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

Type 1 Diabetes Clinical Trial

— DiabeloopWP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640223
• Other study ID #: 2011-A00726-35
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: October 24, 2014
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2014
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• Dexcom7
patients will wear 2 Dexcom sensors 3 days before hospitalization.
• Dexcom7
patients will wear 2 Dexcom sensor one day before hospitalization

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besancon
France	CHU de Caen	Caen
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes
France	University Hospital Grenoble	Grenoble
France	Chu Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No