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A Multicenter, Open Label, Randomized, Comparative Confirmatory Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen (DIA:CONN P8) Including Setup Wizard, Advanced Insulin Injection Coaching and Bolus Calculator With Analysis Function Based on Continuous Glucose Monitoring Data in Patients With Type 1 or Type 2 Diabetes Mellitus Under Multiple Dose Insulin Therapy
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
Details
| Lead sponsor | G2e Co., Ltd |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 152 |
| Start date | 2025-06 |
| Completion | 2026-12 |
Conditions
- Diabetes Mellitus
Interventions
- Smart Coaching Insulin Pen
Primary outcomes
- Change in HbA1c(%) at 12 weeks compared to baseline — from baseline to the 12-week time point
Descriptive statistics (sample size, mean, standard deviation, median, minimum, and maximum) are provided for the change in HbA1c (%) from baseline to the 12-week time point, stratified by group.
Countries
South Korea