Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial

Diabetes Care ◽  
2021 ◽  
pp. dc202106
Author(s):  
Helga Blauw ◽  
A. Joannet Onvlee ◽  
Michel Klaassen ◽  
Arianne C. van Bon ◽  
J. Hans DeVries
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Closed Loop ◽  
Crossover Trial ◽  
Artificial Pancreas ◽  
Randomized Crossover Trial

scholarly journals A Randomized Crossover Trial Comparing Glucose Control During Moderate-Intensity, High-Intensity, and Resistance Exercise With Hybrid Closed-Loop Insulin Delivery While Profiling Potential Additional Signals in Adults With Type 1 Diabetes

2021 ◽  
Author(s):  
Barbora Paldus ◽  
Dale Morrison ◽  
Dessi P. Zaharieva ◽  
Melissa H. Lee ◽  
Hannah Jones ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
High Intensity ◽  
Kinetic Data ◽  
Closed Loop ◽  
Crossover Trial ◽  
Moderate Intensity ◽  
Post Exercise ◽  
Randomized Crossover Trial

<b>Objective</b>: To compare glucose control with hybrid closed loop (HCL) when challenged by moderate-intensity exercise (MIE), high-intensity intermittent exercise (HIE) and resistance exercise (RE) while profiling counter-regulatory hormones, lactate, ketones, and kinetic data in adults with type 1 diabetes. <p><b>Methods</b>: <a>Open-label multisite randomized crossover trial. </a><a>Adults with type 1 diabetes undertook 40 min of HIE, MIE, and RE in random order while using HCL (Medtronic 670G) with a temporary target set 2 hours prior to and during exercise and 15g carbohydrates if pre-exercise glucose was <126mg/dL, to prevent hypoglycemia.</a> Primary outcome was median (IQR) continuous glucose monitoring (CGM) time-in-range (TIR, 70-180 mg/dL) for 14 hours post-exercise commencement. Accelerometer data and venous glucose, ketones, lactate, and counter-regulatory hormones were measured for 280 min post-exercise commencement. </p> <p><b>Results</b>: Median TIR was 81% [67, 93]%, 91% [80, 94]%, and 80% [73, 89]% for 0-14 hours post-exercise commencement for HIE, MIE and RE, respectively (n=30), with no difference between exercise types (MIE v HIE; p=0.11, MIE v RE p=0.11, HIE v RE p=0.90). Time-below-range was 0% for all exercise bouts. For HIE and RE compared with MIE, there were greater increases respectively in noradrenaline (p=0.01, p=0.004), cortisol (p<0.001, p=0.001), lactate (p£0.001, p£0.001) and heart rate (p=0.007, p=0.015). During HIE compared with MIE, there were greater increases in growth hormone (p=0.024). </p> <p><b>Conclusions</b>: Under controlled conditions, HCL provided satisfactory glucose control with no difference between exercise type. Lactate, counter-regulatory hormones, and kinetic data differentiate type and intensity of exercise, and their measurement may help inform insulin needs during exercise. However, their potential utility as modulators of insulin dosing will be limited by the pharmacokinetics of subcutaneous insulin delivery. </p>

scholarly journals A Randomized Crossover Trial Comparing Glucose Control During Moderate-Intensity, High-Intensity, and Resistance Exercise With Hybrid Closed-Loop Insulin Delivery While Profiling Potential Additional Signals in Adults With Type 1 Diabetes

2021 ◽  
Author(s):  
Barbora Paldus ◽  
Dale Morrison ◽  
Dessi P. Zaharieva ◽  
Melissa H. Lee ◽  
Hannah Jones ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
High Intensity ◽  
Kinetic Data ◽  
Closed Loop ◽  
Crossover Trial ◽  
Moderate Intensity ◽  
Post Exercise ◽  
Randomized Crossover Trial

<b>Objective</b>: To compare glucose control with hybrid closed loop (HCL) when challenged by moderate-intensity exercise (MIE), high-intensity intermittent exercise (HIE) and resistance exercise (RE) while profiling counter-regulatory hormones, lactate, ketones, and kinetic data in adults with type 1 diabetes. <p><b>Methods</b>: <a>Open-label multisite randomized crossover trial. </a><a>Adults with type 1 diabetes undertook 40 min of HIE, MIE, and RE in random order while using HCL (Medtronic 670G) with a temporary target set 2 hours prior to and during exercise and 15g carbohydrates if pre-exercise glucose was <126mg/dL, to prevent hypoglycemia.</a> Primary outcome was median (IQR) continuous glucose monitoring (CGM) time-in-range (TIR, 70-180 mg/dL) for 14 hours post-exercise commencement. Accelerometer data and venous glucose, ketones, lactate, and counter-regulatory hormones were measured for 280 min post-exercise commencement. </p> <p><b>Results</b>: Median TIR was 81% [67, 93]%, 91% [80, 94]%, and 80% [73, 89]% for 0-14 hours post-exercise commencement for HIE, MIE and RE, respectively (n=30), with no difference between exercise types (MIE v HIE; p=0.11, MIE v RE p=0.11, HIE v RE p=0.90). Time-below-range was 0% for all exercise bouts. For HIE and RE compared with MIE, there were greater increases respectively in noradrenaline (p=0.01, p=0.004), cortisol (p<0.001, p=0.001), lactate (p£0.001, p£0.001) and heart rate (p=0.007, p=0.015). During HIE compared with MIE, there were greater increases in growth hormone (p=0.024). </p> <p><b>Conclusions</b>: Under controlled conditions, HCL provided satisfactory glucose control with no difference between exercise type. Lactate, counter-regulatory hormones, and kinetic data differentiate type and intensity of exercise, and their measurement may help inform insulin needs during exercise. However, their potential utility as modulators of insulin dosing will be limited by the pharmacokinetics of subcutaneous insulin delivery. </p>

scholarly journals Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial

2021 ◽  
Author(s):  
Helga Blauw ◽  
A. Joannet Onvlee ◽  
Michel Klaassen ◽  
Arianne C. van Bon ◽  
J. Hans DeVries
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Closed Loop ◽  
Insulin Pump ◽  
Artificial Pancreas ◽  
Open Loop ◽  
Insulin Pump Therapy ◽  
Pump Therapy ◽  
Randomized Crossover Trial

OBJECTIVE <p>To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes.</p> <p> </p>RESEARCH DESIGN AND METHODS <p>In this outpatient, randomized, crossover trial, two-week fully closed loop glucose control (artificial pancreas therapy) was compared to two-week open loop control (patient’s normal insulin pump therapy with a glucose sensor if they had one). </p> <p> </p>RESULTS <p>Twenty three patients were included in the analysis. Median (IQR) time in range (70-180 mg/dL [3.9-10 mmol/L]) was significantly higher during closed loop (86.6% [84.9-88.5]) compared with open loop (53.9% [49.7-67.2]; p<0.0001).</p> <p> </p>CONCLUSIONS <p>Compared to insulin pump therapy, the bihormonal artificial pancreas provided superior glucose control, without meal or exercise announcements, and was safe in adults with type 1 diabetes.</p>

scholarly journals Restricted AccessA Randomized Crossover Trial Comparing Glucose Control During Moderate-Intensity, High-Intensity, and Resistance Exercise With Hybrid Closed-Loop Insulin Delivery While Profiling Potential Additional Signals in Adults With Type 1 Diabetes

2021 ◽  
Author(s):  
Barbora Paldus ◽  
Dale Morrison ◽  
Dessi P. Zaharieva ◽  
Melissa H. Lee ◽  
Hannah Jones ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
High Intensity ◽  
Kinetic Data ◽  
Closed Loop ◽  
Crossover Trial ◽  
Moderate Intensity ◽  
Post Exercise ◽  
Randomized Crossover Trial

<b>Objective</b>: To compare glucose control with hybrid closed loop (HCL) when challenged by moderate-intensity exercise (MIE), high-intensity intermittent exercise (HIE) and resistance exercise (RE) while profiling counter-regulatory hormones, lactate, ketones, and kinetic data in adults with type 1 diabetes. <p><b>Methods</b>: <a>Open-label multisite randomized crossover trial. </a><a>Adults with type 1 diabetes undertook 40 min of HIE, MIE, and RE in random order while using HCL (Medtronic 670G) with a temporary target set 2 hours prior to and during exercise and 15g carbohydrates if pre-exercise glucose was <126mg/dL, to prevent hypoglycemia.</a> Primary outcome was median (IQR) continuous glucose monitoring (CGM) time-in-range (TIR, 70-180 mg/dL) for 14 hours post-exercise commencement. Accelerometer data and venous glucose, ketones, lactate, and counter-regulatory hormones were measured for 280 min post-exercise commencement. </p> <p><b>Results</b>: Median TIR was 81% [67, 93]%, 91% [80, 94]%, and 80% [73, 89]% for 0-14 hours post-exercise commencement for HIE, MIE and RE, respectively (n=30), with no difference between exercise types (MIE v HIE; p=0.11, MIE v RE p=0.11, HIE v RE p=0.90). Time-below-range was 0% for all exercise bouts. For HIE and RE compared with MIE, there were greater increases respectively in noradrenaline (p=0.01, p=0.004), cortisol (p<0.001, p=0.001), lactate (p£0.001, p£0.001) and heart rate (p=0.007, p=0.015). During HIE compared with MIE, there were greater increases in growth hormone (p=0.024). </p> <p><b>Conclusions</b>: Under controlled conditions, HCL provided satisfactory glucose control with no difference between exercise type. Lactate, counter-regulatory hormones, and kinetic data differentiate type and intensity of exercise, and their measurement may help inform insulin needs during exercise. However, their potential utility as modulators of insulin dosing will be limited by the pharmacokinetics of subcutaneous insulin delivery. </p>

scholarly journals Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial

2021 ◽  
Author(s):  
Helga Blauw ◽  
A. Joannet Onvlee ◽  
Michel Klaassen ◽  
Arianne C. van Bon ◽  
J. Hans DeVries
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Closed Loop ◽  
Insulin Pump ◽  
Artificial Pancreas ◽  
Open Loop ◽  
Insulin Pump Therapy ◽  
Pump Therapy ◽  
Randomized Crossover Trial

OBJECTIVE <p>To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes.</p> <p> </p>RESEARCH DESIGN AND METHODS <p>In this outpatient, randomized, crossover trial, two-week fully closed loop glucose control (artificial pancreas therapy) was compared to two-week open loop control (patient’s normal insulin pump therapy with a glucose sensor if they had one). </p> <p> </p>RESULTS <p>Twenty three patients were included in the analysis. Median (IQR) time in range (70-180 mg/dL [3.9-10 mmol/L]) was significantly higher during closed loop (86.6% [84.9-88.5]) compared with open loop (53.9% [49.7-67.2]; p<0.0001).</p> <p> </p>CONCLUSIONS <p>Compared to insulin pump therapy, the bihormonal artificial pancreas provided superior glucose control, without meal or exercise announcements, and was safe in adults with type 1 diabetes.</p>

scholarly journals Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial

Diabetologia ◽  
2017 ◽  
Vol 60 (11) ◽  
pp. 2157-2167 ◽  
Author(s):  
Klemen Dovc ◽  
Maddalena Macedoni ◽  
Natasa Bratina ◽  
Dusanka Lepej ◽  
Revital Nimri ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 1 Diabetes ◽  
Young People ◽  
Glucose Control ◽  
Closed Loop ◽  
Crossover Trial ◽  
Randomised Controlled

2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial

2015 ◽  
Vol 3 (12) ◽  
pp. 939-947 ◽  
Author(s):  
Jort Kropff ◽  
Simone Del Favero ◽  
Jerome Place ◽  
Chiara Toffanin ◽  
Roberto Visentin ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Closed Loop ◽  
Crossover Trial ◽  
Living Conditions ◽  
Free Living ◽  
Free Living Conditions

scholarly journals Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial

Diabetes Care ◽  
2016 ◽  
Vol 39 (11) ◽  
pp. 2019-2025 ◽  
Author(s):  
Martin Tauschmann ◽  
Janet M. Allen ◽  
Malgorzata E. Wilinska ◽  
Hood Thabit ◽  
Carlo L. Acerini ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Free Living ◽  
Randomized Crossover Trial
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