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

Launched by G2E CO., LTD · May 6, 2024

Keywords

ClinConnect Summary

The DIA:CONN P8 Study is a clinical trial that is looking at a new electric Smart Insulin Pen designed for people with diabetes. This study aims to see how well this smart pen works and whether it is safe for patients with Type 1 diabetes, Type 2 diabetes, or diabetes that occurs after surgery on the pancreas. The trial is currently recruiting participants aged 19 to 75 who have been using multiple daily insulin doses for at least three months and have certain blood sugar levels.

To be eligible, participants need to have been diagnosed with diabetes at least a year ago and meet specific health criteria. During the study, participants will learn how to use the Smart Insulin Pen and will have their health monitored closely. This trial is an important step in understanding how new technology can help people manage their diabetes more effectively. If you think you might be a good fit for this study, you can talk to your doctor for more information.

Gender

ALL

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)\<15 mL/min at the screening.
• • 4. 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)
• • 5. Participants with severe diabetic complications(e.g., diabetic foot, diabetic retinopathy, etc)
• • 6. Pregnant or lactating women

Trial Officials