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Clinical Trials in Italy / NCT06098040
Active, not recruiting Not applicable

Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients

NCT06098040 · tracked via the Priya Life Science Italy tracker
Sponsor
Campus Bio-Medico University
Phase
Not applicable
Started
2023-09-22
Last updated
2025-02-18

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

flash glucose monitoring continuouscapillary blood testflash glucose monitoring intermittent

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 . Exclusion Criteria: * diagnosis of type 1 diabetes; * glycated hemoglobin exceeding 8.5% * alcohol or drug abuse/dependency * antidiabetic therapy other than metformin; * pregnancy (on-going or planned during the study); * severe illness (physical or mental health); * cognitive impairment; * high dose steroids; * hospitalized more than 2 times in past 12 months * previous bariatric intervention or gastrectomy; * pace maker use * uncorrected vision impairment; * already using a continuous glucose monitor or flash glucose monitor; * any allergy to the component of the device.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Campus Bio-Medico Roma Roma

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06098040 on ClinicalTrials.gov ↗ ← All trials in Italy