NCT07423065

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

The Impact of Continuous Glucose Monitoring on Behavioral Change, Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity - a Randomized Crossover Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Primorska · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prediabetes and obesity are major contributors to the development of type 2 diabetes and its complications. Early intervention focused on glycemic control and lifestyle modification is essential to prevent disease progression. Continuous glucose monitoring (CGM) provides real-time insight into glucose dynamics and may support behavioral change; however, evidence is limited on how access to glucose data influences sustained lifestyle modification and metabolic outcomes in individuals with prediabetes. The primary objectives are to assess the impact of real-time (open) versus blinded CGM on (1) glycemic variability using sensitive dynamic metrics, and (2) behavioral changes, including dietary habits and physical activity, in adults with prediabetes and overweight or obesity. Secondary objectives include evaluating the effects of CGM on anthropometric and metabolic parameters, biochemical and physiological markers of metabolic control, participant experience and acceptability of CGM, sustainability of lifestyle changes, and associations between glycemic variability and cardiometabolic risk reduction. This prospective, randomized, open-label, blinded crossover interventional study will evaluate the effects of CGM on behavior, glycemic variability, and weight loss in adults with prediabetes and obesity (BMI ≥ 27 kg/m²). Thirty participants will be recruited from the Diabetes Outpatient Clinic of the Community Health Center Koper. After screening and a 10-day blinded CGM run-in period, participants will be randomized (1:1) to one of two sequences: (A) open CGM for 12 weeks followed by a 30-day washout and 12 weeks of blinded CGM, or (B) blinded CGM for 12 weeks followed by washout and 12 weeks of open CGM. Participants will attend baseline and follow-up visits for anthropometric, biochemical, and behavioral assessments during each study phase.

Conditions

• Pre Diabetic
• Obesity & Overweight

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring (CGM)	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2026-02-20
• Last updated: 2026-04-03

Locations

3 sites across 1 country: Slovenia