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DIabetes GLycemic Assessment in Newly Confirmed Episodes

Sponsor: Nazarii Kobyliak • ClinicalTrials.gov ID: NCT07690163

Registry updated: 2026-09-29

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Description

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.

Interventions

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.

Eligibility criteria

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.

Conditions

Type 2 Diabetes (T2DM) Obesity Type 2 Diabetes Mellitus Obesity & Overweight Insulin Resistance

Locations

Bogomolets National Medical University — Kyiv, Ukraine
Bogomoletz Institute of Physiology — Kyiv, Ukraine
University Hospital of Bogomolets National Medical University — Kyiv, Ukraine

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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