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

Leah M. Wilson, Peter G. Jacobs, Katrina L. Ramsey, Navid Resalat, Ravi Reddy, Deborah Branigan, Joseph Leitschuh, Virginia Gabo, Florian Guillot, Brian Senf, Joseph El Youssef, Isabelle Isa Kristin Steineck, Nichole S. Tyler, Jessica R. Castle

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

OBJECTIVE 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. RESEARCH DESIGN AND METHODS 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. RESULTS 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 5 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 5 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 5 0.044). For the entire study duration, DH had 28.2% time in hyperglycemia vs. 25.1% for SH (P 5 0.044) and 34.7% for PLGS (P 5 0.140). Four participants experienced nausea related to glucagon, leading three to withdraw from the study. CONCLUSIONS The glucagon formulation demonstrated feasibility in a closed-loop system. The DH system reduced hypoglycemia during and after exercise, with some increase in hyperglycemia.

Original languageEnglish (US)
Pages (from-to)2721-2729
Number of pages9
JournalDiabetes care
Volume43
Issue number11
DOIs
StatePublished - Nov 2020

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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