iLet Experience real-world safety and effectiveness study
What this study tests
Beta Bionics prospective real-world cohort collecting one-year safety and effectiveness data for the iLet Dosing Decision Software in people aged 6 and older with type 1 diabetes.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-09-08.
Most recent recorded citation date: 2025-03-24. 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?
- People aged 6 and older with type 1 diabetes using the iLet Bionic Pancreas. 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
- No results posted yet.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: United States. 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
- Severe hypoglycemia or cognitive impairment over 1 year
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]The iLet Experience Study · Trial registry · 2025-03-24