DIA:CONN P8 smart-insulin-pen randomized study
What this study tests
Completed 12-week randomized comparison in which both groups used the DIA:CONN P8: the intervention group used its app-supported carbohydrate/meal bolus calculator, while the control group entered doses manually and used only injection and dose-recording functions.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-05.
Most recent recorded citation date: 2024-05-09. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 19-75 with insulin-requiring type 1, type 2 or pancreatogenic diabetes on multiple daily injections; see registry for full criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- The South Korean study completed on 2 April 2025 with 120 participants. No results have been posted, and its mixed diabetes population cannot establish a T1D-specific benefit without subgroup data.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Change in HbA1c from baseline to 12 weeks
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT06406439: DIA:CONN P8 smart-insulin-pen study · Trial registry · 2024-05-09 — COMPLETED; actual n=120; South Korea; mixed type 1, type 2 and pancreatogenic diabetes population; no posted results as of 2026-08-08; registry update posted 2026-08-05. Both groups used the P8 hardware; the randomized contrast was decision support versus manual dosing.