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 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>

Artificial Pancreas With Carbohydrate Suggestion Performance for Unannounced and Announced Exercise in Type 1 Diabetes

2020 ◽  
Vol 106 (1) ◽  
pp. 55-63
Author(s):  
Clara Viñals ◽  
Aleix Beneyto ◽  
Juan-Fernando Martín-SanJosé ◽  
Clara Furió-Novejarque ◽  
Arthur Bertachi ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Pump ◽  
Artificial Pancreas ◽  
Cycle Ergometer ◽  
Open Loop ◽  
Target Range ◽  
Exercise Session ◽  
And Performance

Abstract Objective To evaluate the safety and performance of a new multivariable closed-loop (MCL) glucose controller with automatic carbohydrate recommendation during and after unannounced and announced exercise in adults with type 1 diabetes (T1D). Research Design and Methods A randomized, 3-arm, crossover clinical trial was conducted. Participants completed a heavy aerobic exercise session including three 15-minute sets on a cycle ergometer with 5 minutes rest in between. In a randomly determined order, we compared MCL control with unannounced (CLNA) and announced (CLA) exercise to open-loop therapy (OL). Adults with T1D, insulin pump users, and those with hemoglobin (Hb)A1c between 6.0% and 8.5% were eligible. We investigated glucose control during and 3 hours after exercise. Results Ten participants (aged 40.8 ± 7.0 years; HbA1c of 7.3 ± 0.8%) participated. The use of the MCL in both closed-loop arms decreased the time spent &lt;70 mg/dL of sensor glucose (0.0%, [0.0-16.8] and 0.0%, [0.0-19.2] vs 16.2%, [0.0-26.0], (%, [percentile 10-90]) CLNA and CLA vs OL respectively; P = 0.047, P = 0.063) and the number of hypoglycemic events when compared with OL (CLNA 4 and CLA 3 vs OL 8; P = 0.218, P = 0.250). The use of the MCL system increased the proportion of time within 70 to 180 mg/dL (87.8%, [51.1-100] and 91.9%, [58.7-100] vs 81.1%, [65.4-87.0], (%, [percentile 10-90]) CLNA and CLA vs OL respectively; P = 0.227, P = 0.039). This was achieved with the administration of similar doses of insulin and a reduced amount of carbohydrates. Conclusions The MCL with automatic carbohydrate recommendation performed well and was safe during and after both unannounced and announced exercise, maintaining glucose mostly within the target range and reducing the risk of hypoglycemia despite a reduced amount of carbohydrate intake. Register Clinicaltrials.gov: NCT03577158

scholarly journals Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e020275 ◽  
Author(s):  
Martin de Bock ◽  
Sybil A McAuley ◽  
Mary Binsu Abraham ◽  
Grant Smith ◽  
Jennifer Nicholas ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Standard Therapy ◽  
Closed Loop ◽  
Insulin Pump ◽  
Controlled Trial ◽  
Artificial Pancreas ◽  
Insulin Delivery ◽  
Randomised Controlled

IntroductionAutomated insulin delivery (also known as closed loop, or artificial pancreas) has shown potential to improve glycaemic control and quality of life in people with type 1 diabetes (T1D). Automated insulin delivery devices incorporate an insulin pump with continuous glucose monitoring(CGM) and an algorithm, and adjust insulin in real time. This study aims to establish the safety and efficacy of a hybrid closed-loop (HCL) system in a long-term outpatient trial in people with T1D aged 12 –<25 years of age, and compare outcomes with standard therapy for T1D as used in the contemporary community.Methods and analysisThis is an open-label, multicentre, 6-month, randomised controlled home trial to test the MiniMed Medtronic 670G system (HCL) in people with T1D aged 12 –<25 years, and compare it to standard care (multiple daily injections or continuous subcutaneous insulin infusion (CSII), with or without CGM). Following a run-in period including diabetes and carbohydrate counting education, dosage optimisation and baseline glucose control data collection, participants are randomised to either HCL or to continue on their current treatment regimen. The primary aim of the study is to compare the proportion of time spent in target sensor glucose range (3.9–10.0 mmol/L) on HCL versus standard therapy. Secondary aims include a range of glucose control parameters, psychosocial measures, health economic measures, biomarker status, user/technology interactions and healthcare professional expectations. Analysis will be intention to treat. A study in adults with an aligned design is being conducted in parallel to this trial.Ethics and disseminationEthics committee permissions were gained from respective institutional review boards. The findings of the study will provide high-quality evidence on the role of HCL in clinical practice.

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
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