Leah M Wilson1, Peter G Jacobs2, Katrina L Ramsey3, Navid Resalat2, Ravi Reddy2, Deborah Branigan4, Joseph Leitschuh2, Virginia Gabo4, Florian Guillot4, Brian Senf4, Joseph El Youssef4,2, Isabelle Isa Kristin Steineck5, Nichole S Tyler2, Jessica R Castle4. 1. Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR wilsolea@ohsu.edu. 2. Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR. 3. Oregon Clinical and Translational Research Institute Biostatistics and Design Program, Oregon Health & Science University & Portland State University School of Public Health, Portland, OR. 4. Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR. 5. Steno Diabetes Center Copenhagen, Gentofte, Denmark.
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 = 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. 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.
RCT Entities:
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 = 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. 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.
Authors: Marco Infante; David A Baidal; Michael R Rickels; Andrea Fabbri; Jay S Skyler; Rodolfo Alejandro; Camillo Ricordi Journal: Artif Organs Date: 2021-07-15 Impact factor: 2.663
Authors: Ingrid Anna Teigen; Marte Kierulf Åm; Sven Magnus Carlsen; Sverre Christian Christiansen Journal: Basic Clin Pharmacol Toxicol Date: 2022-04-21 Impact factor: 3.688