Comparing artificial pancreas controlled by hybrid "closed-loop" machine learning (ML) trained algorithm to multi-daily injection (MDI), insulin pump without CGM and "sensor assisted" insulin pump therapies for Diabetes Type 1 (DT1) treatment

Diabetes mellitus type 1 is a chronic metabolic disorder, and its main characteristic is Hyperglycemia. It usually occurs in the early years because of the absolute or relative absence of the active insulin that is caused by the autoimmune disease of the β cells of the pancreas. Despite the numerous researches and efforts of the scientists, the therapy for Diabetes type 1 is based on the substitution of insulin. Even though the principles of the therapy have not changed so much, still some important changes have occurred in the production and usage of insulin. Lately, the insulin pumps are more frequent in the therapy for Diabetes type 1. The functioning of the pump is based on the continuing delivery of insulin in a small dose (“the basal dose”), that keeps the level of glycemia in the blood constant. The increase of glycemia during the meal is reduced with the additional dose of insulin (“the bolus dose”). The use of the insulin pumps and the continuing glucose sensors has provided an easier and more efficient monitoring of the diabetes, a better metabolic control and a better life quality for the patient and his/her family.This work presents the way of automatic regulation of the basal dose of insulin through the synthesis of the functions of the insulin pump and the continuing glucose sensor. The aim is to give a contribution to the development of the controlling algorithm on the insulin pump for the automatic regulation of the glucose concentration in the blood. This could be a step further which is closer to the delivery of the dose of insulin that is really needed for the basic needs of the organism, and a significant contribution is given to the development of the artificial pancreas.

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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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Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial

Yearbook of Paediatric Endocrinology ◽

10.1530/ey.16.10.3 ◽

2019 ◽

Author(s):

Mueller-Godeffroy E ◽

Vonthein R ◽

Ludwig-Seibold C ◽

Heidtmann B ◽

Boettcher C ◽

...

Keyword(s):

Insulin Pump ◽

Controlled Trial ◽

Diabetes Type ◽

Insulin Pump Therapy ◽

Diabetes Type 1 ◽

Pump Therapy ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Psychosocial Benefits

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Underestimation of actual insulin needs among people with diabetes type 1 on insulin pump therapy

Clinical Nutrition ESPEN ◽

10.1016/j.clnesp.2016.03.033 ◽

2016 ◽

Vol 13 ◽

pp. e62

Author(s):

Parthena Giannoulaki ◽

Iro Gounitsioti ◽

Fotis Iliadis ◽

Apostolos Hatzitolios ◽

Aggelos Pappas ◽

...

Keyword(s):

Insulin Pump ◽

Diabetes Type ◽

Insulin Pump Therapy ◽

Diabetes Type 1 ◽

Pump Therapy

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

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgaa562 ◽

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 <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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Bolus wizard use has a beneficial effect in glycemic control among people with diabetes type 1 on insulin pump therapy

Clinical Nutrition ESPEN ◽

10.1016/j.clnesp.2016.03.034 ◽

2016 ◽

Vol 13 ◽

pp. e62-e63 ◽

Cited By ~ 3

Author(s):

Parthena Giannoulaki ◽

Iro Gounitsioti ◽

Fotios Iliadis ◽

Apostolos Hatzitolios ◽

Aggelos Pappas ◽

...

Keyword(s):

Glycemic Control ◽

Beneficial Effect ◽

Insulin Pump ◽

Diabetes Type ◽

Insulin Pump Therapy ◽

Diabetes Type 1 ◽

Pump Therapy

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A Novel Artificial Pancreas: Energy Efficient Valveless Piezoelectric Actuated Closed-Loop Insulin Pump for T1DM

Applied Sciences ◽

10.3390/app10155294 ◽

2020 ◽

Vol 10 (15) ◽

pp. 5294

Author(s):

Alp Kaçar ◽

Mehmet Bülent Özer ◽

Yiğit Taşcıoğlu

Keyword(s):

Energy Efficient ◽

Closed Loop ◽

Insulin Pump ◽

Artificial Pancreas ◽

Pid Controllers ◽

Order Model ◽

Piezoelectric Pump ◽

Reduced Order ◽

Different Types

The objective of this work is to develop a closed-loop controlled insulin pump to keep the blood glucose level of Type 1 diabetes mellitus (T1DM) patients in the desired range. In contrast to the existing artificial pancreas systems with syringe pumps, an energy-efficient, valveless piezoelectric pump is designed and simulated with different types of controllers and glucose-insulin models. COMSOL Multiphysics is used for piezoelectric-fluid-structural coupled 3D finite element simulations of the pump. Then, a reduced-order model (ROM) is simulated in MATLAB/Simulink together with optimal and proportional-integral-derivative (PID) controllers and glucose–insulin models of Ackerman, Bergman, and Sorensen. Divergence angle, nozzle/diffuser diameters, lengths, chamber height, excitation voltage, and frequency are optimized with dimensional constraints to achieve a high net flow rate and low power consumption. A prototype is manufactured and experimented with different excitation frequencies. It is shown that the proposed system successfully controls the delivered insulin for all three glucose–insulin models.

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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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