DIabetes GLycemic Assessment in Newly Confirmed Episodes
Recruiting · NCT07690163 · Interventional (participants receive a specific treatment) · Lead sponsor: Nazarii Kobyliak
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
3 locations listed.
- Bogomolets National Medical University - Kyiv, Ukraine
- Bogomoletz Institute of Physiology - Kyiv, Ukraine
- University Hospital of Bogomolets National Medical University - Kyiv, Ukraine