Diabetes
Conditions
Brief summary
The aim of the TELESAGE study is to demonstrate 1. the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen. 2. the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen. The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system. The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)
Interventions
DEVICEDIABEO software
DIABEO is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system. DIABEO software could be combined with remote paramedical monitoring of data (telemonitoring)
Sponsors
Sanofi
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetic patients * Performing auto-glycaemic control (at least 2 glycemias a day) * Treated with insulin by a basal-bolus regimen for at least 1 year and using the same method of administration for at least 3 months (insulin pen or pump) * Who have an Apple® or Androïde® Smartphone compatible, or intend to acquire one before their participation in the study * Whose HbA1c dating of less 1 month and more than 3 months is ≥ 8% * Who are able to understand and follow the study protocol * Who have given their signed consent to take part in the study * Subject affiliated to the French National Health Insurance funds or benefiting from such insurance
Exclusion criteria
* Age \< 18 years old * Patients who have used the DIABEO system within 6 months before inclusion * Participation in a clinical study within 6 months, except for the Meos (or télédiab 3) study after a participation period of 6 months * Patients who are pregnant or who wish to become pregnant during the study. * Patients treated with human insulin A patient pre-screening register will be set up in each centre to establish the reasons for DM1/DM2 patients treated with a basal-bolus insulin regimen who are not taking part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy data: change in HbA1c, measured at 1 year minus the value baseline | one year |
Countries
France
Outcome results
None listed