Feasibility Study of the JewelPump Version 3

NCT ID: NCT02097316

Last Updated: 2014-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JewelPump

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

Group Type EXPERIMENTAL

JewelPump

Intervention Type DEVICE

usual insulin pump

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

JewelPump

Intervention Type DEVICE

usual insulin pump

Intervention Type DEVICE

Interventions

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JewelPump

Intervention Type DEVICE

usual insulin pump

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvia FRANC, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Nathalie JEANDIDIER, Pr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Denis RACCAH, Pr.

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Marseille

Guillaume CHARPENTIER, MD

Role: STUDY_CHAIR

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

Locations

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Centre Hospitalier Sud Francilien

Évry, , France

Site Status

CHU Marseille-Hôpital Nord

Marseille, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00792-43

Identifier Type: -

Identifier Source: org_study_id

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