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

NCT ID: NCT04739124

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2023-09-06

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.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic patients

Patients presenting type 1 or type 2 diabetes, eligible for the prescription of Freestyle Libre

Follow-up questionnaires

Intervention Type: OTHER

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

Intervention Type: OTHER

Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.

Caregivers

Caregiver caring for diabetic patients and practicing therapeutic education on a regular basis

Follow-up questionnaires

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Interviews

Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Avicenne

Bobigny, , France

Hopital d'Instruction des Armées Bégin

Saint-Mandé, , France

Countries

France

Other Identifiers

2020PPRC11

Identifier Type: -

Identifier Source: org_study_id