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OpenTrials
Completed

NCT Number: NCT04739124

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Avicenne, Bobigny, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Interviews

Other

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

Primary outcomes

  1. Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control

    Time frame: 3 months

    longitudinal multifactor analysis by structural equation modeling of the research model created specifically

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: APPRO-FSL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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