A Random-Order, Double- Blinded, Placebo-Controlled Study of the Bionic Pancreas in the Bihormonal vs. Insulin-Only Configurations Using Two Different Glucose Targets in Adults with Type 1 Diabetes in the Home-Use Setting

Objective: We evaluated the glycemic outcomes with 2 glucose targets in both configurations (bihormonal and insulin-only) of the bionic pancreas (BP) in a home-use study of adults with type 1 diabetes. Research Design and Methods: 20 participants completed a double-blinded, placebo-controlled (glucagon vs. placebo), random-order, four-arm cross-over trial comparing the bihormonal (BH) and insulin-only (IO) configurations of the BP, each using 2 glucose targets (110 and 130 mg/dl); each arm lasted 3 days. Co-primary outcomes were continuous glucose monitor (CGM) mean glucose level and time <54 mg/dl. Results: For the BH vs. IO configurations using the 130 mg/dl glucose target, the mean CGM glucose was 156±12 vs. 161±17 mg/dl (p=0.11) and the median percentage of time with CGM glucose <54 mg/dl was 0.0% [IQR 0-0.52%] vs. 0.0% [0-0.35%] (p=0.45). For the BH vs. IO configurations using the 110 mg/dl glucose target, the mean CGM glucose was 148±17 vs. 153±15 mg/dl (p=0.21) and the median percentage of time with CGM glucose <54 mg/dl was 0.0% [0-0%] vs. 0.52% [0.0-1.0%] (p=0.002). The nominal differences in mean CGM glucose between the 110 mg/dl and the 130 mg/dl glucose targets (8 mg/dl in each case) were not statistically significant in either the IO or BH configuration (p>0.05). There was less hypoglycemia in the IO configuration, but not the BH configuration, when using the 130 mg/dl target vs. the 110 mg/dl target (p=0.03). Conclusions: Both configurations of the BP provided safe and effective glycemic control using both glucose targets during home use. Hypoglycemia was lower with the BH configuration vs. the IO configuration using the 110 mg/dl target. Hypoglycemia was lower in the IO configuration when using the 130 mg/dl target vs. the 110 mg/dl target. Larger and longer studies will be needed to quantify differences in outcomes between the IO and BH configurations of the BP. Disclosure L. E. Castellanos: None. C. A. Balliro: Consultant; Self; Beta Bionics, Inc., Novo Nordisk. J. Sherwood: None. M. Tuffaha: None. M. Hillard: None. R. Selagamsetty: Employee; Self; Beta Bionics, Inc. F. El-khatib: Employee; Self; Beta Bionics, Inc., Stock/Shareholder; Self; Beta Bionics, Inc. E. Damiano: Other Relationship; Self; Beta Bionics, Inc., Stock/Shareholder; Spouse/Partner; Beta Bionics, Inc. S. J. Russell: Advisory Panel; Self; Companion Medical, ConvaTec Inc., Consultant; Self; Beta Bionics, Inc., Novo Nordisk, Other Relationship; Self; Beta Bionics, Inc., Research Support; Self; Beta Bionics, Inc., Novo Nordisk, Zealand Pharma A/S.