Using Freestyle Libre 2 to improve diabetes management in newly diagnosed patients
Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients
This study tests if using the Freestyle Libre 2 glucose monitor along with standard education helps people recently diagnosed with type 2 diabetes manage their blood sugar better over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05676593 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of continuous glucose monitoring (CGM) using Freestyle Libre 2 in conjunction with standard therapeutic patient education (TPE) for individuals recently diagnosed with type 2 diabetes. Participants will be randomly assigned to receive either standard TPE alone or TPE plus CGM for a duration of 28 days. The primary goal is to assess the impact of this combined approach on HbA1c levels at 3 months, while secondary objectives include evaluating weight changes, cardiovascular risk factors, and overall treatment satisfaction over a 6-month period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been recently diagnosed with type 2 diabetes and have an initial HbA1c between 7 and 8.5%.
Not a fit: Patients with severe physical or psychological health impairments or those who do not speak French may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glycemic control and better management of type 2 diabetes for newly diagnosed patients.
How similar studies have performed: Previous studies have shown positive outcomes with similar approaches using continuous glucose monitoring in diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier
- UHM Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: SULTAN Ariane, PU-PH
- Email: a-sultan@chu-montpellier.fr
- Phone: +33467338402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.