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Official title The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity
ClinicalTrials.gov ID: NCT07423065
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Stable body weight (±3 kg) in the last 3 months.
- No current use of antidiabetic or weight-loss medications.
You likely can't join if
- 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).
See the full eligibility 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).
- 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 treatment study within the previous 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Izola, Slovenia
- Koper, Slovenia
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Izola, Slovenia; Koper, Slovenia; Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.