GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes

GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes

The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5/Simplera Sync in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Participants will use their current therapy while also wearing the DS5/Simplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if participants like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.

Inclusion Criteria:

1. Age at time of screening according to diabetes type:

   1. T1D: Age 7-85 years
   2. T2D: Age 18-85 years

2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:

   1. T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
   2. T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

3. Is willing to provide informed consent/assent for participation.

4. Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.

5. Is willing to wear the system continuously throughout the study.

6. Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:

   1. T1D adults (Age 18-85 years):

      I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.

   2. T2D adults (Age 18-85 years):

      I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.

   3. T1D pediatric (Age 7-17 years):

   I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.

   II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.

   Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.

7. Is willing to upload study pump data via an app or computer.

8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:

   1. Humalog™* (insulin lispro injection)
   2. NovoLog™* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™*)
   3. NovoRapid™* (insulin aspart solution for injection)
   4. Admelog™* (insulin lispro injection)
   5. Merilog™* (insulin aspart)
   6. Fiasp™* (ultra-rapid-acting insulin aspart)
   7. Lyumjev™* (ultra-rapid-acting insulin lispro)
   8. Authorized generic insulin aspart
   9. Authorized generic insulin lispro

Exclusion Criteria:

1. Unable to consent due to a mental or intellectual disability.

2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:

   1. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
   2. Coma or
   3. Seizures

3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.

4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.

5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

6. Currently pregnant or planning to become pregnant during the time period of study participation

   1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening
   2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable

7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.

8. Has diagnosis of adrenal insufficiency.

9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.

10. T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.

    1. Participants who have stopped using metformin and/or GLP-1/GIP have done so at least 8 weeks prior to screening.
    2. Participants currently taking metformin and/or GLP-1/GIP must be on a steady dose and remain on the same dose during study participation until the end of the study period.
    3. During continued access, starting/stopping the medication and/or modifying doses will be permitted.
    4. Dose changes and reasons for changes will be documented throughout the study.

11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 /GIP containing medications (e.g., Mounjaro), DPP-4 Inhibitors, thiazolidinedione (TZD), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.

    1. Participants who have stopped using metformin, GLP-1/GIP, DPP-4 Inhibitors, TZD, or SGLT2 have done so at least 8 weeks prior to screening.
    2. Participants currently taking metformin, GLP-1/GIP, DPP-4 Inhibitors, TZD, or SGLT2 must be on a steady dose and remain on the same dose during study participation, until the end of the study period.
    3. During continued access, starting/stopping the medication and/or modifying doses will be permitted.
    4. Dose changes and reasons for changes will be documented throughout the study

12. Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.

13. Is using inhalable insulin in the 8 weeks prior to screening.

14. Is using hydroxyurea at time of screening or plans to use it during the study

15. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study.

16. Is, at the discretion of the investigator, abusing drugs or alcohol.

17. Is, in the opinion of the investigator, not able to perform all study procedures safely.

18. Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator.

19. Has elective surgery planned that requires general anesthesia during the course of the study.

20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.

21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.

22. Is diagnosed with current eating disorder such as anorexia or bulimia.

23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c

24. Is on dialysis.

25. Has an estimated Glomerular Filtration Rate (eGFR) <30. For T1D subjects who are within the first 5 years after diagnosis, a new eGFR test is not required for screening; however, if an eGFR value taken during the first 5 years from diagnosis is available, and if it is <30, the subject will be excluded.

26. Has celiac disease that is not adequately treated as determined by the investigator.

27. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

28. Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

29. Is a member of the research staff involved with the study.

30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).