Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

Study Overview
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Brief Summary
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To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy: at meals, with CHO roughly assessed by the patient. during and after physical activity sessions qualified as moderate by the patient. Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.

Detailed Description
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The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.

Official Title
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Diabeloop WP6-1 : Validation of the Artificial Pancreas Diabeloop Algorithm in the Hospital

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Insulin, Asp(B28)-


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient type 1 diabetic for at least one year Patient treated by external insulin pump for at least 6 months Patients with HbA1c <9% Patient affiliated with Social Security. Patient able to perform two tests of physical activity of 30 minutes (one event in each treatment period); aged at least 18 years Patient; Patient who signed consent Exclusion Criteria: All serious disease that could interfere with the study BMI > 30 kg/m2 insulin requirement > 2 U/kg/day Patient benefiting from a measure of legal protection; Pregnant or likely to be women.

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: unsual treatment<br>The patient will have his usual treatment in this arm | |
| Experimental: The Diabeloop algorithm<br>In this arm, the insulin Asp(B28) dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor. | Drug: Insulin, Asp(B28)-<br>* the insulin dose is calculated by the Diabeloop algorithm and then administered to the patient<br>* Other names: NovoRapid insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in blood glucose range [70-180 mg/dl] | comparing the time spent in [70-180 mg/dl] with usual algorithm vs Diabeloop algorithm. | up to 24 hours after each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent Blood Glucose range [80-140 mg/dl] | Comparing the time spent in range [80-140 mg/dl] with usual algorithm vs Diabeloop algorithm | 24 hours after each treatment period | 
| time spent below 70 mg/dl and above 180 mg/dl |  | up to 24 hours after each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial pancreas, Glycemic control algorithm, closed loop