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

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 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.

Conditions4

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