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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Follow-up questionnaires; Other: Interviews

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93009
    • Hopital Avicenne
  • Saint Mande, France, 94163
    • Hôpital d'Instruction des Armées Bégin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic patients; Patients presenting type 1 or type 2 diabetes, eligible for the prescription of Freestyle Libre	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); Other: Interviews; 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2020PPRC11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No