Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment meos eportal use
Phase phase 3
Sponsor University Hospital, Grenoble
Start date January 2012
End date July 2014
Trial size 720 participants
Trial identifier NCT01447940, DCIC10 20

Summary

Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Placebo Comparator)
Patients will have conventional care with 2 standard visits (inclusion and 12 months) + HbA1c measure at 6 months. Patients won't use Meos ePortal
meos eportal use Telemedicine
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
(Experimental)
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
meos eportal use Telemedicine
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months

Primary Outcomes

Measure
HbA1c measured at 12 months in Meos ePoral group versus conventional care group. Non-inferiority level is defined at a 0.15% threshold for an expected HbA1c of 8.5% at 12 months
time frame: 12 months

Secondary Outcomes

Measure
HbA1c measured at 6 months in each group
time frame: 6 months
HbA1c measured at 12 months in each group
time frame: 12 months
HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)
time frame: 6 months
HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)
time frame: 12 months
Definition of failure: study withdraws or emergency hospitalization linked to diabetes or HbA1c increase of 0.5 % up to 12 months of follow up
time frame: 12 months
Annual cost of diabetes care from hospital and health insurance' points of view
time frame: 12 months
Quality of life at inclusion and 12 months, using the Diabetes Health Profile (DHP-1) scale and the Satisfaction items of the Diabetes Quality of Life (DQOL) questionnaire
time frame: 12 months
Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient with type 1 diabetes mellitus for ≥ 12 months or more - Age > 18 years old - Patient who is followed since 6 month into investigator hospital - Patient with available internet access at least once a week, and ability to understand MEOS website navigation - Patient using a compatible glucose meter (One touch ultra, Optium xceed, or BG star) Exclusion Criteria: - Patient with no easy and regular access to the Internet; - Patient found to be unfit for use of the telematic tools or e-mail tools - Patient with toxicomania, alcoholism or psychological troubles - Type 2 diabetic patients - Patient who does not need strict metabolic objectives - Pregnant or parturient women - Person with no freedom (prisoner)

Additional Information

Official title Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients
Principal investigator Pierre-Yves Benhamou, Pr
Description Meos is the name of the website (Telemedicine ePortal) tested in this trial ; it is used to share informations between diabetologist and type 1 diabetic patients.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.