GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Status
Conditions
Treatments
Details and patient eligibility
About
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 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. Patients will use their current therapy while also wearing the DS5 for up to 40 days. During this time, they will complete a meal and exercise log. Patients will then be put into one of three groups by a computer by chance and given the NMX8 pump to use for 90 days. During this time, patients will either bolus or not bolus 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 patients 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Age at time of screening according to diabetes type:
- T1D: Age 7-85 years
- T2D: Age 18-85 years
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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
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Is willing to provide informed consent/assent for participation.
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Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
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Is willing to wear the system continuously throughout the study.
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Has a retinal eye examination prior to enrollment (if needed) per guidelines by the local professional society/hospital guidelines according to age, duration of diabetes and type of diabetes. Entry into the study is permitted at the investigators' discretion, depending on their interpretation of the findings.
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Is willing to upload study pump data via an app or computer.
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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™*/NovoRapid™* (insulin aspart solution for injection)
- Admelog™* (insulin lispro injection)
- Merilog™* (insulin aspart)
- Authorized generic insulin aspart
- Authorized generic insulin lispro
Exclusion criteria
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Unable to consent due to a mental or intellectual disability.
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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
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Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
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T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
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Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
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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 prior to enrollment
- 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
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At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.
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Has diagnosis of adrenal insufficiency.
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Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.
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T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1), in the 8 weeks prior to screening.
- Participants who have stopped using metformin and/or GLP-1 have done so at least 6 weeks prior to screening.
- Participants currently taking metformin and/or GLP-1 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study.
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T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1, Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.
- Participants who have stopped using metformin, GLP-1 or SLT-2 have done so at least 6 weeks prior to screening.
- Participants currently taking metformin, GLP-1 or SGLT-2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study
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Is using sulfonylureas and meglitinides, e.g. repaglinide
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Is using inhalable insulin in the 8 weeks prior to screening.
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Is using hydroxyurea at time of screening or plans to use it during the study
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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.
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Is, at the discretion of the investigator, abusing drugs or alcohol.
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Is, in the opinion of the investigator, not able to perform all study procedures safely.
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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.
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Has elective surgery planned that requires general anesthesia during the course of the study.
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Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
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Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
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Is diagnosed with current eating disorder such as anorexia or bulimia.
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Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c
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Is on dialysis.
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Has an estimated Glomerular Filtration Rate (eGFR) <30.
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Has celiac disease that is not adequately treated as determined by the investigator.
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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.
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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.
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Is a member of the research staff involved with the study.
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Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
Trial design
Primary purpose
Allocation
Interventional model
Masking
400 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Thomas Troub; Shannon Bondy
Data sourced from clinicaltrials.gov
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