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

NCT00629304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-02-09

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Pierre Yves BENHAMOU, MD PHD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-03-31
Completion
2009-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629304 on ClinicalTrials.gov