The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity

Sponsor
University of Primorska
Study ID
NCT07423065
Status
Recruiting
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Conditions

  • Obesity & Overweight
  • Pre Diabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitoring (CGM) — DEVICE
    Use of a continuous glucose monitoring system to measure interstitial glucose levels. During the open CGM phase, participants have real-time access to glucose data; during the blinded CGM phase, glucose data are masked from participants.

Study Details

This randomized, crossover interventional study evaluates the effects of real-time (open) versus blinded continuous glucose monitoring (CGM) on glycemic variability, lifestyle behaviors, and metabolic outcomes in adults with prediabetes and overweight or obesity (BMI ≥ 27 kg/m²). Thirty participants will undergo both open and blinded CGM phases, separated by a washout period. The study aims to assess whether access to real-time glucose data promotes behavioral change and improves metabolic health compared with blinded CGM use.

Key Dates

First listed
Feb 20, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Open CGM
  • Experimental: Blinded CGM

Primary Outcome Measure

Change in Glycemic Variability Assessed by Coefficient of Variation from CGM [ Time Frame: End of each 12-week CGM phase ]

Central Contacts

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