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.
Is aged ≥2 years old at time of screening.
Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors).
Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement
Has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
Parallel
NMX8
DeviceSubjects will start using the MiniMed™ NMX8 system for 12 weeks
780G
DeviceSubjects will continue to use the MiniMed™ 780G for 12 weeks
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.
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.
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.
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.
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