Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

— FREEDIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676593
• Other study ID #: RECHMPL22_0232
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: December 3, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Montpellier
• Contact: SULTAN Ariane, PU-PH
• Phone: +33467338402
• Email: a-sultan[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 3, 2024
• Est. primary completion date: November 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocrinology
• Type 2 Diabetes

Intervention

Device:
• Freestyle Libre 2
The FSL will be placed on patient for 28 days to measure interstitial glucose

Other:
• Therapeutic education
Therapeutic education

Locations

Country	Name	City	State
France	UHM Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in glycated hemoglobine at 3 months	biological control of glycated hemoglobin in a laboratory	3 months
Secondary	Rate of change of the time in range, time above range and time below range	data of the freestyle libre	6 months
Secondary	Rate of change in glycated hemoglobin at 6 months	biological control	6 months
Secondary	Rate of change in weight in kg		In kg each 3,6 months
Secondary	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
Secondary	Rate of change arteriel pressure		In mmHg each 3,6 months
Secondary	Concentration of of LDL cholesterol		In g/L each 3,6 months
Secondary	Concentration of Triglyceride		In g/L each 3,6 months
Secondary	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
Secondary	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
Secondary	Eating behavior questionnaire	DEBQ-Dutch Eating Behaviour Questionnaire	33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months