Diabetes Mellitus, Type 1
Conditions
Keywords
Telemedicine, Type 1 diabetes, economic cost of Type 1 diabetes, ePortal Meos
Brief 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.
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.
Interventions
DEVICEMeos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| 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 | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| HbA1c measured at 6 months in each group | 6 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 |
| 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 |
Countries
France
Outcome results
None listed