Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education

Study Overview
=================
Brief Summary
-----------------
Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.

Official Title
-----------------
Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education

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

Intervention / Treatment
-----------------
* Other: Follow-up questionnaires
* Other: Interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Have type 1 or type 2 diabetes (as included in the education program), Be of legal age (over 18 years old), Do not present legal protection measures due to incapacity (such as guardianship or guardianship). Be able to read and speak French (elementary school level) Be eligible for FSL prescription and authorize the sharing of your data in Libreview® Be affiliated to a social security scheme Have an email address or a phone allowing internet use Caregivers Be registered on the roll of his professional order Hold the certificate of 40 hours of training in therapeutic education. Practice therapeutic education on a regular basis Exclusion Criteria: Patients presenting contraindications to the use of Freestyle Libre® (known allergies to adhesive products, coagulation disorders, not treated with insulin therapy or with less than 3 insulin injections per day or continuously, not requiring glycemic monitoring or less than 3 times a day) Patient refusing to follow the education program, Minors, patients under administrative or judicial supervision) Pregnant women, Patients who cannot be contacted in an emergency, Persons in a position to give their consent but with an inability to read / write the French language. Patients who do not have an email address or a phone allowing internet use. Caregivers Failure to register with the professional order (except those of the Army Health Service who are exempt) Non-possession of the 40-hour therapeutic education training certificate. Not practicing FSL education

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients<br>Patients presenting type 1 or type 2 diabetes, eligible for the prescription of Freestyle Libre | Other: Follow-up questionnaires<br>* The patient normally follows the education program as usual but research specific data is collected: Biological sampling at the start and end of the education program (glycated hemoglobin). Retrieval of usage and glycemic balance data from the Libreview online platform (at one week, one month and three months of use) Iterative questionnaires allowing the study of factors of acceptance, appropriation and use (at the start of the study, at 4 weeks, at 12 weeks)<br>Other: Interviews<br>* Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.<br>|
| Caregivers<br>Caregiver caring for diabetic patients and practicing therapeutic education on a regular basis | Other: Follow-up questionnaires<br>* The patient normally follows the education program as usual but research specific data is collected: Biological sampling at the start and end of the education program (glycated hemoglobin). Retrieval of usage and glycemic balance data from the Libreview online platform (at one week, one month and three months of use) Iterative questionnaires allowing the study of factors of acceptance, appropriation and use (at the start of the study, at 4 weeks, at 12 weeks)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control | longitudinal multifactor analysis by structural equation modeling of the research model created specifically | 3 months |