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Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study Patients

NCT00758082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2010-03-11

No results posted yet for this study

Summary

TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

paper support

Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.

DEVICE

PDA-phone + telemonitoring

Patients will received PDA-phone + a telephone follow up + standard visit at 3 months

Sponsors & Collaborators

  • AGIR à Dom

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Pierre Y Benhamou, PhD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • France

Study Locations

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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 NCT00758082 on ClinicalTrials.gov