Tests a smart insulin pen with glucose-sensor coaching in diabetes
Tests a smart insulin pen with coaching in adults with type 1 or 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
Key facts
- Where
- Seoul, South KoreaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 75 years old?
Source: NCT07004153, who can take part
Where in South Korea
- Samsung Medical CenterSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- G2e Co., Ltd
- Trial code
- NCT07004153
- Record updated
- 4 June 2025
- Original description
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 DiabetesRead full original descriptionShow less
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
Inclusion: Age between 19 and 75 years old; Diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening; Continuous use of MDI therapy for at least 3 months prior to screening, defined as one of the following regimens:; Long-acting insulin plus rapid-/short-acting insulin; Mixed insulin (e.g., insulin aspart/insulin degludec) plus rapid-/short-acting insulin; Mixed insulin ≥3 times per day; HbA1c of 7.5% to 12.0% at screening.
Exclusion: Use of corticosteroids exceeding a prednisolone-equivalent dose of 5 mg/day within 3 months prior to screening (Subjects on a stable dose for ≥3 months prior to screening may be eligible); Diabetes mellitus secondary to pancreatic resection; eGFR <15 mL/min at screening or those receiving dialysis; Pregnant or lactating women.