Real-Time Glucose Monitoring in Newly Diagnosed Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized trial enrolling 80 adults with T2DM diagnosed within the last 3 months. Participants are assigned to either real-time continuous glucose monitoring (CGM) or standard self-monitoring of blood glucose (SMBG) with traditional glucometers. The trial compares effects on glycemic variability, metabolic parameters, and adherence to lifestyle and treatment recommendations. Eligible participants may be on stable non-insulin diabetes medications or lifestyle-managed. The study uses CGM systems (Sibionics) with an on-call glucometer to support feedback-driven management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bogomolets National Medical University
  Kyiv, Ukraine Recruiting
• University Hospital of Bogomolets National Medical University
  Kyiv, Ukraine Recruiting
• Bogomoletz Institute of Physiology
  Kyiv, Ukraine Enrolling by invitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.