scholarly journals Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis

2013 ◽  
Vol 15 (2) ◽  
pp. 91-99 ◽  
Author(s):  
Revital Nimri ◽  
Ido Muller ◽  
Eran Atlas ◽  
Shahar Miller ◽  
Olga Kordonouri ◽  
...  
Keyword(s):  
Glucose Control ◽  
Interim Analysis ◽  
Crossover Trial ◽  
Artificial Pancreas ◽  
Home Setting ◽  
Randomized Crossover Trial ◽  
Single Blind

Efficacy of Dual-Hormone Artificial Pancreas to Alleviate the Carbohydrate Counting Burden in Type 1 Diabetes: Randomized Crossover Trial

2014 ◽  
Vol 38 (5) ◽  
pp. S12-S13
Author(s):  
Véronique Gingras ◽  
Rémi Rabasa-Lhoret ◽  
Virginie Messier ◽  
Melika Forde ◽  
Laurent Legault ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Crossover Trial ◽  
Artificial Pancreas ◽  
Carbohydrate Counting ◽  
Randomized Crossover Trial

scholarly journals A Meal Detection Algorithm for the Artificial Pancreas: A Randomized Controlled Clinical Trial in Adolescents With Type 1 Diabetes

2020 ◽  
Author(s):  
Emilie Palisaitis ◽  
Anas El Fathi ◽  
Julia E. von Oettingen ◽  
Ahmad Haidar ◽  
Laurent Legault
Keyword(s):  
Crossover Trial ◽  
Artificial Pancreas ◽  
Detection Algorithm ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Past ◽  
Randomized Crossover Trial ◽  
Reduced Time

<a><b>Background</b>: We developed a meal detection algorithm for the artificial pancreas that detects unannounced meals and delivers an automatic insulin bolus.</a> <p> </p> <p><b>Methods</b>: We conducted a randomized crossover trial in 11 adolescents aged 12-18 years with HbA1c≥7.5% who missed≥1 bolus in the past six months. We compared (i) CSII, (ii) artificial pancreas (AP), and (iii) artificial pancreas with a meal detection algorithm (AP+MDA). Participants underwent three 9-hour interventions involving breakfast with a bolus and lunch without a bolus.</p> <p> </p> <p><b>Results</b>: In AP+MDA, the meal detection time was 40.0 [40.0–57.5] minutes. Compared to CSII, AP+MDA decreased the 4-hour post-lunch iAUC from 24.1±9.5 h.mmol/L to 15.4±8.0 h.mmol/L (p=0.03). iAUC did not differ between AP+MDA and AP (19.6±10.4 h.mmol/L, p=0.21) nor between AP and CSII (p=0.33). The AP+MDA reduced time>10mmol/L (58.0±26.6%) compared to CSII (79.6±27.5%, p=0.02) and AP (74.2±20.6%, p=0.047). </p> <p> </p> <p><b>Conclusions</b>: The AP+MDA improved glucose control after an unannounced meal.</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>

Effect of sitagliptin on glucose control in adult patients with Type 1 diabetes: a pilot, double-blind, randomized, crossover trial

2011 ◽  
Vol 28 (10) ◽  
pp. 1176-1181 ◽  
Author(s):  
S. L. Ellis ◽  
E. G. Moser ◽  
J. K. Snell-Bergeon ◽  
A. S. Rodionova ◽  
R. M. Hazenfield ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Crossover Trial ◽  
Adult Patients ◽  
Double Blind ◽  
Randomized Crossover Trial

scholarly journals Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial

2021 ◽  
Author(s):  
Charlotte K. Boughton ◽  
Afroditi Tripyla ◽  
Sara Hartnell ◽  
Aideen Daly ◽  
David Herzig ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Therapy ◽  
Primary Endpoint ◽  
Glucose Control ◽  
Closed Loop ◽  
Crossover Trial ◽  
Open Label ◽  
Randomized Crossover Trial ◽  
Target Glucose

AbstractWe evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart (‘closed-loop’) with standard insulin therapy and a masked continuous glucose monitor (‘control’) in random order. The primary endpoint was time in target glucose range (5.6–10.0 mmol l−1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0 mmol l−1; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0–22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l−1; P = 0.003). Time in hypoglycemia (<3.9 mmol l−1) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0–0.4%) versus 0.2 (0.0–0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775.

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>

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