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

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: Recruiting
• Conditions: Type 2 Diabetes; Endocrinology
• Intervention / Treatment: Other: Therapeutic education; Device: Freestyle Libre 2

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 (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SULTAN Ariane, PU-PH; Phone Number: +33467338402; Email: a-sultan@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34090
    • Recruiting
    • UHM Montpellier
    • Contact: Ariane SULTAN, PI; Phone Number: +33 04 67 33 84 02; Email: a-sultan@chu-montpellier.fr

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	biological control of glycated hemoglobin in a laboratory	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life questionnary	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	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	data of the freestyle libre	6 months
Rate of change in glycated hemoglobin at 6 months	biological control	6 months
Rate of change in weight in kg		In kg each 3,6 months
Rate of change arteriel pressure		In mmHg each 3,6 months
Concentration of of LDL cholesterol		In g/L each 3,6 months
Concentration of Triglyceride		In g/L each 3,6 months
Anxiety and depression scale questionnary	HAD - Hospital Anxiety and Depression scale	14 questions (high score depression, anxiety - low score good health) performed at 3,6 months
Eating behavior questionnaire	DEBQ-Dutch Eating Behaviour Questionnaire	33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): November 3, 2024
• Study Completion (Estimated): December 3, 2024

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): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Glucose; Sensor; Therapeutic education; Diabete
• Other Study ID Numbers: RECHMPL22_0232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No