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

NCT00937703 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-12-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Guillaume CHARPENTIER, MD · Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

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 NCT00937703 on ClinicalTrials.gov