Prognostic value of Continuous Glucose Monitoring metrics for microvascular and macrovascular complications in diabetes using Freestyle Libre® system records and SNDS French claims database linkage (FACULTY)

Study identification

• EU PAS number:
  EUPAS1000000188
• Study ID:
  1000000188
• Official title and acronym:
  Prognostic value of Continuous Glucose Monitoring metrics for microvascular and macrovascular complications in diabetes using Freestyle Libre® system records and SNDS French claims database linkage (FACULTY)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The FreeStyle Libre® (FSL) system is a glucose monitoring system that continuously measures glucose levels in the interstitial fluid of adults and children with type 1 (T1DM) or type 2 (T2DM) diabetes. In addition to the FSL system, LibreView (LV) is a secured platform storing glucose data and allowing the generation of individualized glucose report completing the glycemic picture [e.g., Time In Range (TIR), Glucose Variability and Hypoglycemic Exposure…]. In France, LV was part of the telemedicine program ETAPES (Expérimentations de Télémédecine pour l'Amélioration des Parcours En Santé) defined in Article 54 of the Social Security Financing Act for 2018 since May 2019 to experiment and assess the impact of telemonitoring for individuals with insulin treated diabetes. The application for registration was performed by the attending physician or by the physician who carries out the telemonitoring.; TIR or time in tight range (TITR) are potential alternatives to glycated hemoglobin (HbA1c), which is currently accepted as the gold-standard surrogate endpoint for diabetes clinical studies and management. A key step is now to understand if those new glucose metrics (e.g., TIR, TITR, GV and time in hypoglycaemia…) are linked to and can predict micro and macrovascular complications.; This study, to be performed using the SNDS (Système national des Données de Santé) French claims database, will assess firstly the relevance of the above diabetes monitoring metrics from CGMas predictors of micro and macrovascular complications, and secondly will investigate the added value of the ETAPES program to LV.; The objectives are to assess the prognostic value of CGM-derived diabetes monitoring metrics in determining the risk of microvascular and macrovascular complications, and to assess the clinical and economic benefits of the telemedicine program ETAPES for individuals using the LibreView diabetes telemonitoring platform with Freestyle Libre system.
• Study status:
  Planned

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 24/04/2022

Study start date

Planned: 31/03/2023

Data analysis start date

Planned: 30/06/2023

Date of interim report, if expected

Planned: 31/12/2024

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Abbott

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable