NCT07004153Not yet recruiting
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 27 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- G2e Co., Ltd
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07004153
What you commit to
- Study type: Interventional
- Planned participants: 152
- From 1 Jun 2025 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Diabetes mellitus secondary to pancreatic resection.
Lab values
- eGFR \<15 mL/min at screening or those receiving dialysis
Other
- Pregnant or lactating women
Who the study is looking for
- 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.
Age in the registry: 19 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.