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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Meos ePortal use


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional Care<br>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<br>* Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months<br>* Other names: ePortal;|
| Experimental: Meos ePortal use<br>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<br>* Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months<br>* Other names: ePortal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c measured at 6 months in each group |  | 6 months | 
| HbA1c measured at 12 months in each group |  | 12 months | 
| HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median) |  | 6 months | 
| HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median) |  | 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 |  | 12 months | 
| Annual cost of diabetes care from hospital and health insurance' points of view |  | 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 |  | 12 months | 
| Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Type 1 diabetes, economic cost of Type 1 diabetes, ePortal Meos