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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Meos ePortal use

Study type: Interventional

Funder types: Other

Identifiers

NCT01447940

DCIC10 20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups, including a placebo group

Conventional Care

Placebo Comparator group

Description:

Patients will have conventional care with 2 standard visits (inclusion and 12 months) + HbA1c measure at 6 months. Patients won't use Meos ePortal

Treatment:

Device: Meos ePortal use

Meos ePortal use

Experimental group

Description:

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

Treatment:

Device: Meos ePortal use