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
Sponsors and collaborators
University of Primorska
Lead sponsor
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
Collaborator
University Medical Centre Ljubljana
Collaborator