Status:
COMPLETED
Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04739124
Start Date
June 10 2021
End Date
September 6 2023
Last Update
September 21 2023
Active Locations (2)
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1
Hôpital Avicenne
Bobigny, France, 93009
2
Hopital d'Instruction des Armées Bégin
Saint-Mandé, France, 94163