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

University Hospital Center (CHU)

Status: Enrolling

Conditions: Type 2 Diabetes; Endocrinology

Treatments: Other: Therapeutic education; Device: Freestyle Libre 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05676593

RECHMPL22_0232

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

People living with diabete standard TPE

Active Comparator group

Description:

HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months

Treatment:

Other: Therapeutic education

People living with diabete standard TPE + FSL 28 days

Experimental group

Description:

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

Treatment:

Other: Therapeutic education

Device: Freestyle Libre 2