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NCT07690163Recruiting

DIabetes GLycemic Assessment in Newly Confirmed Episodes

Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
1 Jul 2026
Start date
15 Jul 2026
Primary completion date
31 Mar 2027
Lead sponsor
Nazarii Kobyliak
NCT number
NCT07690163

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 15 Jul 2026 to the primary completion date, 31 Mar 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior or current use of insulin therapy.

Other illness

  • 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).
  • 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.
  • 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.

Lab values

  • Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR \< 45 mL/min/1.73m², diabetic foot ulcers, severe peripheral neuropathy).

Other

  • Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception.
  • Participation in another clinical study within the last 3 months.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Bogomolets National Medical University
Coordinator of this site? Confirm its status
KyivUkraineRecruiting
Bogomolets National Medical University
Coordinator of this site? Confirm its status
KyivUkraineRecruiting
Bogomoletz Institute of Physiology
Coordinator of this site? Confirm its status
KyivUkraineEnrolling by invitation

This page is information, not medical advice. Discuss any trial with your doctor.