PREdiabetes GLycemic Impact and Data Evaluation
Recruiting · NCT07599072 · Interventional (participants receive a specific treatment) · Lead sponsor: Nazarii Kobyliak
View the official record on ClinicalTrials.gov →Interventions studied
CGM SibionicsOn-Call Extra Glucometer
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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;
- Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia;
- Pregnancy or lactation;
- Mental or cognitive impairments that would interfere with study participation;
- Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months;
- Recent use of any CGM within the last 12 months;
- Known allergy to sensor materials;
- Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant;
- Participation in another clinical study within the last 3 months.
Where it is running
3 locations listed.
- Bogomoletz Institute of Physiology - Kyiv, Ukraine
- Bogomolets National Medical University - Kyiv, Ukraine
- University Hospital of Bogomolets National Medical University - Kyiv, Ukraine