NCT06098040Active, not recruiting
Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients
Long-Term Feedback Effect of Flash Glucose Monitoring (Freestyle Libre2®) in Newly-Diagnosed Type 2 Diabetic Patients: a Randomized Monocentric Parallel-group Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Feb 2025
Brief summary (registry, in English)
This clinical trial aims to evaluate the educational training of 12-weeks using flash glucose monitoring (FGM) FreeStyle Libre2 (FSL2; Abbott Diabetes Care Inc., Alameda, CA, USA) in newly- diagnosed T2D subjects who are treated with metformin in term of sustained improvement in glycemic variability (TIR) after the discontinuation of FGM compared to self-monitoring of blood glucose (SMBG). This clinical trial also aim to explore which frequency of sensor wear at the diagnosis is more effective in achieving a sustained improvement in TIR after the FGM discontinuation over time.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 4 Oct 2023
- Start date
- 22 Sept 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Campus Bio-Medico University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06098040
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 22 Sept 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- alcohol or drug abuse/dependency
- antidiabetic therapy other than metformin;
- high dose steroids;
- previous bariatric intervention or gastrectomy;
Other illness
- diagnosis of type 1 diabetes;
- severe illness (physical or mental health);
- cognitive impairment;
- uncorrected vision impairment;
- any allergy to the component of the device.
Lab values
- glycated hemoglobin exceeding 8.5%
- already using a continuous glucose monitor or flash glucose monitor;
Other
- pregnancy (on-going or planned during the study);
- hospitalized more than 2 times in past 12 months
- pace maker use
Who the study is looking for
- Diagnosed with type 2 diabetes mellitus ( according to the ADA Guidelines ) within the past 12 months
- Must be taking only metformin as glucose lowering treatments,
- Older than 18 years,
- Body Mass Index equal or greater than 25 Kg/m\^2,
- Must be able to provide written informed consent .
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.