978-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Adults and Adolescents without Increasing Risk of Hypoglycemia

Abstract

Customization of glucose targets in hybrid closed-loop (HCL) systems is important to enable tailored glucose management and safe onboarding across a wide range of users. The safety and performance of the Omnipod HCL personalized model predictive control (MPC) algorithm were assessed with a lower target of 110mg/dL for the first time in those aged 12-85y with type 1 diabetes (T1D) and A1C<10.0% using an investigational device. A 96-h HCL study was conducted in a supervised free-living hotel setting with challenges including 2 missed meal boluses, high fat dinner, and daily exercise. All participants used a 120mg/dL target for 48h, with either a day/night target of 150/110 mg/dL (n=10) or a constant 110mg/dL target (n=10) for the remaining 48h. Participants (n=20) were (mean±SD): age 17.9±4.4y, T1D duration 9.0±5.4y, and A1C 7.6±0.9%. Despite 2 missed meal boluses (23-162g CHO), percent time from 70-180mg/dL was 76.1±14.9% and 72.9±9.2% with targets of 110 and 120mg/dL respectively (Table). Percent time <70mg/dL was low: 2.3±2.1% and 1.9±2.5% at the respective targets. The Omnipod personalized MPC algorithm performed well and was safe in adults and adolescents with T1D when tested at a target of 110mg/dL, even when stress-tested under challenging conditions. This algorithm is being evaluated in an at-home pivotal study with targets 110-150mg/dL. Disclosure G.P. Forlenza: Advisory Panel; Self; Medtronic. Consultant; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Cecelia Health. Consultant; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi, T1D Exchange. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company, Medtronic. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk Inc., Tandem Diabetes Care. A. Galderisi: None. L. Ekhlaspour: None. C. Berget: None. L. Hsu: Stock/Shareholder; Self; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care. M. Zgorski: None. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: None. B. Dumais: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation