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

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 <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

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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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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

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The Bio-inspired Artificial Pancreas for Type 1 Diabetes Control in the Home: System Architecture and Preliminary Results

Journal of Diabetes Science and Technology ◽

10.1177/1932296819881456 ◽

2019 ◽

Vol 13 (6) ◽

pp. 1017-1025 ◽

Cited By ~ 1

Author(s):

Pau Herrero ◽

Mohamed El-Sharkawy ◽

John Daniels ◽

Narvada Jugnee ◽

Chukwuma N. Uduku ◽

...

Keyword(s):

Clinical Trials ◽

Type 1 Diabetes ◽

Home Environment ◽

Closed Loop ◽

Artificial Pancreas ◽

Target Range ◽

Cell Physiology ◽

Handheld Device ◽

Preliminary Results

Background: Artificial pancreas (AP) technology has been proven to improve glucose and patient-centered outcomes for people with type 1 diabetes (T1D). Several approaches to implement the AP have been described, clinically evaluated, and in one case, commercialized. However, none of these approaches has shown a clear superiority with respect to others. In addition, several challenges still need to be solved before achieving a fully automated AP that fulfills the users’ expectations. We have introduced the Bio-inspired Artificial Pancreas (BiAP), a hybrid adaptive closed-loop control system based on beta-cell physiology and implemented directly in hardware to provide an embedded low-power solution in a dedicated handheld device. In coordination with the closed-loop controller, the BiAP system incorporates a novel adaptive bolus calculator which aims at improving postprandial glycemic control. This paper focuses on the latest developments of the BiAP system for its utilization in the home environment. Methods: The hardware and software architectures of the BiAP system designed to be used in the home environment are described. Then, the clinical trial design proposed to evaluate the BiAP system in an ambulatory setting is introduced. Finally, preliminary results corresponding to two participants enrolled in the trial are presented. Results: Apart from minor technical issues, mainly due to wireless communications between devices, the BiAP system performed well (~88% of the time in closed-loop) during the clinical trials conducted so far. Preliminary results show that the BiAP system might achieve comparable glycemic outcomes to the existing AP systems (~73% time in target range 70-180 mg/dL). Conclusion: The BiAP system is a viable platform to conduct ambulatory clinical trials and a potential solution for people with T1D to control their glucose control in a home environment.

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Closed-Loop Artificial Pancreas Using Subcutaneous Glucose Sensing and Insulin Delivery and a Model Predictive Control Algorithm: The Virginia Experience

Journal of Diabetes Science and Technology ◽

10.1177/193229680900300506 ◽

2009 ◽

Vol 3 (5) ◽

pp. 1031-1038 ◽

Cited By ~ 129

Author(s):

William L. Clarke ◽

Stacey Anderson ◽

Marc Breton ◽

Stephen Patek ◽

Laurissa Kashmer ◽

...

Keyword(s):

Type 1 Diabetes ◽

Predictive Control ◽

Insulin Infusion ◽

Closed Loop ◽

Artificial Pancreas ◽

Open Loop ◽

Closed Loop Control ◽

Open Loop Control ◽

Loop Control

Background: Recent progress in the development of clinically accurate continuous glucose monitors (CGMs), automated continuous insulin infusion pumps, and control algorithms for calculating insulin doses from CGM data have enabled the development of prototypes of subcutaneous closed-loop systems for controlling blood glucose (BG) levels in type 1 diabetes. The use of a new personalized model predictive control (MPC) algorithm to determine insulin doses to achieve and maintain BG levels between 70 and 140 mg/dl overnight and to control postprandial BG levels is presented. Methods: Eight adults with type 1 diabetes were studied twice, once using their personal open-loop systems to control BG overnight and for 4 h following a standardized meal and once using a closed-loop system that utilizes the MPC algorithm to control BG overnight and for 4 h following a standardized meal. Average BG levels, percentage of time within BG target of 70–140 mg/dl, number of hypoglycemia episodes, and postprandial BG excursions during both study periods were compared. Results: With closed-loop control, once BG levels achieved the target range (70–140 mg/dl), they remained within that range throughout the night in seven of the eight subjects. One subject developed a BG level of 65 mg/dl, which was signaled by the CGM trend analysis, and the MPC algorithm directed the discontinuance of the insulin infusion. The number of overnight hypoglycemic events was significantly reduced ( p = .011) with closed-loop control. Postprandial BG excursions were similar during closed-loop and open-loop control Conclusion: Model predictive closed-loop control of BG levels can be achieved overnight and following a standardized breakfast meal. This “artificial pancreas” controls BG levels as effectively as patient-directed open-loop control following a morning meal but is significantly superior to open-loop control in preventing overnight hypoglycemia.

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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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New horizons for insulin therapy with a pump: the artificial pancreas

The Journal of AMD ◽

10.36171/jamd21.24.2.2 ◽

2021 ◽

Vol 24 (2) ◽

pp. 86

Author(s):

Papa, G.

Keyword(s):

Type 1 Diabetes ◽

Insulin Therapy ◽

Basal Insulin ◽

Closed Loop ◽

Insulin Pump ◽

Artificial Pancreas ◽

Glucose Sensors ◽

Daily Injection ◽

Insulin Pumps

The monitoring and treatment of type 1 diabetes (T1D) are undergoing profound changes today. Notable steps include the improvement and widespread adoption of glucose sensors which are now extremely reliable and furthermore are used with insulin pumps in an integrated manner. Over the last 2 to 3 years these systems have evolved rapidly with the development and use of algorithms which permit the autonomous regulation of basal insulin. Correct control and administration of basal insulin is often the greatest stumbling block in multiple daily injection therapy as basal insulins cannot replicate the physiological rhythms of basal insulin secretion. Hypoglycemia is another critical point in standard insulin pen therapy as it does not permit dosage modulation in the same way as with an insulin pump. In this article we cover the fundamental steps in this revolution of insulin therapy which promises, in the not too distant future, the ultimate achievement of the artificial pancreas and thus the complete closure of the loop. All those working in diabetes care must be adequately trained and familiar with this technology as it should no longer be considered a niche treatment reserved for carefully selected patients and managed in only a few centers of excellence. In order to choose the best treatment, tailored to each individual patient’s needs, medical staff involved in the treatment of T1D require a thorough knowledge of standalone glucose sensors, insulin pumps and integrated systems with control algorithms.Once the critical issues (costs, psychological aspects, system management difficulties, alarm fatigue, etc.) still related to their use have been resolved, new Hybrid Closed Loop and Advanced Hybrid Closed Loop systems could become the new standard in the treatment of T1D. KEY WORDS type 1 Diabetes; insulin pump; decision-making algorithms; integrated system.

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