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

NCT04739124 | Completed

• 1 other identifier: 2020PPRC11
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diabetic patients

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

Other: Follow-up questionnaires; Other: Interviews

Caregivers

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

Other: Follow-up questionnaires

Interventions

Follow-up questionnaires 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)

Caregivers; Diabetic patients

Interviews OTHER

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

Diabetic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of diabetic patients and their caregivers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (2)

Hôpital Avicenne

Bobigny, 93009, France

Location

Hopital d'Instruction des Armées Bégin

Saint-Mandé, 94163, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: June 10, 2021
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (2)