Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients (FREEDIA)

June 11, 2026 updated by: University Hospital, Montpellier

Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients

Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.

The benefit of therapeutic education (TPE) has been clearly established on glycaemic control.

Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.

The investigators therefore propose a prospective randomised study in 2 arms :

  • a group of people living with diabetes receiving standard TPE vs
  • a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard TPE (Patient Therapeutic Education) vs standard TPE alone in newly diagnosed type 2 diabetics on HbA1c at 3 months.

The secondary objectives are to evaluate the effect of the TPE coupled with FSL vs TPE alone on :

  • HbA1c at 6 months (assessment of persistence or not of a remote effect)
  • weight change at 3 and 6 months
  • other cardiovascular risk factors : variation in blood pressure, lipid profil at 3 and 6 months
  • eating behaviour/ eating habits at 3 and 6 months
  • treatment satisfaction, anxiety and quality of life scores

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • UHM Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • recently diagnosed diabete mellitus (<1 an) treated by non medical therapeutics and/or metformine
  • > 18 years old
  • initial glycated hemoglobin between 7 and 8.5%

Exclusion Criteria:

  • Person whose physical and/or psychological health is severely impaired
  • Person deprived of his rights, person under guardianship or curatorship
  • Person deprived of liberty (by judicial or administrative decision)
  • Person who does not speak the French language
  • Absence of affiliation to/Not beneficiary of a Social Security scheme
  • Absence of written informed consent to participate in the study
  • Unable to understand the nature, purpose and methodology of the study
  • Bariatric surgery planned within 6 months of inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: People living with diabete standard TPE
HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months
Other: Therapeutic education
Therapeutic education
Experimental: People living with diabete standard TPE + FSL 28 days

Continuous mesure of glucose (FSL2) during 28 days at enrollment Therapeutic education HBA1c at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months

Auto questionnary on Aviitam plateform at 3 and 6 months
Other: Therapeutic education
Therapeutic education
Device: Freestyle Libre 2
The FSL will be placed on patient for 28 days to measure interstitial glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of change in glycated hemoglobine at 3 months
Time Frame: 3 months
biological control of glycated hemoglobin in a laboratory
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life questionnary
Time Frame: Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months
EQVOD - Scale of Quality of Life, Obesity and Dietetics
Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months
Quality of Life questionnary
Time Frame: From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months
EQ-5D - EuroQoL-5D
From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months
Rate of change of the time in range, time above range and time below range
Time Frame: 6 months
data of the freestyle libre
6 months
Rate of change in glycated hemoglobin at 6 months
Time Frame: 6 months
biological control
6 months
Rate of change in weight in kg
Time Frame: In kg each 3,6 months
In kg each 3,6 months
Rate of change arteriel pressure
Time Frame: In mmHg each 3,6 months
In mmHg each 3,6 months
Concentration of of LDL cholesterol
Time Frame: In g/L each 3,6 months
In g/L each 3,6 months
Concentration of Triglyceride
Time Frame: In g/L each 3,6 months
In g/L each 3,6 months
Anxiety and depression scale questionnary
Time Frame: 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months
HAD - Hospital Anxiety and Depression scale
14 questions (high score depression, anxiety - low score good health) performed at 3,6 months
Eating behavior questionnaire
Time Frame: 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months
DEBQ-Dutch Eating Behaviour Questionnaire
33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Actual)

June 25, 2025

Study Completion (Actual)

June 25, 2025

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0232
  • 2022-A01899-34 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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