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Completed
NCT06406439
DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients
Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2), Pancreatogenic Diabetes Mellitus
Sex: All
Ages: 19 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: G2e Co., Ltd
Location: Chung-Ang University Gwangmyeong Hospital Gwangmyeong Deokan-ro
Summary
A Multicenter, Open label, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIA:CONN P8 in patients with Type 1, Type 2 or Pancreatogenic Diabetes Mellitus under Multiple Dose Insulin Therapy
Eligibility Criteria
Inclusion Criteria:
1. Age between 19 and 75 years old.
2. Confirmed diagnosis of Type 1 or Type 2 diabetes or post-pancreatectomy(total or partial) diabetes at least 1 year prior to screening.
3. Currently using multiple dose insulin therapy at least 3 months prior to screening, regardless of Continuous Glucose Monitoring(CGM) usage.
4. HbA1c levels between 7.5% and 12.0% at screening.
Exclusion Criteria:
1. 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).
2. Diagnosed with clinically significant cardiovascular disease within 6 months prior to screening.
3. Exhibiting an estimated glomerular filtration rate(eGFR)\
Source: ClinicalTrials.gov (NCT06406439). StuddyBuddy aggregates publicly available trial information.
