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 children aged 2-12y with type 1 diabetes (T1D) using an investigational device.
Participants with A1C<10.0% completed a 72-96h HCL study conducted in a supervised free-living hotel setting. At HCL start, the glucose target was 120mg/dL, and was lowered to 110mg/dL after 24-48h. There were 1-2 missed lunch boluses, high fat meals, and daily exercise.
Participants (n=12) were (mean±SD): age 6.8±3.1y, T1D duration 3.7±2.9y, and A1C 7.1±0.7%. Despite 1-2 missed meal bolus challenges (mean 43g, range 18-88g CHO), percent time 70-180mg/dL was 76.6±7.2% and 80.4±9.9% with targets of 110mg/dL and 120mg/dL respectively. Outcomes were similar between the targets for mean glucose and time in glycemic ranges (Table). There were no serious adverse events.
The Omnipod personalized MPC algorithm performed well and was safe in children aged 2-12y 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.
J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Cecelia Health. Consultant; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi, T1D Exchange. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. 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. A. Galderisi: None. L. Ekhlaspour: None. 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. M. Zgorski: None. R.S. Kingman: None. C. Berget: 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.