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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.
- Source :
- Diabetes Care; Nov2020, Vol. 43 Issue 11, p2721-2729, 9p
- Publication Year :
- 2020
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 01495992
- Volume :
- 43
- Issue :
- 11
- Database :
- Complementary Index
- Journal :
- Diabetes Care
- Publication Type :
- Academic Journal
- Accession number :
- 146526376
- Full Text :
- https://doi.org/10.2337/dc19-2267