Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)

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.

Inclusion criteria

• 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.
• Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
• Willing to switch to approved insulin per insulin pump labeling.
• Investigator has confidence that the subject, parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.
• Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
• Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
• For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.
• For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.

Exclusion criteria

• 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.
• Has active or severe retinopathy in the last 6 months before screening
• 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.
• History of 2 or more DKA events in the last 3 months before screening.
• Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
• Is using hydroxyurea at time of screening or plans to use it during the study
• Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
• Women who are breastfeeding.
• 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 screening, as per investigator judgment.
• Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
• Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.
• Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.