Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07423065

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionPre Diabetic, Obesity & Overweight

Full registry 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.

Treatments and study arms

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.

Primary outcomes

Change in Glycemic Variability Assessed by Coefficient of Variation from CGMEnd of each 12-week CGM phase

Change in glucose coefficient of variation (CV%), calculated from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%)

Postprandial Glucose Excursions Measured by CGMEnd of each 12-week CGM phase

Mean postprandial glucose excursion (PPGE) following habitual meals, derived from CGM data. Unit of Measure: mmol/L

Change in Mean Daily Energy IntakeEnd of each 12-week CGM phase

Change in mean daily caloric intake assessed using participant-completed food diaries. Unit of Measure: kcal/day

Study locations

3 locations were listed when this page was built. The first 40 are shown.

University of Primorska, Faculty of Health Sciences🌐 Izola, Slovenia
Zala Jenko Pražnikar, PhDContact
Ana Petelin, PhDContact
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia🌐 Koper, Slovenia
Ajda Urbas, MDContact
Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana🌐 Ljubljana, Slovenia
Mojca Jensterle Sever, PhDContact