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16 September 2026 editorial review · Trial

Luna AID system safety and effectiveness: 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: NCT06627517; ACTIVE_NOT_RECRUITING; updated 2025-08-27; enrollment 120 (ESTIMATED); results not posted.

Endpoint comparison: Severe hypoglycemia events (From device activation to the end of treatment at 13 weeks); Diabetic ketoacidosis events (From device activation to the end of treatment at 13 weeks); Change in CGM-measured time in range (70-180 mg/dL) (From device activation to the end of treatment at 13 weeks).

Sources for this record: NCT06627517: Luna AID system safety and effectiveness (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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