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

NCT06098040 | Active Not Recruiting FDA Device

• 1 other identifier: DIAFLASH
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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

Type 2 Diabetes

Keywords

time in range; quality of life; bio feedback; flash glucose monitoring

Outcome Measures

Primary Outcomes (1)

• time in range

  difference in the means of time in range (TIR) registered at the weeks 23-24 phase through blinded device Free style Libre PRO-IQ, among the three groups and adjusted for baseline phase values.

  6 months

Secondary Outcomes (7)

• time in range

  3 months

• mindfulness

  3-6 months

• Body Mass Index (BMI,kg/m^2)

  6 months

• Body Composition

  6 months

• Physical activity

  6 months

Study Arms (3)

group 2 - FGM continuous

EXPERIMENTAL

Patients will be asked to wear the sensor FreeStyle Libre2 continuously

Device: flash glucose monitoring continuous

group 3 - FGM intermittent

EXPERIMENTAL

will be asked to wear the sensor FreeStyle Libre2 intermittently

Device: flash glucose monitoring intermittent

group 1- SMBG

ACTIVE COMPARATOR

Patients will be asked to test capillary blood glucose as recommended by subjects' usual provider

Diagnostic Test: capillary blood test

Interventions

flash glucose monitoring continuous DEVICE

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.

group 2 - FGM continuous

capillary blood test DIAGNOSTIC_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.

group 1- SMBG

flash glucose monitoring intermittent DEVICE

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.

group 3 - FGM intermittent

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 1:1
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, 00100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Silvia Manfrini, MD

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

• Rossella Tozzi, MD PhD

  Campus Bio-Medico University

  STUDY CHAIR

• Dario Tuccinardi, MD PhD

  Campus Bio-Medico University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and head of the endocrinology and diabetes unit

Model Details: three-armed parallel group

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 24, 2023
• Study Start: September 22, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: after the publication
• Access Criteria: IPD that underlie results in a publication on request

Locations

IT (1)