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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Primorska

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18-70 years.

BMI ≥ 27 kg/m² (overweight or obese).

Stable body weight (±3 kg) in the last 3 months.

No current use of antidiabetic or weight-loss medications.

Disqualifiers

Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%).

Any antidiabetic medication (insulin, metformin, GLP-1RA, SGLT2i, etc.), or anti-obesity pharmacotherapy.

Pregnancy, breastfeeding, or planned pregnancy during the study period.

Severe chronic disease that could influence glucose metabolism or study participation (e.g., chronic liver disease, renal failure, active malignancy).

Trial design

Treatments tested in this trial

  • Continuous Glucose Monitoring (CGM)

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Primorska

Lead sponsor

Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia

Collaborator

University Medical Centre Ljubljana

Collaborator