1038-P: Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System

Abstract

Dual-hormone systems show promise to reduce hypoglycemia, but require a stable liquid glucagon formulation. XeriSol™ glucagon is a shelf-stable glucagon product for this use. Nineteen subjects with T1D are completing a single-center three-day outpatient study comparing control modes of the Oregon Artificial Pancreas system: 1) dual hormone (DH) closed-loop with Novolog™ insulin and XeriSol™ glucagon, 2) insulin-only single hormone (SH) closed-loop, 3) insulin-only predictive low glucose suspend system (PLGS). In clinic aerobic exercise (45 minutes at 60% VO2max) and home exercise was completed with each arm. SH and DH used automated exercise detection to adaptively dose insulin/glucagon for predicted hypoglycemia and tailored mealtime dosing based on past meal responses with an adaptive algorithm. An interim analysis after 7 subjects was completed for safety. The primary outcome measures are % time 70-180 mg/dL and % time <70 mg/dL for the 3-day study and the 4-hour period from start of exercise until the next meal. From start of exercise until the next meal, DH showed a clinically meaningful reduction of time in hypoglycemia compared with PLGS and SH. For the entire study, DH showed a clinically meaningful lower time <70mg/dL. No serious events or unexpected side effects occurred. Disclosure L.M. Wilson: None. P.G. Jacobs: Stock/Shareholder; Self; Pacific Diabetes Technologies. N. Resalat: None. R. Reddy: None. J. El Youssef: None. D. Branigan: None. J.A. Leitschuh: Other Relationship; Self; AgaMatrix. B. Senf: None. V. Gabo: None. J.R. Castle: Advisory Panel; Self; Novo Nordisk Inc., Zealand Pharma A/S. Consultant; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Xeris Pharmaceuticals, Inc. Funding JDRF