Clinical Research Directory
Browse clinical research sites, groups, and studies.
Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients
Sponsor: Campus Bio-Medico University
Summary
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.
Official title: Long-Term Feedback Effect of Flash Glucose Monitoring (Freestyle Libre2®) in Newly-Diagnosed Type 2 Diabetic Patients: a Randomized Monocentric Parallel-group Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2023-09-22
Completion Date
2025-09-30
Last Updated
2025-02-18
Healthy Volunteers
No
Conditions
Interventions
flash glucose monitoring continuous
Group 2 (FGM continuous): will be asked to wear the sensor FreeStyle Libre2 for the FGM with the following frequency fashion continuously for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider.
capillary blood test
Group 1 (SMBG): will be asked to test capillary blood glucose as recommended by subjects' usual provider for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider.
flash glucose monitoring intermittent
Group 3 (FGM intermittent): will be asked to wear the sensor FreeStyle Libre2 for the FGM with the following frequency fashion 1 week off/2 weeks on for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider.
Locations (1)
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Roma, Italy