NCT04739124

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-10
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2021-02-04
• Last updated: 2023-09-21

Locations

2 sites across 1 country: France