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

Prior treatment

• Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:
  • Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
  • Coma or
  • Seizures
• Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
• T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
• Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.
• Is using inhalable insulin in the 8 weeks prior to screening.
• Is, at the discretion of the investigator, abusing drugs or alcohol.
• Has elective surgery planned that requires general anesthesia during the course of the study.
• Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
• 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.

Other illness

• Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Has diagnosis of adrenal insufficiency.
• 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.
• Is diagnosed with current eating disorder such as anorexia or bulimia.
• Has celiac disease that is not adequately treated as determined by the investigator.
• 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.
• Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

Lab values

• 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.
  • Participants who have stopped using metformin and/or GLP-1/GIP have done so at least 8 weeks prior to screening.
  • 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.
  • During continued access, starting/stopping the medication and/or modifying doses will be permitted.
  • Dose changes and reasons for changes will be documented throughout the study.
• 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.
  • 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.
  • 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.
  • During continued access, starting/stopping the medication and/or modifying doses will be permitted.
  • Dose changes and reasons for changes will be documented throughout the study
• Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c
• 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.

Other

• Unable to consent due to a mental or intellectual disability.
• Currently pregnant or planning to become pregnant during the time period of study participation
  • A negative pregnancy test will be required for all females of child-bearing potential at time of screening
  • 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
• At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.
• Is using hydroxyurea at time of screening or plans to use it during the study
• 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.
• Is, in the opinion of the investigator, not able to perform all study procedures safely.
• Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
• Is on dialysis.
• Is a member of the research staff involved with the study.

• Age at time of screening according to diabetes type:
  • T1D: Age 7-85 years
  • T2D: Age 18-85 years
• Has a clinical diagnosis of diabetes for a minimum per diabetes type below:
  • 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.
  • 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
• Is willing to provide informed consent/assent for participation.
• Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
• Is willing to wear the system continuously throughout the study.
• 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:
  • T1D adults (Age 18-85 years):
  • 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.
  • T2D adults (Age 18-85 years):
  • Results of a retinal eye exam, performed within the last 12-18 months, should be on record.
  • T1D pediatric (Age 7-17 years):
  • No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.
  • 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.
• Is willing to upload study pump data via an app or computer.
• Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
  • Humalog™\* (insulin lispro injection)
  • NovoLog™\* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™\*)
  • NovoRapid™\* (insulin aspart solution for injection)
  • Admelog™\* (insulin lispro injection)
  • Merilog™\* (insulin aspart)
  • Fiasp™\* (ultra-rapid-acting insulin aspart)
  • Lyumjev™\* (ultra-rapid-acting insulin lispro)
  • Authorized generic insulin aspart
  • Authorized generic insulin lispro