An interventional study of CGM Sibionics and On-Call Extra Glucometer in Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus and Obesity & Overweight, sponsored by Nazarii Kobyliak. Recruiting at 3 sites in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Nazarii Kobyliak · Not applicable, Interventional, and Prevention
This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers).
The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.
Newly diagnosed Type 2 Diabetes (T2D) represents a critical therapeutic window where intensive glycemic control can significantly preserve beta-cell function, reduce glycemic variability, and potentially induce diabetes remission. International guidelines emphasize that early, tight glycemic control is strongly associated with a better long-term prognosis and a reduced risk of micro- and macrovascular complications. However, traditional self-monitoring of blood glucose (SMBG) via finger-prick glucometers offers only static "snapshots" of glucose levels, missing critical fluctuations, asymptomatic hypoglycemia, and postprandial spikes. Routine indicators like fasting plasma glucose and glycated hemoglobin (HbA1c) fail to capture the full spectrum of glycemic variability, which is an independent risk factor for cardiovascular disease.
Recently, Continuous Glucose Monitoring (CGM) technology has emerged as a transformative tool, providing real-time, 24-hour glucose profiles. Beyond its clinical utility, CGM serves as a powerful biofeedback mechanism, motivating patients to adopt sustainable lifestyle changes-such as targeted physical activity, dietary adjustments, and improved sleep hygiene. While CGM is widely adopted in established diabetes management, its clinical utility, impact on patient adherence, and quality of life in individuals with newly diagnosed T2DM who are starting or optimizing non-insulin pharmacological therapies remain insufficiently explored.
This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers).
The intensive intervention period with the assigned monitoring devices (CGM or SMBG) and pedometers will last for the first 1 month, followed by a 2-month observation phase. The study consists of three outpatient visits:
During these visits, comprehensive metabolic, anthropometric, and psychological assessments will be conducted, including HbA1c, fructosamine, C-peptide, insulin resistance indices (HOMA2-IR), lipid profile, body mass index (BMI), waist circumference, bioimpedance body composition analysis, objective physical activity monitoring (pedometer data), and the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire to evaluate health-related quality of life.
The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.
Exclusion Criteria:
articipants 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 percent
Time frame: at 3 month (end of follow-up period)
Changes in Fructosamine level
Fructosamine in μmol/L
Time frame: at 1 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
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Nazarii Kobyliak