Not Yet RecruitingNot Applicable

A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes

South Korea152 participantsStarted 2025-06

Plain-language summary

Age range19 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. HbA1c of 7.5% to 12.0% at screening.

✕. Diabetes mellitus secondary to pancreatic resection.
✕. 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).
✕. eGFR \<15 mL/min at screening or those receiving dialysis
✕. Pregnant or lactating women

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

Timeframe: from baseline to the 12-week time point

NCT IDNCT07004153

SponsorG2e Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

SOOHYUN YOON