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

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Chu Montpellier

Montpellier, Montpellier, France

CHU Toulouse

Toulouse, Toulouse, France

CHU Jean Minjoz

Besançon, France

CHU de Caen

Caen, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

University Hospital Grenoble

Grenoble, France

CHU de Nancy

Nancy, France

Outcomes

Primary Outcomes

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.

Time frame: Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)