Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump (DiabeloopWP3)

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

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Dexcom7; Device: Dexcom7

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25030
    • CHU Jean Minjoz
  • Caen, France, 14000
    • CHU de Caen
  • Corbeil Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien
  • Grenoble, France, 38043
    • University Hospital Grenoble
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nancy, France, 54500
    • Chu de Nancy
  • Toulouse, France, 31403
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Investigators: Study Chair: Guillaume CHARPENTIER, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; Principal Investigator: Bruno GUERCI, MD PHD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2011-A00726-35