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

• Sponsor: Direction Centrale du Service de Santé des Armées (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04739124
• Collaborator: (none)
• Enrollment: 142
• Locations: 2
• Anticipated Duration (Months): 10.7
• Patients Per Site: 71
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Other: Follow-up questionnaires; Other: Interviews

Study Design

• Study Type: Observational
• Anticipated Enrollment: 142 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
• Actual Study Start Date: Jun 10, 2021
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Avicenne	Bobigny		France	93009
2	Hopital d'Instruction des Armées Bégin	Saint Mande		France	94163

Sponsors and Collaborators

• Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Direction Centrale du Service de Santé des Armées
• ClinicalTrials.gov Identifier: NCT04739124
• Other Study ID Numbers: 2020PPRC11
• First Posted: Feb 4, 2021
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Sep 5, 2021