Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Campus Bio-Medico University

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ...

Detailed Description

Diabetes self-management represents the cornerstone of successful and cost-effective diabetes care, reducing the occurrence of complications, hospital admissions and readmission as well as estimated l...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2025

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT06098040

Start Date

September 22 2023

End Date

September 30 2025

Last Update

February 18 2025

Active Locations (1)

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Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, Italy, 00100