TY - JOUR
T1 - 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
T2 - An open-label, outpatient, single-center, crossover, randomized controlled trial
AU - Wilson, Leah M.
AU - Jacobs, Peter G.
AU - Ramsey, Katrina L.
AU - Resalat, Navid
AU - Reddy, Ravi
AU - Branigan, Deborah
AU - Leitschuh, Joseph
AU - Gabo, Virginia
AU - Guillot, Florian
AU - Senf, Brian
AU - El Youssef, Joseph
AU - Steineck, Isabelle Isa Kristin
AU - Tyler, Nichole S.
AU - Castle, Jessica R.
N1 - Publisher Copyright:
© 2020 by the American Diabetes Association.
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
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U2 - 10.2337/dc19-2267
DO - 10.2337/dc19-2267
M3 - Article
C2 - 32907828
AN - SCOPUS:85093967814
SN - 0149-5992
VL - 43
SP - 2721
EP - 2729
JO - Diabetes care
JF - Diabetes care
IS - 11
ER -