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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dexcom7
Dexcom7
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Jean Minjoz
  • CHU de Caen
  • Centre Hospitalier Sud Francilien
  • University Hospital Grenoble
  • Chu Montpellier
  • CHU de Nancy
  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

D-3 sensor

D-1 sensor

Arm Description

patients will be equiped with 2 Dexcom sensors 3 days before hospitalization

patients will be equiped with 2 Dexcom sensors one day before hospitalization

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2012
Last Updated
October 24, 2014
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT01640223
Brief Title
Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-3 sensor
Arm Type
Experimental
Arm Description
patients will be equiped with 2 Dexcom sensors 3 days before hospitalization
Arm Title
D-1 sensor
Arm Type
Experimental
Arm Description
patients will be equiped with 2 Dexcom sensors one day before hospitalization
Intervention Type
Device
Intervention Name(s)
Dexcom7
Intervention Description
patients will wear 2 Dexcom sensors 3 days before hospitalization.
Intervention Type
Device
Intervention Name(s)
Dexcom7
Intervention Description
patients will wear 2 Dexcom sensor one day before hospitalization
Primary Outcome Measure Information:
Title
Percentage of data collected
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume CHARPENTIER, MD
Organizational Affiliation
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruno GUERCI, MD PHD
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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