Artificial Pancreas in Latin America

Study Overview
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Brief Summary
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The purpose of this study is to use closed-loop systems with the algorithms designed by the University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).

Detailed Description
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Aims: To test University of Virginia closed-loop algorithm with meal announcement for 36 hours at our facilities. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm without meal announcement to maintain glucose control for 2 periods of 12 hours In both cases, the adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time .

Official Title
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Pilot Study of Automatic Glycaemic Correction Systems (Closed-loop) in Patients With Type 1 Diabetes Mellitus With Continuous Subcutaneous Insulin Infusion

Conditions
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Diabetes

Intervention / Treatment
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* Device: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient have been diagnosed with T1DM at least two years ago and have been using an insulin pump and a CGM for at least 6 months prior to the trial first visit. Patient is >18 and <65 years. Patient has HbA1c > 6.5 % and < 10%. Woman in premenopausal age agrees to use contraceptive methods. Woman in premenopausal age has negative B-HCG in the tests performed in the trial. Patient is trained in carbohydrates counting. Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits. Exclusion Criteria: Patient has been hospitalized for diabetic ketoacidosis in the last 12 months. Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months. Patient has a history of coronary disease or cardiac failure. Patient with uncontrolled arterial hypertension. Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia. Patient has symptoms compatible with an active infectious disease. Patient has Cystic Fibrosis. Pregnant women, or women with the intention of getting pregnant; women breastfeeding. Patient has been hospitalized for psychiatric treatment in the last 6 months. Patient with a diagnosis of an adrenal disease. Patient has abnormal laboratory values for liver function: transaminase > 2x upper limit of normal. Patient has abnormal laboratory values for renal function: GFR < 60 ml/min/1.73m2 Patient has active gastroparesis. Patient is under oncological treatment. Patient has taken acetaminophen 72 hours previous to the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UVa and ITBA/UNLP algorithm arm<br>To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm | Device: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm<br>* The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System connectivity | Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time. | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical fail rate |  | 36 hours | 
| Percentage of time in glycaemia between 70-180 mg/dl |  | 36 hours | 
| Percentage of time in glycaemia between 181-250 mg/dl |  | 36 hours | 
| Percentage of time in hypoglycaemia defined as <70 mg/dl |  | 36 hours | 
| Percentage of time in hyperglycaemia defined as >180 mg/dl |  | 36 hours | 
| Number of all hypoglycaemic events (syntomatic and non syntomatic) |  | 36 hours | 
| Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial |  | 36 hours | 
| Meal composition's effect in the efficacy of the system to control glycaemia |  | 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, Artificial Pancreas, control System, Closed loop, T1DM, pump, algorithm, CGM