An interventional study of CGM Sibionics and On-Call Extra Glucometer in Pre Diabetic, Obesity & Overweight and Insulin Resistance, sponsored by Nazarii Kobyliak. Recruiting at 3 sites in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Nazarii Kobyliak · Not applicable, Interventional, and Prevention
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.
Prediabetes is considered a critical stage at which effective prevention of the development of diabetes is possible, provided that early detection and adequate glycemic control. International clinical guidelines and multicenter studies suggest that early intensive glycemic control is associated with a better prognosis and a reduced risk of complications. However, standard self-monitoring has limited information on glycemic variability, which is especially important in the early stages of carbohydrate metabolism disorders, including prediabetes. Routine indicators such as fasting blood glucose, 1 and 2 hours after a meal, and glycated hemoglobin (HbA1c) do not always clearly differentiate between diabetes, prediabetes, and normal carbohydrate metabolism. Recently, there has been a need for more comprehensive blood glucose monitoring strategies that cover the entire spectrum of glycemic variability. Continuous glucose monitoring (CGMs) technology provides real-time glucose concentration data, overcoming the limitations of traditional monitoring methods. Recently, not only among people with diabetes, but also among people with prediabetes, there has been an increasing trend towards using CGM as a personal device to monitor glucose levels and promote healthy habits such as increased activity, diet, and sleep. Their motivation is to improve their own glycemic control and avoid the future development of diabetes and its associated complications, to optimize blood glucose levels to achieve peak mental or physical performance, and to use personal monitoring data to develop sustainable behavioral skills. The contactless 24-hour monitoring system is considered a promising tool for personalized glycemic control, but its use in people with prediabetes has not been studied enough This is a prospective, open-label, randomized controlled trial involving 80 adult patients with prediabetes recruited at the Bogomolets National Medical University. Participants were randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring (CGM group) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers). Participants will undergo a 3-month observation period. The use of the assigned monitoring devices (CGM or SMBG glucometer) and pedometers will last for the first 1 month. The study consists of three visits: Visit 1 (baseline), Visit 2 (1 month, end of intervention), and Visit 3 (3 months, follow-up period). During these visits, researchers will collect data on glycated hemoglobin (HbA1c), fructosamine, Cpeptide, HOMA-IR index, lipid profile, anthropometric indicators (body mass index (BMI), waist circumference), bioimpedance measurement, physical activity monitoring using pedometers, and SF-36 questionnaire to assess quality of life.
The gathered data will help determine whether continuous monitoring provided by CGM systems improves glycemic control and increases patient adherence to lifestyle changes compared to conventional SMBG methods.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 80 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Nazarii Kobyliak is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with prediabetes will be provided with a Real-Time Continuous Glucose Monitoring (RT-CGM) device to monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services. Pre and post intervention surveys and investigation will be implemented. Participants will be utilizing RT-CGM device for 28 days and then followed up for 3-month participation.
Device: CGM Sibionics
Participants with prediabetes will be provided with traditional fingerstick glucometer device to self-monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services. Pre and post intervention surveys and investigation will be implemented. Participants will be utilizing glucometer with at least 2-3 measurements per week for 28 days and then followed up for 3-month participation.
Device: On-Call Extra Glucometer
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.
Capillary glucose monitoring using fingerstick glucometer as per standard care.
Changes in HbA1c level
HbA1c in %
Time frame: at 3 month (end of follow-up period)
Changes in Fructosamine level
Fructosamine in μmol/L
Time frame: at 3 month (end of intervention period)
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 baseline
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 baseline
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 baseline
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 baseline
waist circumferences (WC)
WC in cm
Time frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
visceral fat content
visceral fat content using electronic scales-analyzers of body composition Huawei (Smart Scale series 3/3 Pro
Time frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Total Cholesterol (TC)
TC in mmol/l
Time frame: at 3 month (follow-up period) compared to baseline
Tryglicerides (TG)
TG in mmol/l
Time frame: at 3 month (follow-up period) compared to baseline
LDL-Cholesterol (LDL-C)
LDL-C in mmol/l
Time frame: at 3 month (follow-up period) compared to baseline]
Physical activity levels
Daily number of steps as measured by a sealed pedometer
Time frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Quality of Life Evaluation: Medical Outcomes Study Short-Form 36 (SF-36)
Health-related quality of life will be evaluated using the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire. The SF-36 consists of 36 items measuring 8 health domains, which are aggregated into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). For each domain and summary score, values are transformed to a scale ranging from a minimum of 0 to a maximum of 100. Higher scores represent better health status and a better quality of life outcome.
Time frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nazarii Kobyliak