Feasibility Study of the JewelPump Version 3

Type 1 Diabetes Clinical Trial

Official title:

Feasibility Study of the JewelPump Version 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097316
• Other study ID #: 2013-A00792-43
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2013
• Last updated: October 24, 2014
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• JewelPump

• usual insulin pump

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Evry
France	CHU Marseille-Hôpital Nord	Marseille
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time spent below 70 mg / dl		up to 5 days in each treatment period	Yes
Other	Time spent above 180mg/dl;		up to 5 days in each treatment period	Yes
Primary	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.	up to 5 days of each treatment period	Yes
Secondary	Time spent in the strict glycemic area 80-140 mg / dl	Evaluate the superiority of JewelPump versus usual pump;	up to 5 days of each treatment period	Yes