Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

University Hospital, Grenoble720 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

720

Conditions

Diabetes Mellitus, Type 1

Interventions

Meos ePortal useDEVICE

Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (8)

University Hospital, Department of Endocrinology

Grenoble, Auvergne-Rhône-Alpes, France

University Hospital of Caen (Hospital Côte de nacre)

Caen, Basse-Normandie, France

University Hospital of Besancon - Hospital Jean Minjoz

Besançon, Franche Comté, France

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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