Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • CGM Sibionics
  • On-Call Extra Glucometer

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

3
Bogomolets National Medical University01601, Kyiv Ukraine
Bogomoletz Institute of Physiology01024, Kyiv Ukraine
University Hospital of Bogomolets National Medical University01601, Kyiv Ukraine

Sponsors and collaborators

Nazarii Kobyliak

Lead sponsor

Bogomolets National Medical University

Sponsor institution

COR-Medical LLC

Collaborator

Iridium LLC

Collaborator

Source ClinicalTrials.gov