The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.
Is aged ≥ 18 years old at time of screening.
Has a clinical diagnosis of Type 1 diabetes for ≥6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
Is on commercially approved AID therapy (e.g. MiniMed 780G, Control IQ, OmniPod 5, CamAPS FX) for at least 3 months before screening.
Has a glycosylated hemoglobin (HbA1c) above ≥7.5 % (59 mmol/mol), therefore is not achieving therapy goal, at time of screening visit (as processed by a Central Lab).
Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
Is using any anti-diabetic medication other than insulin at the time of the 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 chronically any oral, injectable, or IV glucocorticoids during the course of the study.
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 System - Treatment arm
DeviceSubjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).
AID Therapy
DeviceSubjects will continue to use their current AID therapy during the study phase (6-month).
NMX8 System - Control Arm
DeviceSubjects start using the NMX8 system during the continuation phases (3-month).
Primary Endpoint
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time that the sensor glucose (SG) measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase . The endpoint will be assessed for non-inferiority.
Secondary Endpoint 1
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase. The endpoint will be assessed for non-inferiority.
Secondary Endpoint 2
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase. The endpoint will be assessed for superiority.
Secondary Endpoints 3
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time spent in target range 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase. The Endpoint will be assessed for superiority.
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