrs) was 48.2%, and was comparable to the 48.9% rate of 3-day sets at 3 days (72 hrs). In addition, CareLink™ data indicated that while users with a total daily dose (TDD) of insulin less than 40 U may not require an asynchronous reservoir fill, some users with higher TDD did asynchronously and successfully change their reservoirs while retaining the infusion set. Conclusion: In the OUS limited EIS launch, the EIS performed similarly to the pivotal trial results, with no user complaints. As expected, pump users with TDD less than 40 U changed the infusion set and reservoir at the same time on the seventh day. The product has launched in the US and may potentially reduce user burden by effectively halving the number of required infusion set changes compared to standard 3-day sets. Disclosure T.Kwa: Employee; Medtronic. G.Zhang: Employee; Medtronic. A.Roy: Employee; Medtronic. M.Liu: Employee; Medtronic. E.Anselmo: Employee; Medtronic. J.Shin: Employee; Medtronic. O.Cohen: Employee; Medtronic. S.Chattaraj: Employee; Medtronic.
Background: We compared glycemic outcomes and participant experience during MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system use while announcing all meals vs. announcing meals at will. Methods: Participants with T1DM used the AHCL system at home during two 90 days phases in which they were given instructions first to announce all meals (AM) , and next, for meals containing up to 80 grams of carbohydrates, to announce meals at will (AMW) . Results: Fourteen subjects (males, mean age 44.3±11) with T1DM were enrolled, with a baseline A1C of 6.9±1%. Table 1 summarizes glycemic indices and AHCL data, demonstrating that patients chose to bolus only slightly less during AMW compared to AM (5.5 vs. 5.2 boluses) , without resultant deterioration in glycemic indices (A1c 6.4 vs. 6.5%, TIR 78.1 vs. 78.8%, p=ns) . Subjects surveyed regarding the option not to have to bolus for all meals experienced a significant reduction in reported effort to manage diabetes (p=0.045) and 86% endorsed worrying less about their diabetes. Most (93%) preferred the AMW phase of the study. Conclusion: The MinMed™ AHCL system is designed for optimal performance with meal announcement. Nonetheless, when meals containing < 80 grams of carbohydrates are consumed with announcement of meals at will, there is a slight reduction in the number of daily boluses with no decline in glycemic control, yet markedly less diabetes related distress and improved treatment satisfaction. Disclosure N. Minsky: None. R. Shalit: Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk. O. Cohen: Employee; Medtronic. N. Kurtz: Employee; Medtronic. A. Roy: Employee; Medtronic. B. Grosman: Employee; Medtronic. A. Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi. Consultant; Bayer AG, DreaMed Diabetes, Ltd. Research Support; Medtronic. Speaker's Bureau; Eli Lilly and Company.
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