Real-time glucose monitoring to help people with prediabetes see if their lifestyle changes work

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares continuous glucose monitoring (CGM) using Sibionics with standard self-monitoring in adults with prediabetes. Participants will be randomized to receive real-time CGM data and support or conventional glucose checks, over a 12-week period. The study collects glycemic markers and behavioral data to see if 24-hour monitoring aids adherence to diet, activity, and other lifestyle adjustments. It aims to determine whether CGM can provide actionable feedback that improves glycemic variability and overall metabolic control in the prediabetic range. Safety and feasibility data will also be gathered to inform future larger studies.

Why it matters

Who can join: the full rules

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's running

• Bogomolets National Medical University
  Kyiv, Ukraine Recruiting
• University Hospital of Bogomolets National Medical University
  Kyiv, Ukraine Recruiting
• Bogomoletz Institute of Physiology
  Kyiv, Ukraine Enrolling by invitation

Study contacts

• Principal investigator: Nazarii Kobyliak — Bogomolets National Medical University
• Study coordinator: Nazarii Kobyliak, Professor
• Email: nazariikobyliak@gmail.com
• Phone: +380442356005

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.