Actively Recruiting
The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity
Led by University of Primorska · Updated on 2026-04-28
34
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Primorska
Lead Sponsor
D
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-70 years
- Body mass index (BMI) of 27 kg/m6 or higher
- Confirmed prediabetes by impaired fasting glucose (5.6-6.9 mmol/L) and/or impaired glucose tolerance (2-hour OGTT glucose 7.8-11.0 mmol/L)
- Stable body weight within �b13 kg in the last 3 months
- No current use of antidiabetic or weight-loss medications
- Willing and able to wear a continuous glucose monitoring device as instructed
- Able to provide written informed consent
- Recruitment from the Diabetes Outpatient Clinic, Community Health Center Koper
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose �b17.0 mmol/L or HbA1c �b16.5%)
- Current or recent (within 3 months) use of antidiabetic or anti-obesity medications
- Pregnancy, breastfeeding, or planned pregnancy during the study period
- Severe chronic diseases affecting glucose metabolism or participation (e.g., chronic liver disease, renal failure, active cancer)
- Endocrine disorders affecting metabolism (e.g., untreated thyroid disease, Cushing's syndrome)
- Severe psychiatric illness or cognitive impairment limiting adherence or understanding
- Use of medications affecting glucose metabolism (e.g., corticosteroids, atypical antipsychotics)
- Implanted electronic medical devices 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Primorska, Faculty of Health Sciences
Izola, Slovenia, 6310
Actively Recruiting
2
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
Koper, Slovenia, 6000
Actively Recruiting
3
Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
A
Ajda Urbas, medical doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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