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Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education (APPRO-FSL)

D

Direction Centrale du Service de Santé des Armées

Status

Completed

Conditions

Diabetes

Treatments

Other: Interviews
Other: Follow-up questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT04739124
2020PPRC11

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Diabetic patients
Description:
Patients presenting type 1 or type 2 diabetes, eligible for the prescription of Freestyle Libre
Treatment:
Other: Follow-up questionnaires
Other: Interviews
Caregivers
Description:
Caregiver caring for diabetic patients and practicing therapeutic education on a regular basis
Treatment:
Other: Follow-up questionnaires

Trial contacts and locations

2

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Central trial contact

Lyse Bordier, MD,PhD; Julien Bouix, MSc

Data sourced from clinicaltrials.gov

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