Insulin Resistance, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes (T2DM)
Conditions
Keywords
obesity, continuous glucose monitoring, insulin resistance, traditional glycemia self-monitoring, type 2 diabetes
Brief summary
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.
Detailed description
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: * Visit 1 (Baseline); * Visit 2 (1 month, end of active intervention); * Visit 3 (3 months, end of follow-up period). 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.
Interventions
DEVICECGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.
DEVICEOn-Call Extra Glucometer
Capillary glucose monitoring using fingerstick glucometer as per standard care.
Sponsors
Nazarii Kobyliak
COR-Medical LLC
Iridium LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 18 years and older. * Newly diagnosed Type 2 Diabetes Mellitus according to ADA (American Diabetes Association) criteria (Fasting Plasma Glucose ≥ 7.0 mmol/L, or 2-hour Post-Prandial Glucose ≥ 11.1 mmol/L during OGTT, or HbA1c ≥6.5%). * Time since the initial diagnosis of T2D must not exceed 3 months ( less 90 days) at the time of screening. * HbA1c level between 6.5% and 9.5% (inclusive) at screening. * Patients may be lifestyle-controlled or receiving any stable non-insulin anti-diabetic therapy (including Metformin, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or Sulfonylureas) as monotherapy or combination therapy. * Ability to provide written informed consent and willingness to adhere to the study protocol and follow-up schedule.
Exclusion criteria
* Diagnosis or suspicion of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA) (e.g., positive anti-GAD antibodies if tested), or secondary types of diabetes (e.g., pancreatic or drug-induced). * Any prior or current use of insulin therapy. * Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR \< 45 mL/min/1.73m², diabetic foot ulcers, severe peripheral neuropathy). * Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia. * History of myocardial infarction, stroke, unstable angina, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) within the past 6 months. * Active malignancy, decompensated heart failure (NYHA Class III or IV), or chronic infectious diseases. * Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c level | at 3 month (end of follow-up period) | HbA1c in percent |
| Changes in Fructosamine level | at 1 month (end of intervention period) | Fructosamine in μmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR) | at 3 month (follow-up period) compared to baseline | 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). |
| insulin sensitivity (%S) | at 3 month (follow-up period) compared to baseline | This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism |
| β-cell function (%B) | at 3 month (follow-up period) compared to baseline | This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism |
| body mass index (BMI) | at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline | weight in kg and height in meters will be combined to report BMI in kg/m\^2 |
| waist circumferences (WC) | at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline | WC in cm |
| visceral fat content | at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline | visceral fat content using electronic scales-analyzers of body composition Huawei (Smart Scale series 3/3 Pro) |
| Total Cholesterol (TC) | at 3 month (follow-up period) compared to baseline | TC in mmol/l |
| Tryglicerides (TG) | at 3 month (follow-up period) compared to baseline | TG in mmol/l |
| LDL-Cholesterol (LDL-C) | at 3 month (follow-up period) compared to baseline] | LDL-C in mmol/l |
| Physical activity levels | at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline | Daily number of steps as measured by a sealed pedometer |
| Quality of Life Evaluation: Medical Outcomes Study Short-Form 36 (SF-36) | at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline | 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. |
Countries
Ukraine
Outcome results
None listed