PREdiabetes GLycemic Impact and Data Evaluation
This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study
| Condition(s) | Pre Diabetic, Obesity & Overweight, Insulin Resistance |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods. |
| Who can participate | Inclusion Criteria: * Age of 18 years and older. * Presence of prediabetes diagnosed according to criteria of the American Diabetes Association * Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study; * Ability to comply with protocol requirements and maintain a patient diary. * Signed informed consent. Exclusion Criteria: * Presence of type 1 or type 2 diabetes; * Decompensated liver or kidney diseases (GFR \< 45 ml/min/1. 73 m²); * Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Nazarii Kobyliak |
| Locations | Kyiv, Ukraine; Kyiv, Ukraine |
| Start date | 2026-05-01 |
| NCT ID | NCT07599072 |
| Official listing | https://clinicaltrials.gov/study/NCT07599072 |