Feasibility Study of the JewelPump Version 3

October 24, 2014 updated by: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Evry, France, 91000
        • Centre Hospitalier Sud Francilien
      • Marseille, France, 13000
        • CHU Marseille-Hôpital Nord
      • Strasbourg, France, 67091
        • CHU Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JewelPump
JewelPump for the first treatment period followed by the usual pump for the second treatment period
Device: JewelPump
Device: usual insulin pump
Active Comparator: Usual insulin pump
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.
Device: JewelPump
Device: usual insulin pump

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in the strict glycemic area 80-140 mg / dl
Time Frame: up to 5 days of each treatment period
Evaluate the superiority of JewelPump versus usual pump;
up to 5 days of each treatment period

Other Outcome Measures

Outcome Measure
Time Frame
Time spent below 70 mg / dl
Time Frame: up to 5 days in each treatment period
up to 5 days in each treatment period
Time spent above 180mg/dl;
Time Frame: up to 5 days in each treatment period
up to 5 days in each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Sylvia FRANC, MD, Centre Hospitalier Sud Francilien
  • Principal Investigator: Nathalie JEANDIDIER, Pr., University Hospital, Strasbourg, France
  • Principal Investigator: Denis RACCAH, Pr., Centre Hospitalier Universitaire de Marseille
  • Study Chair: Guillaume CHARPENTIER, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00792-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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