NCT07423065Suspended
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 15 Dec 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University of Primorska
- Diseases
- Obesity
- NCT number
- NCT07423065
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 15 Dec 2026 to the primary completion date, 1 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any antidiabetic medication (insulin, metformin, GLP-1RA, SGLT2i, etc.), or anti-obesity pharmacotherapy.
- Participation in another interventional study within the previous 3 months.
Other illness
- Endocrine disorders affecting metabolism (e.g., untreated thyroid disease, Cushing's syndrome).
- Severe psychiatric illness or cognitive impairment limiting adherence or comprehension.
- Known allergy or skin reaction to CGM adhesives or device materials.
Lab values
- Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%).
- Severe chronic disease that could influence glucose metabolism or study participation (e.g., chronic liver disease, renal failure, active malignancy).
- Use of medications known to affect glucose metabolism (e.g., corticosteroids, atypical antipsychotics).
Other
- Current or recent (within 3 months) use of:
- Pregnancy, breastfeeding, or planned pregnancy during the study period.
- Implanted electronic medical devices (e.g., pacemaker, defibrillator) that may interfere with CGM function.
Who the study is looking for
- 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).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Primorska, Faculty of Health Sciences Coordinator of this site? Confirm its status | Izola | Slovenia | Unknown status |
| Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia Coordinator of this site? Confirm its status | Koper | Slovenia | Unknown status |
| Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.