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- Title
Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial.
- Authors
Wilson, Leah M.; Jacobs, Peter G.; Ramsey, Katrina L.; Resalat, Navid; Reddy, Ravi; Branigan, Deborah; Leitschuh, Joseph; Gabo, Virginia; Guillot, Florian; Senf, Brian; El Youssef, Joseph; Steineck, Isabelle Isa Kristin; Tyler, Nichole S.; Castle, Jessica R.
- Abstract
<bold>Objective: </bold>To assess the efficacy and feasibility of a dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation compared with an insulin-only closed-loop system and a predictive low glucose suspend (PLGS) system.<bold>Research Design and Methods: </bold>In a 76-h, randomized, crossover, outpatient study, 23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system: 1) dual-hormone (DH) closed-loop control, 2) insulin-only single-hormone (SH) closed-loop control, and 3) PLGS system. The primary end point was percentage time in hypoglycemia (<70 mg/dL) from the start of in-clinic aerobic exercise (45 min at 60% VO2max) to 4 h after.<bold>Results: </bold>DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5], P = 0.025). There was an increased time in hyperglycemia (>180 mg/dL) during and after exercise for DH versus SH (20.8% DH vs. 6.3% SH, P = 0.038). Mean glucose during the entire study duration was DH, 159.2; SH, 151.6; and PLGS, 163.6 mg/dL. Across the entire study duration, DH resulted in 7.5% more time in target range (70-180 mg/dL) compared with the PLGS system (71.0% vs. 63.4%, P = 0.044). For the entire study duration, DH had 28.2% time in hyperglycemia vs. 25.1% for SH (P = 0.044) and 34.7% for PLGS (P = 0.140). Four participants experienced nausea related to glucagon, leading three to withdraw from the study.<bold>Conclusions: </bold>The glucagon formulation demonstrated feasibility in a closed-loop system. The DH system reduced hypoglycemia during and after exercise, with some increase in hyperglycemia.
- Subjects
OREGON; CLOSED loop systems; GLUCAGON; TYPE 1 diabetes; GLUCOSE; ARTIFICIAL pancreases; BLOOD sugar analysis; PILOT projects; RESEARCH; HYPERGLYCEMIA; RESEARCH methodology; SELF-evaluation; ARTIFICIAL organs; HYPOGLYCEMIC agents; BLOOD sugar; MEDICAL cooperation; EVALUATION research; INSULIN; COMPARATIVE studies; RANDOMIZED controlled trials; INSULIN pumps; EXERCISE; HYPOGLYCEMIA; CROSSOVER trials; STATISTICAL sampling; HEALTH self-care
- Publication
Diabetes Care, 2020, Vol 43, Issue 11, p2721
- ISSN
0149-5992
- Publication type
journal article
- DOI
10.2337/dc19-2267