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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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Wilson, Leah M ; Jacobs, Peter G ; Ramsey, Katrina L ; Resalat, Navid ; Reddy, Ravi ; Branigan, Deborah ; Leitschuh, Joseph ; Gabo, Virginia ; Guillot, Florian ; Senf, Brian ; El Youssef, Joseph ; Steineck, Isabelle Isa Kristin ; Tyler, Nichole S ; Castle, Jessica R. / 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. I: Diabetes Care. 2020 ; Bind 43, Nr. 11. s. 2721-2729.

Bibtex

@article{99e0ed514ca247e6b6646e7fa4fb1c42,
title = "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",
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.",
author = "Wilson, {Leah M} and Jacobs, {Peter G} and Ramsey, {Katrina L} and Navid Resalat and Ravi Reddy and Deborah Branigan and Joseph Leitschuh and Virginia Gabo and Florian Guillot and Brian Senf and {El Youssef}, Joseph and Steineck, {Isabelle Isa Kristin} and Tyler, {Nichole S} and Castle, {Jessica R}",
note = "{\textcopyright} 2020 by the American Diabetes Association.",
year = "2020",
month = nov,
doi = "10.2337/dc19-2267",
language = "English",
volume = "43",
pages = "2721--2729",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association",
number = "11",

}

RIS

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 - © 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 = 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.

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 = 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.

U2 - 10.2337/dc19-2267

DO - 10.2337/dc19-2267

M3 - Journal article

C2 - 32907828

VL - 43

SP - 2721

EP - 2729

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

IS - 11

ER -

ID: 61376820