PREdiabetes GLycemic Impact and Data Evaluation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNazarii Kobyliak
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CGM Sibionics
DeviceA registered medical device for real-time monitoring of glucose levels in interstitial fluid.
On-Call Extra Glucometer
DeviceCapillary glucose monitoring using fingerstick glucometer as per standard care.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CGM groupExperimental treatment 1 intervention
Group B: traditional fingerstick glucometerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in HbA1c level
HbA1c in %
Time frame
at 3 month (end of follow-up period)2
Changes in Fructosamine level
Fructosamine in μmol/L
Time frame
at 3 month (end of intervention period)Secondary outcomes
1
Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR)
HOMA2-IR will be calculated based on fasting plasma glucose and fasting serum insulin levels using the non-linear Homeostasis Model Assessment. The score is continuous, theoretically starting from 0, where higher values indicate greater insulin resistance (a worse clinical outcome).
Time frame
at 3 month (follow-up period) compared to baseline2
insulin sensitivity (%S)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
Time frame
at 3 month (follow-up period) compared to baseline3
β-cell function (%B)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
Time frame
at 3 month (follow-up period) compared to baseline4
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m\^2
Time frame
at 1 month (end of intervention) and 3 month (follow-up period) compared to baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nazarii Kobyliak
Lead sponsor
Bogomolets National Medical University
Sponsor institution
COR-Medical LLC
Collaborator
Iridium LLC
Collaborator
Source ClinicalTrials.gov