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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Dexcom7

• Registration Number: NCT01640223
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-24
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-3 sensor	Dexcom7	patients will be equiped with 2 Dexcom sensors 3 days before hospitalization
D-1 sensor	Dexcom7	patients will be equiped with 2 Dexcom sensors one day before hospitalization

Primary Outcome Measures

Name	Time	Method
Percentage of data collected	Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)	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.

Trial Locations

Locations (7)

CHU de Caen; 🇫🇷 Caen, France

CHU Toulouse; 🇫🇷 Toulouse, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil Essonnes, France

CHU Jean Minjoz; 🇫🇷 Besancon, France

University Hospital Grenoble; 🇫🇷 Grenoble, France

Chu Montpellier; 🇫🇷 Montpellier, France

CHU de Nancy; 🇫🇷 Nancy, France