Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients
NCT ID: NCT05676593
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-05-03
2024-12-03
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
* 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
PREVENTION
NONE
Study Groups
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People living with diabete standard TPE
HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months
Therapeutic education
Therapeutic education
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
Freestyle Libre 2
The FSL will be placed on patient for 28 days to measure interstitial glucose
Therapeutic education
Therapeutic education
Interventions
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Freestyle Libre 2
The FSL will be placed on patient for 28 days to measure interstitial glucose
Therapeutic education
Therapeutic education
Eligibility Criteria
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Inclusion Criteria
* \> 18 years old
* initial glycated hemoglobin between 7 and 8.5%
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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UHM Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECHMPL22_0232
Identifier Type: -
Identifier Source: org_study_id
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