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16 September 2026 editorial review · Trial

UBLoop-Genesis early feasibility study: review notes

These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.

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Primary-agent trial review — 16 September 2026

Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.

Registry: NCT07087340; COMPLETED; updated 2026-07-16; enrollment 6 (ACTUAL); results not posted.

Endpoint comparison: Percentage of time with the system functioning in closed-loop mode (10 hours); Failure rate of the HCL algorithm (10 hours); Failure rate of the communication with CGM device (10 hours); Failure rate of the communication with Insulin pump (10 hours); Failure rate of the user interface (BernSHELL) (10 hours); Failure rate of the web monitoring tool (DigiCARE) (10 hours).

Sources for this record: NCT07087340: UBLoop-Genesis early feasibility study (registry).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.

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