DIabetes GLycemic Assessment in Newly Confirmed Episodes

Korábbi kezelés

• Any prior or current use of insulin therapy.

Más betegség

• 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.

Laborértékek

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

Egyéb

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

• 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.