Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes

Prior treatment

• 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 active or severe retinopathy in the last 6 months before the screening.
• History of 2 or more DKA events in the last 3 months before screening.
• Is on "DIY" therapy at the time of the screening or at least 3 months before the screening.
• Is planning to change AID therapy during the course of the study. Note: subjects randomized in the Control Arm should remain on their current therapy during the course of the study.
• Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
• Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.

Other illness

• Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
• Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

Lab values

• 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.

Other

• 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 a positive pregnancy test at screening or plan to become pregnant during the course of the study or is breast feeding at the time of the enrollment.
  • Note: Different effective contraception methods may be used such as contraceptive pills, condoms, intra-uterine device, patches, rings, or long-active reversible contraceptive methods, as per routine practice.
• Is part of the research staff involved with the study.
• Is legally incompetent, illiterate or vulnerable person.

• 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).
• Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units.
• Has shown good compliance (≥70%) with sensor wear over the previous month prior to enrollment (based on sensor usage from the download summary report over the 30 days prior to enrollment).
• Is willing to switch to an approved insulin per insulin pump labeling.
• Is willing to participate in all training sessions as directed by study staff.
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol.
• Subject is willing and able to provide written informed consent.