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

Diabetes Clinical Trial

— APPRO-FSL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739124
• Other study ID #: 2020PPRC11
• Status: Completed
• Start date: June 10, 2021
• Est. completion date: September 6, 2023

Study information

• Verified date: September 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Follow-up questionnaires
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)
• Interviews
Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Hopital d'Instruction des Armées Bégin	Saint Mande

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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