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

Sponsor: University of Primorska • ClinicalTrials.gov ID: NCT07423065

Registry updated: 2026-10-22

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Description

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.

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.

Eligibility criteria

Inclusion Criteria: * Adults aged 18-70 years. * BMI ≥ 27 kg/m² (overweight or obese). * Prediabetes, confirmed by: Impaired fasting glucose (IFG: 5.6-6.9 mmol/L), and/or Impaired glucose tolerance (IGT: 2-hour OGTT glucose 7.8-11.0 mmol/L). * Stable body weight (±3 kg) in the last 3 months. * No current use of antidiabetic or weight-loss medications. * Willingness and ability to wear a CGM device as instructed. * Capacity to provide written informed consent. * Recruitment from the Diabetes Outpatient Clinic, Community Health Center Koper (identified and invited from the clinic's database). Exclusion Criteria: * Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%). * Current or recent (within 3 months) use of: * 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). * Endocrine disorders affecting metabolism (e.g., untreated thyroid disease, Cushing's syndrome). * Severe psychiatric illness or cognitive impairment limiting adherence or comprehension. * Use of medications known to affect glucose metabolism (e.g., corticosteroids, atypical antipsychotics). * Implanted electronic medical devices (e.g., pacemaker, defibrillator) that may interfere with CGM function. * Known allergy or skin reaction to CGM adhesives or device materials. * Participation in another interventional study within the previous 3 months.

Conditions

Pre Diabetic Obesity & Overweight

Locations

University of Primorska, Faculty of Health Sciences — Izola, Slovenia
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia — Koper, Slovenia
Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana — Ljubljana, Slovenia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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