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

Who can participate

Age range

19 Years – 75 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 IDNCT07004153

SponsorG2e Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

SOOHYUN YOON

+82-10-3352-4744 soohyun.yoon@g2e.co.kr

View on ClinicalTrials.gov More Diabetes Mellitus trials