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Dual-hormone closed loop system using a liquid stable glucagon formulation versus insulin-only closed loop system compared to a predictive low glucose suspend system: an open label, outpatient, single center, crossover, randomized control trial

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posted on 11.09.2020 by 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, Jessica R. Castle
Objective: To assess the efficacy and feasibility of a dual-hormone 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 system.

Research Design and Methods: In a 76-hour, 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) predictive low glucose suspend (PLGS). The primary endpoint was percent time in hypoglycemia (<70 mg/dL) from start of in-clinic aerobic exercise (45mins at 60% VO2max) to 4 hours after.

Results: DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [0.0-4.2], SH 8.3% [0.0-12.5], p=0.025). There was an increased time in hyperglycemia (>180mg/dL) during and after exercise for DH vs 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, 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 versus 25.1% for SH (p=0.044) and 34.7% for PLGS (p=0.140). Four participants experienced nausea related to glucagon leading 3 to withdraw from the study.

Conclusions: The glucagon formulation demonstrated feasibility in a closed loop system. The dual-hormone system reduced hypoglycemia during and after exercise with some increase in hyperglycemia.

Funding

This research was supported by JDRF IDDP grant #15-2013-505. The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

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