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Feasibility Study of the JewelPump Version 3

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
JewelPump
usual insulin pump
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 focused on measuring Glycemic control, JewelPump accuracy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients type 1 diabetics treated by external insulin pump;
  • Patients with HbA1c < 8.5%
  • Patients who signed consent

Exclusion Criteria:

  • Patients type 2 diabetics
  • Patients who have all serious diseases that could interfere with the study

Sites / Locations

  • Centre Hospitalier Sud Francilien
  • CHU Marseille-Hôpital Nord
  • CHU Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JewelPump

Usual insulin pump

Arm Description

JewelPump for the first treatment period followed by the usual pump for the second treatment period

Patients in the arm 2, will have the usual insulin pump for the first treatment period, followed with the second period which they will have the JewelPump.

Outcomes

Primary Outcome Measures

Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4
Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.

Secondary Outcome Measures

Time spent in the strict glycemic area 80-140 mg / dl
Evaluate the superiority of JewelPump versus usual pump;

Full Information

First Posted
September 26, 2013
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
NCT02097316
Brief Title
Feasibility Study of the JewelPump Version 3
Official Title
Feasibility Study of the JewelPump Version 3
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (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 study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.
Detailed Description
The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Glycemic control, JewelPump accuracy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JewelPump
Arm Type
Experimental
Arm Description
JewelPump for the first treatment period followed by the usual pump for the second treatment period
Arm Title
Usual insulin pump
Arm Type
Active Comparator
Arm Description
Patients in the arm 2, will have the usual insulin pump for the first treatment period, followed with the second period which they will have the JewelPump.
Intervention Type
Device
Intervention Name(s)
JewelPump
Intervention Type
Device
Intervention Name(s)
usual insulin pump
Primary Outcome Measure Information:
Title
Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4
Description
Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.
Time Frame
up to 5 days of each treatment period
Secondary Outcome Measure Information:
Title
Time spent in the strict glycemic area 80-140 mg / dl
Description
Evaluate the superiority of JewelPump versus usual pump;
Time Frame
up to 5 days of each treatment period
Other Pre-specified Outcome Measures:
Title
Time spent below 70 mg / dl
Time Frame
up to 5 days in each treatment period
Title
Time spent above 180mg/dl;
Time Frame
up to 5 days in each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients type 1 diabetics treated by external insulin pump; Patients with HbA1c < 8.5% Patients who signed consent Exclusion Criteria: Patients type 2 diabetics Patients who have all serious diseases that could interfere with the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia FRANC, MD
Organizational Affiliation
Centre Hospitalier Sud Francilien
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathalie JEANDIDIER, Pr.
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denis RACCAH, Pr.
Organizational Affiliation
Centre Hospitalier Universitaire de Marseille
Official's Role
Principal Investigator
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
Facility Information:
Facility Name
Centre Hospitalier Sud Francilien
City
Evry
ZIP/Postal Code
91000
Country
France
Facility Name
CHU Marseille-Hôpital Nord
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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Feasibility Study of the JewelPump Version 3

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