NCT05676593

Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Endocrinology
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Freestyle Libre 2	The FSL will be placed on patient for 28 days to measure interstitial glucose
OTHER	Therapeutic education	Therapeutic education

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-11-03
• Completion: 2024-12-03
• First posted: 2023-01-09
• Last updated: 2023-11-07

Locations

1 site across 1 country: France