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 States, Australia, New Zealand400 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. 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.
Who can participate
Age range
7 Years – 85 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is listed as Phase NA and focuses on safety evaluation, what does that mean for how much is already known about the MiniMed NMX8-AID system's safety compared to AID systems that have already gone through full phase trials?
2This trial is measuring both time in range and time spent in hypoglycemia across three different study arms — can you explain which arm I might be placed in and how each arm differs in terms of what I'd be asked to do or what device settings I'd be using?
3Given that I have Type 1 diabetes, would my current A1C, my history of low blood sugars, or my existing insulin pump experience affect whether this trial might be a reasonable option to discuss as part of my care plan?
4The trial is currently recruiting, which means it's still in the enrollment phase — does participating in a safety evaluation study like this mean I might encounter risks or device behaviors that aren't yet fully understood, and how would those be monitored and managed?
5Is there a standard automated insulin delivery system already approved and available that my care team would recommend I consider first before exploring participation in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
2
Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
3
Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
4
Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
5
Study Arm 3: Percent of Time in Range (TIR 70-180 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
6
Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL)
Timeframe: Throughout the study period, approximately 90 days.
. 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).