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

NCT06098040 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-18

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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.

DIAGNOSTIC_TEST

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.

DEVICE

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.

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Silvia Manfrini, MD · Campus Bio-Medico University

  • Rossella Tozzi, MD PhD · Campus Bio-Medico University

  • Dario Tuccinardi, MD PhD · Campus Bio-Medico University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2025-06-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06098040 on ClinicalTrials.gov