Status:
COMPLETED
Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
Lead Sponsor:
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2018
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT02287532
Start Date
February 1 2013
End Date
July 27 2018
Last Update
August 21 2018
Active Locations (108)
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1
Centre hospitalier du Pays d'Aix
Aix-en-Provence, France, 13616
2
Clinique Claude Bernard
Albi, France, 81030
3
CHI d'Alencon
Alençon, France, 61014
4
Centre hospitalier d'Ales
Alès, France, 30103