Feasibility Study of the JewelPump Version 3

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

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Device: usual insulin pump; Device: JewelPump

Study type: Interventional

Funder types: Other

Identifiers

NCT02097316

2013-A00792-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

JewelPump

Experimental group

Description:

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

Treatment:

Device: JewelPump

Device: usual insulin pump

Usual insulin pump

Active Comparator group

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.

Treatment:

Device: JewelPump

Device: usual insulin pump