Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump

Study Overview
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Brief Summary
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The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.

Official Title
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SEMI-CLOSED LOOP FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Dexcom7
* Device: Dexcom7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diabetes type 1 Treaty by external insulin pump Duration of diabetes than 2 years or c indosable peptide Practicing insulin functional (IF) or food plan sets Patient having a HbA1c < 10% Patient age over 18 years Patient having signed the form of collection of free consent and informed Patient affiliated with the social security Exclusion Criteria: Patients with diabetes type 2 Patient pregnant or likely to be All serious pathologies that can interfere with the study (in particular kidney or heart failure) Psychiatric pathologies incompatible with the study

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-3 sensor<br>patients will be equiped with 2 Dexcom sensors 3 days before hospitalization | Device: Dexcom7<br>* patients will wear 2 Dexcom sensors 3 days before hospitalization.<br>|
| Experimental: D-1 sensor<br>patients will be equiped with 2 Dexcom sensors one day before hospitalization | Device: Dexcom7<br>* patients will wear 2 Dexcom sensor one day before hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of data collected | The aim of the study is data collection of patient blood glucose and insulin in patients treated with continuous subcutaneous infusion insulin pump with a patchpump (JewelPUMPTM Debiotech) and equipped with two glucose sensors for the development of the control algorithm glucose. Blood sample are done every hour (achievement of glucose and insulin assays) ans every 15 minutes during 2 hours after meals. | Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours) |