Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-03 @ 4:48 AM
Study NCT ID:
NCT05676593
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREEDIA
Brief 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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: