Feasibility Study of Automated Overnight Closed-Loop Glucose Control Under MD-Logic Artificial Pancreas in Patients with Type 1 Diabetes: The DREAM Project

BACKGRAUND: A closed-loop glucose control system or artificial pancreas consists of three components a Continuous Glucose Monitor (CGM), infusion pumps to deliver hormone(s) and a sophisticated dosing algorithm to control hormone delivery. In the past years, numerous studies with closed-loop system devices were conducted with gradual shift to out-of-hospital environment and with lengthening study duration. AIMS: To compare efficacy and safety of closed-loop insulin pump use in children with type 1 diabetes mellitus in compare with conventional insulin treatment (continuous subcutaneous insulin infusion (CSII) with our without CGM) based on randomized control trials data (RCT). METHODS: In the systematic review we have include 28 randomized controlled trials results indexed in PubMed, Medline databases published till 15 June 2017. The efficacy on metabolic control in this study evaluated by the proportion of time within target range (preferably 70 to 180 mg/dl if reported) and mean (median) glucose based on sensor measurements, and the safety evaluated by time in hypoglycemia (below 70 mg/dl if reported). RESULTS: Increased time in range in the night period was observed in all RCT. Only 3 RCT showed decrease of the time in range within 24 h evaluation period. In one RCT the significant positive differences have been shown in the time in range for dual hormone closed-loop glucose control system in compare with insulin-only artificial pancreas. Mean glycaemia and glucose variability changes were not in the same manner in different RCT, both in the night only and in 24 h estimation period. Night hypoglycemia duration decreased in most RCT with closed-loop control in compare with CSII, and increased only in 2 RCT. When all-day estimation period the time in hypoglycemia changed not in the same manner in different RCT. Valuable methodology differences of the glycaemic control estimation within observed RCT brought significant complications in the data analysis and made impossible the results quantitative estimation to prepare a metaanalysis. CONCLUSIONS: Much work has been done to develop effective and safe artificial pancreas, but not all RCTs confirmed advantages of closed-loop glucose control in compare with CSII in children and adolescents in real life. More research with prospective randomized control design required to prove benefits of closed-loop glucose control. Further RCTs should have an uniform methodology for glycemic control assessment and long duration that will allow to use cumulative measures in a closed-loop efficacy estimation (HbA1c).

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Realizing a Closed-Loop (Artificial Pancreas) System for the Treatment of Type 1 Diabetes

Endocrine Reviews ◽

10.1210/er.2018-00174 ◽

2019 ◽

Vol 40 (6) ◽

pp. 1521-1546 ◽

Cited By ~ 9

Author(s):

Rayhan A Lal ◽

Laya Ekhlaspour ◽

Korey Hood ◽

Bruce Buckingham

Keyword(s):

Type 1 Diabetes ◽

Glucose Control ◽

Closed Loop ◽

Diabetes Management ◽

Artificial Pancreas ◽

Loop System ◽

Closed Loop Control ◽

Closed Loop System ◽

Loop Control

Abstract Recent, rapid changes in the treatment of type 1 diabetes have allowed for commercialization of an “artificial pancreas” that is better described as a closed-loop controller of insulin delivery. This review presents the current state of closed-loop control systems and expected future developments with a discussion of the human factor issues in allowing automation of glucose control. The goal of these systems is to minimize or prevent both short-term and long-term complications from diabetes and to decrease the daily burden of managing diabetes. The closed-loop systems are generally very effective and safe at night, have allowed for improved sleep, and have decreased the burden of diabetes management overnight. However, there are still significant barriers to achieving excellent daytime glucose control while simultaneously decreasing the burden of daytime diabetes management. These systems use a subcutaneous continuous glucose sensor, an algorithm that accounts for the current glucose and rate of change of the glucose, and the amount of insulin that has already been delivered to safely deliver insulin to control hyperglycemia, while minimizing the risk of hypoglycemia. The future challenge will be to allow for full closed-loop control with minimal burden on the patient during the day, alleviating meal announcements, carbohydrate counting, alerts, and maintenance. The human factors involved with interfacing with a closed-loop system and allowing the system to take control of diabetes management are significant. It is important to find a balance between enthusiasm and realistic expectations and experiences with the closed-loop system.

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

10.2337/figshare.13283912 ◽

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 To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS 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). RESULTS 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). CONCLUSIONS 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.

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

BMJ Open ◽

10.1136/bmjopen-2017-020275 ◽

2018 ◽

Vol 8 (8) ◽

pp. e020275 ◽

Cited By ~ 7

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.

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

Diabetes Care ◽

10.2337/dc20-2106 ◽

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

10.2337/figshare.13283912.v1 ◽

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 To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS 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). RESULTS 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). CONCLUSIONS 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.

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