NCT00629304

Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients

Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

• Status: Completed
• Phase: Phase 3
• 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-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care. Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

Detailed description

Secondary Objectives : 1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system 2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system 3. Satisfaction of patients and physicians towards the PDA-FIT system

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	placebo	Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
DEVICE	VISITS + PDA-FIT system	patients will have face to face visits at 3 and 6 months + PDA-FIT system
DEVICE	PDA-FIT System + telephone follow-up	patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-03-01
• Completion: 2009-08-01
• First posted: 2008-03-05
• Last updated: 2012-02-09

Locations

18 sites across 1 country: France