Diabetes
Conditions
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.
Interventions
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)
OTHERInterviews
Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.
Sponsors
Direction Centrale du Service de Santé des Armées
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control | 3 months | longitudinal multifactor analysis by structural equation modeling of the research model created specifically |
Countries
France
Outcome results
None listed