212-OR: Closed-Loop Increases Time-in-Range in Older Adults with Type 1 Diabetes Compared with Sensor-Augmented Pump Therapy: A Randomized Crossover Trial

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 212-OR
Author(s):  
SYBIL A. MCAULEY ◽  
SARA VOGRIN ◽  
STEVEN TRAWLEY ◽  
PETER G. COLMAN ◽  
SPIROS FOURLANOS ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Pump Therapy ◽  
Randomized Crossover Trial ◽  
Time In Range

scholarly journals Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

Diabetes Care ◽  
2021 ◽  
pp. dc211667
Author(s):  
Sybil A. McAuley ◽  
Steven Trawley ◽  
Sara Vogrin ◽  
Glenn M. Ward ◽  
Spiros Fourlanos ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Pump Therapy ◽  
Randomized Crossover Trial

scholarly journals Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

2021 ◽  
Author(s):  
Sybil A McAuley ◽  
Steven Trawley ◽  
Sara Vogrin ◽  
Glenn M Ward ◽  
Spiros Fourlanos ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Diabetes Duration ◽  
Pump Therapy ◽  
Percentage Points ◽  
Pump Stage

Objective <p>To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes.</p> <h2>Research Design and Methods</h2> <p>This open-label randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range <a>(TIR; 3.9–10.0 mmol/L</a>).</p> <h2>Results</h2> <p>Thirty participants (mean age 67 years [SD 5]; median type 1 diabetes duration 38 years [IQR 20–47]) were randomized, <i>n</i>=15 to each sequence; all completed the trial. The mean TIR was 75.2% (6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference 6.2 percentage points [95% CI 4.4, 8.0]; <i>P</i> <0.0001). All prespecified CGM metrics favored closed loop over sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (0.3, 1.1; <i>P</i> = 0.0005) and overnight by 0.8 percentage points (0.4, 1.1; <i>P</i> <0.0001) compared with sensor-augmented pump. There was no significant difference in HbA<sub>1c</sub> between closed-loop versus sensor-augmented pump stages (7.3% [7.1–7.5] | 56 mmol/mol [54–59] versus 7.5% [7.1–7.9] | 59 mmol/mol [54–62], respectively; <i>P</i> = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage.</p> <h2>Conclusion</h2> <p>Closed-loop therapy is an effective treatment option for older adults with long duration type 1 diabetes and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed-loop than sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight. </p>

scholarly journals Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial

2021 ◽  
Author(s):  
Sybil A McAuley ◽  
Steven Trawley ◽  
Sara Vogrin ◽  
Glenn M Ward ◽  
Spiros Fourlanos ◽  
...  
Keyword(s):  
Older Adults ◽  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Insulin Delivery ◽  
Diabetes Duration ◽  
Pump Therapy ◽  
Percentage Points ◽  
Pump Stage

Objective <p>To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes.</p> <h2>Research Design and Methods</h2> <p>This open-label randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range <a>(TIR; 3.9–10.0 mmol/L</a>).</p> <h2>Results</h2> <p>Thirty participants (mean age 67 years [SD 5]; median type 1 diabetes duration 38 years [IQR 20–47]) were randomized, <i>n</i>=15 to each sequence; all completed the trial. The mean TIR was 75.2% (6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference 6.2 percentage points [95% CI 4.4, 8.0]; <i>P</i> <0.0001). All prespecified CGM metrics favored closed loop over sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (0.3, 1.1; <i>P</i> = 0.0005) and overnight by 0.8 percentage points (0.4, 1.1; <i>P</i> <0.0001) compared with sensor-augmented pump. There was no significant difference in HbA<sub>1c</sub> between closed-loop versus sensor-augmented pump stages (7.3% [7.1–7.5] | 56 mmol/mol [54–59] versus 7.5% [7.1–7.9] | 59 mmol/mol [54–62], respectively; <i>P</i> = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage.</p> <h2>Conclusion</h2> <p>Closed-loop therapy is an effective treatment option for older adults with long duration type 1 diabetes and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed-loop than sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight. </p>

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

Overnight automated type 1 diabetes control under MD-logic closed-loop system: a randomized crossover trial

2013 ◽  
pp. n/a-n/a ◽  
Author(s):  
Revital Nimri ◽  
Thomas Danne ◽  
Olga Kordonouri ◽  
Eran Atlas ◽  
Natasa Bratina ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Crossover Trial ◽  
Loop System ◽  
Diabetes Control ◽  
Closed Loop System ◽  
System A ◽  
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>

Sign in / Sign up

Export Citation Format

Share Document