Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin — TELEDIAB-2  

TYPE 2 DIABETES Clinical Trial

Official title: Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study

Status Completed

Clinical Trial Summary

TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

Clinical Trial Description

Secondary objectives :

1. - To compare the 2 methods of telemonitoring employed.

2. - To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.

3. - To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• TYPE 2 DIABETES

• NCT number: NCT00937703
• Study type: Interventional
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Completion date: May 2013