Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: An open-label, randomised, crossover, controlled trial

2017 ◽  
Vol 19 (5) ◽  
pp. 713-720 ◽  
Author(s):  
Ahmad Haidar ◽  
Virginie Messier ◽  
Laurent Legault ◽  
Martin Ladouceur ◽  
Rémi Rabasa-Lhoret
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Controlled Trial ◽  
Artificial Pancreas ◽  
Open Label ◽  
Pump Therapy

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 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.

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 Use of a do-it-yourself artificial pancreas system is associated with better glucose management and higher quality of life among adults with type 1 diabetes

2020 ◽  
Vol 11 ◽  
pp. 204201882095014
Author(s):  
Zekai Wu ◽  
Sihui Luo ◽  
Xueying Zheng ◽  
Yan Bi ◽  
Wen Xu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Artificial Pancreas ◽  
Pump Therapy ◽  
Quality Of Life Scale ◽  
Do It Yourself ◽  
Glucose Management

Background: Previous studies show that the use of do-it-yourself artificial pancreas system (DIYAPS) may be associated with better glycemic control characterized by improved estimated hemoglobin A1c (eHbA1c) and time in range among adults with type 1 diabetes (T1D). However, few studies have demonstrated the changes in laboratory-measured HbA1c, which is a more accepted index for glycemic control, after using a DIYAPS. Methods: This is a retrospective before-after study approaching patients who reported self-use of AndroidAPS. The main inclusion criteria included: T1D; aged ⩾18 years; having complete record of ⩾3 months of continuous AndroidAPS use; with laboratory-measured HbA1c and quality of life scale data before and after 3 months of AndroidAPS use; and not pregnant. The primary outcome was the change in HbA1c between baseline and 3 months after initiation of AndroidAPS use. Results: Overall, 15 patients (10 females) were included; the median age was 32.2 years (range: 19.2–69.4), median diabetes duration was 9.7 years (range: 1.8–23.7) and median baseline HbA1c was 7.3% (range: 6.4–10.1). The 3 months of AndroidAPS use was associated with substantial reductions in HbA1c [6.79% (SD: 1.29) versus 7.63% (SD: 1.06), p = 0.002] and glycemic variability when compared with sensor-augmented pump therapy. A lower level of fear of hypoglycemia [22.13 points (SD: 6.87) versus 26.27 points (SD: 5.82), p = 0.010] was also observed after using AndroidAPS. Conclusions: The 3 months of AndroidAPS use was associated with significant improvements in glucose management and quality of life among adults with T1D.

scholarly journals Prediction of Hypoglycemia During Aerobic Exercise in Adults With Type 1 Diabetes

2019 ◽  
Vol 13 (5) ◽  
pp. 919-927 ◽  
Author(s):  
Ravi Reddy ◽  
Navid Resalat ◽  
Leah M. Wilson ◽  
Jessica R. Castle ◽  
Joseph El Youssef ◽  
...  
Keyword(s):  
Heart Rate ◽  
Type 1 Diabetes ◽  
Aerobic Exercise ◽  
Artificial Pancreas ◽  
Prediction Algorithm ◽  
Exercise Heart Rate ◽  
Pump Therapy ◽  
Validation Data ◽  
Data Set

Background: Fear of exercise related hypoglycemia is a major reason why people with type 1 diabetes (T1D) do not exercise. There is no validated prediction algorithm that can predict hypoglycemia at the start of aerobic exercise. Methods: We have developed and evaluated two separate algorithms to predict hypoglycemia at the start of exercise. Model 1 is a decision tree and model 2 is a random forest model. Both models were trained using a meta-data set based on 154 observations of in-clinic aerobic exercise in 43 adults with T1D from 3 different studies that included participants using sensor augmented pump therapy, automated insulin delivery therapy, and automated insulin and glucagon therapy. Both models were validated using an entirely new validation data set with 90 exercise observations collected from 12 new adults with T1D. Results: Model 1 identified two critical features predictive of hypoglycemia during exercise: heart rate and glucose at the start of exercise. If heart rate was greater than 121 bpm during the first 5 min of exercise and glucose at the start of exercise was less than 182 mg/dL, it predicted hypoglycemia with 79.55% accuracy. Model 2 achieved a higher accuracy of 86.7% using additional features and higher complexity. Conclusions: Models presented here can assist people with T1D to avoid exercise related hypoglycemia. The simple model 1 heuristic can be easily remembered (the 180/120 rule) and model 2 is more complex requiring computational resources, making it suitable for automated artificial pancreas or decision support systems.

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