TerminatedNot Applicable

Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

Stopped: Abbott has discontinued marketing of the medical device under investigation. FREESTYLE LIBRE 2 has been replaced by FREESTYLE LIBRE 2+, whose characteristics have been slightly modified.

France27 participantsStarted 2023-05-03

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether the FreeStyle Libre 2 sensor is still a safe or useful option for managing my type 2 diabetes?
2Since the trial was measuring changes in HbA1c over just 3 months, is that enough time to know whether continuous glucose monitoring with FreeStyle Libre 2 actually makes a meaningful difference for someone newly diagnosed like me?
3Given that this study was terminated, is there other completed research on FreeStyle Libre 2 in recently diagnosed type 2 diabetes patients that you'd feel more confident recommending to guide my care?
4Would you suggest I try standard blood glucose monitoring first before considering a device like FreeStyle Libre 2, especially since this trial didn't finish collecting its results?
5Are there any currently active trials or established clinical guidelines on using continuous glucose monitors in early-stage type 2 diabetes that might be a better fit for my situation right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of change in glycated hemoglobine at 3 months

Timeframe: 3 months

Trial details

NCT IDNCT05676593

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-25

View on ClinicalTrials.gov More Endocrinology trials