313-OR: Outpatient Real-World Use of an Automated Insulin Delivery (AID) System That Automatically Doses for Meals Compared with Hybrid Commercial AID Systems

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Introduction and Objective: Most commercial AIDs require entry of carbohydrates before meals. This is burdensome for people with type 1 diabetes (T1D) with many forgetting to report or incorrectly estimating carbohydrates. We developed the OHSU AID with automated, machine-learning based meal detection and dosing that can be used with or without carbohydrate announcements. Methods: This multisite study evaluated 7 days of real-world use of the OHSU AID in 25 people (13 female, mean age 32.4, mean A1c 7.5%) with T1D currently using Control-IQ (24) or Omnipod5 (1) with baseline A1c or GMI above 7.5%. The OHSU AID uses the iPancreas platform, Insulet pods, and Dexcom G6 CGM. The primary outcome was to evaluate non-inferiority (7% margin) of OHSU AID (intervention) compared with usual care (control) in randomized order. Results: The OHSU AID achieved non-inferior time-in-range (70-180 mg/dL) compared to control (intervention 56.0% SD 12.0 vs. control 56.8% SD 12.7, mean within-person difference -0.8% SD 10.4). Other CGM metrics were also non-inferior. No severe adverse outcomes occurred. Conclusion: This study demonstrates potential for AIDs that maintain safety and efficacy while reducing burden for the person with diabetes by allowing automated meal dosing with flexibility to enter meal carbohydrates. Disclosure L.M. Wilson: None. C.M. Mosquera-Lopez: None. D.K. Aby-Daniel: None. S. Trikudanathan: None. J.H. Eom: None. D. Branigan: None. H. Ling: None. D. Chen: None. M. Howard: None. J.A. Leitschuh: None. W. Hilts: None. K. Ramsey: None. R. Dodier: None. J. Pinsonault: None. J. Castle: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. P.G. Jacobs: Research Support; Dexcom, Inc. Speaker's Bureau; Dexcom, Inc. Advisory Panel; Eli Lilly and Company. Stock/Shareholder; Pacific Diabetes Technologies. Research Support; SFC Fluidics, Eli Lilly and Company. Funding National Institutes of Health (R01DK120367)

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