Clinical trial

PREdiabetes GLycemic Impact and Data Evaluation

Recruiting now · Not applicable · 1 countries · Registry ID NCT07599072

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionPre Diabetic, Obesity & Overweight, Insulin Resistance

Full registry criteria

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.

Treatments and study arms

CGM Sibionics

Device

A registered medical device for real-time monitoring of glucose levels in interstitial fluid.

On-Call Extra Glucometer

Device

Capillary glucose monitoring using fingerstick glucometer as per standard care.

Primary outcomes

Changes in HbA1c levelat 3 month (end of follow-up period)

HbA1c in %

Changes in Fructosamine levelat 3 month (end of intervention period)

Fructosamine in μmol/L

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Bogomolets National Medical University🌐 Kyiv, Ukraine
Nazarii Kobyliak, ProfessorContact
Victoriia Yerokhovych, PhDContact
Bogomoletz Institute of Physiology🌐 Kyiv, Ukraine
University Hospital of Bogomolets National Medical University🌐 Kyiv, Ukraine
Ilona Rudneva, PhD studentContact
Ieva Ilkiv, PhD StudentContact