16 September 2026 editorial review · Trial
GATEWAY: MiniMed Flex / NMX8-AID with Simplera Sync: 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.
Read the trial evidence page →Baseline trial evidence review: M–S
Outcome: Added current active-not-recruiting status, actual389 enrollment and estimated January2027 completion; product clearance is not trial outcome data.
Registry: NCT07228117. Endpoint reviewed: Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 3: Percent of Time in Range (TIR 70-180 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL) (Throughout the study period, approximately 90 days.). Eligibility reviewed: Age 7 Years to 85 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.