CompletedNot Applicable

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

South Korea120 participantsStarted 2024-05-21

Plain-language 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

Who can participate

Age range19 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).
✕. Diagnosed with clinically significant cardiovascular disease within 6 months prior to screening.
✕. Exhibiting an estimated glomerular filtration rate(eGFR)\<15 mL/min at the screening.
✕. 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)
✕. Participants with severe diabetic complications(e.g., diabetic foot, diabetic retinopathy, etc)
✕. Pregnant or lactating women

What they're measuring

Change in HbA1c(%) at 12 weeks compared to baseline

Timeframe: from baseline to the 12-week time point

Trial details

NCT IDNCT06406439

SponsorG2e Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-02

View on ClinicalTrials.gov More Diabetes (Insulin-requiring, Type 1 or Type 2) trials