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Not Yet Recruiting NCT05676593

Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

Conditions: Endocrinology, Type 2 Diabetes

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: University Hospital, Montpellier

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 vsa 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

Eligibility Criteria

Inclusion Criteria:recently diagnosed diabete mellitus (<1 an) treated by non medical therapeutics and/or metformine> 18 years oldinitial glycated hemoglobin between 7 and 8.5%Exclusion Criteria:Person whose physical and/or psychological health is severely impairedPerson deprived of his rights, person under guardianship or curatorshipPerson deprived of liberty (by judicial or administrative decision)Person who does not speak the French languageAbsence of affiliation to/Not beneficiary of a Social Security schemeAbsence of written informed consent to participate in the studyUnable to understand the nature, purpose and methodology of the studyBariatric surgery planned within 6 months of inclusion

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05676593). StuddyBuddy aggregates publicly available trial information.