Clinical trial NCT04739124: Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
Official title: Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of diabetic patients and their caregivers.

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.


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

Primary outcomes:
measure: Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Saint Mande
country: France
facility: Hopital d'Instruction des Armées Bégin
Study officials:
References: