This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.
This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study. The study consists of a run-in phase and a study phase. Run-in Phase: The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor. At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm). Study Phase: During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Primary Endpoint
The between-treatment (control arm with 780G system versus treatment arm with NMX8 system) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) with a non-inferiority testing.
Time frame: During the 12-week study phase
Secondary Endpoint 1
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with a non-inferiority testing.
Time frame: End of 12-week Study Phase
Secondary endpoint 2
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in % of Time spent in target range (70 to 180 mg/dL \[3.9 - 10.0 mmol/L\]) during the study phase with superiority test.
Time frame: During the 12-week Study Phase
Secondary Endpoint 3
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with superiority testing.
Time frame: End of the 12-week Study Phase
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