Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients (TELEDIAB-3)

December 8, 2014 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

720

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse-Normandie
      • Caen, Basse-Normandie, France, 14033
        • University Hospital of Caen (Hospital Côte de nacre)
    • Franche Comté
      • Besancon, Franche Comté, France, 25030
        • University Hospital of Besancon - Hospital Jean Minjoz
    • Ile de France
      • Corbeil Essonne, Ile de France, France, 91100
        • Hospital Sud Francilien
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Hospital University of Montpellier
    • Marne
      • Reims, Marne, France, 51110
        • University Hospital of Reims
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44093
        • University Hospital of Nantes
    • Rhône-Alpes
      • Grenoble, Rhône-Alpes, France, 38043
        • University Hospital, Department of Endocrinology
    • Rhônes-Alpes
      • Lyon, Rhônes-Alpes, France, 69310
        • University Hospital of Lyon (HCL Lyon sud)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Conventional Care
Patients will have conventional care with 2 standard visits (inclusion and 12 months) + HbA1c measure at 6 months. Patients won't use Meos ePortal
Device: Meos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Other Names:
  • Telemedicine
  • ePortal
Experimental: Meos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Device: Meos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Other Names:
  • Telemedicine
  • ePortal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c measured at 6 months in each group
Time Frame: 6 months
6 months
HbA1c measured at 12 months in each group
Time Frame: 12 months
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
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
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
12 months
Annual cost of diabetes care from hospital and health insurance' points of view
Time Frame: 12 months
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
12 months
Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Pierre-Yves Benhamou, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC10 20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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