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type1.science
N/A (device / behavioral)RecruitingNCT07228117

GATEWAY: MiniMed Flex / NMX8-AID with Simplera Sync

MiniMed pivotal safety study of the system now publicly launched as MiniMed Flex and still registered under the NMX8-AID name, paired with the DS5 / Simplera Sync sensor. Participants use current therapy with the sensor first, then about 90 days of Flex/NMX8 in one of three meal-bolus modes, including a no-meal-bolus arm. Flex received FDA clearance in March 2026, but GATEWAY outcomes are not posted yet.

Primary endpoints

  • Time in range 70-180 mg/dL during approximately 90 days of NMX8 use
  • Time below 70 mg/dL during approximately 90 days of NMX8 use

Results so far

No results posted yet.