Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen

Study Overview
=================
Brief Summary
-----------------
The aim of the TELESAGE study is to demonstrate 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. 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)

Official Title
-----------------
Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: DIABEO software


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIABEO software alone<br>Patient will have an introductory training session in the use of DIABEO by the investigating physician an will return for an on site consultation at 6 mounths (optional), 12 mounths and 24 mounths | Device: DIABEO software<br>* 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)<br>|
| Experimental: DIABEO+paramedical telemonitoring<br>Patient will have an on site introductory training session in the use of DIABEO, by his/her telemedicine nurse from his/her region. The nurse will then follow up the patient according to a delegated tasks protocol written by the investigating physician with the nurse. Patient will be asked to return to see the investigator at 6 mounths (optional), 12 mounths and 24 mounths | Device: DIABEO software<br>* 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)<br>|
| No Intervention: Usual Follow up<br>Patient will continue his/her usual follow up and return to see the investigator at 6 mounths (optional) and at the one year end of follow up for the study | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy data: change in HbA1c, measured at 1 year minus the value baseline |  | one year |