NCT00937703

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• TYPE 2 DIABETES

Interventions

Type	Name	Description
DEVICE	placebo	paper support for glycaemia face to face visit at T4mounths
DEVICE	IVS	patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation. Face to face visit at T4mounths plus telephone visits each 2 weeks.
DEVICE	PDAphone	Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-07-13
• Last updated: 2013-12-13

Locations

28 sites across 1 country: France