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
University of Primorska
34 participants
Sep 1, 2026
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria9
- 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 Criteria11
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07423065