DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients

Prior treatment

• Diagnosed with clinically significant cardiovascular disease within 6 months prior to screening.

Other illness

• Unable to engage in study education due to severe systemic disorders(e.g., end-stage renal failure requiring dialysis, liver cirrhosis of Child-Pugh Class C or higher, etc)

Lab values

• Who have administered medications affecting glucose metabolism within 3 months before screening(e.g., corticosteroids, immunosuppressants) (Candidate with stable, ongoing dosage for over 6 months before screening are exempted from this criterion).
• Exhibiting an estimated glomerular filtration rate(eGFR)\<15 mL/min at the screening.

Other

• Participants with severe diabetic complications(e.g., diabetic foot, diabetic retinopathy, etc)
• Pregnant or lactating women

• Age between 19 and 75 years old.
• Confirmed diagnosis of Type 1 or Type 2 diabetes or post-pancreatectomy(total or partial) diabetes at least 1 year prior to screening.
• Currently using multiple dose insulin therapy at least 3 months prior to screening, regardless of Continuous Glucose Monitoring(CGM) usage.
• HbA1c levels between 7.5% and 12.0% at screening.