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
| العنوان: | 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 |
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| المؤلفون: | Virginia Gabo, Ravi Reddy, Peter G. Jacobs, Deborah Branigan, Brian Senf, Navid Resalat, Florian H. Guillot, Katrina Ramsey, Nichole S. Tyler, Jessica R. Castle, Joseph El Youssef, Joseph Leitschuh, Isabelle Isa Kristin Steineck, Leah M. Wilson |
| المصدر: | Diabetes Care. 43:2721-2729 |
| بيانات النشر: | American Diabetes Association, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, Pancreas, Artificial, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Urology, 030209 endocrinology & metabolism, Hypoglycemia, Artificial pancreas, Glucagon, Oregon, Young Adult, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Diabetes mellitus, Outpatients, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Exercise physiology, Exercise, Advanced and Specialized Nursing, Type 1 diabetes, Cross-Over Studies, business.industry, Middle Aged, medicine.disease, Crossover study, Diabetes Mellitus, Type 1, Hyperglycemia, Feasibility Studies, Female, business |
| الوصف: | 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 ( 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. |
| تدمد: | 1935-5548 0149-5992 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::239d793cfe1b212548d7861dba424a0dTest https://doi.org/10.2337/dc19-2267Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....239d793cfe1b212548d7861dba424a0d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19355548 01495992 |
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