GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Dia… (NCT07228117) | Clinical Trial Compass
RecruitingNot Applicable
GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
United States400 participantsStarted 2026-02-02
Plain-language summary
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. Patients 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. 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.
Who can participate
Age range
7 Years – 85 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
What they're measuring
1
Overall: Percent of Time in Range (TIR 70-180 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
2
Overall: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
3
Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
4
Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
5
Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
6
Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
7
Study Arm 3: Percent of Time in Range (TIR 70-180 mg/dL)
. Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
Exclusion criteria
. Unable to consent due to a mental or intellectual disability.
. 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.
. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
Timeframe: Throughout the study period, approximately 90 days.
8
Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.