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Safety test of the MiniMed NMX8-AID insulin pump with the DS5/Simplera sensor in children and adults with diabetes

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

Not applicable Interventional Medtronic MiniMed, Inc. · NCT07228117

This test checks whether the MiniMed NMX8 insulin pump paired with the DS5/Simplera continuous glucose sensor is safe for children and adults with Type 1 diabetes and adults with insulin‑requiring Type 2 diabetes.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment400 (estimated)
Ages7 Years to 85 Years
SexAll
SponsorMedtronic MiniMed, Inc. Industry-sponsored
Locations36 sites (Little Rock, Arkansas and 35 other locations)
Trial IDNCT07228117 on ClinicalTrials.gov

What this trial studies

Participants with Type 1 (ages 7–85) or insulin‑requiring Type 2 diabetes (ages 18–85) first wear the DS5/Simplera sensor while continuing their usual therapy for up to 40 days and keep meal and exercise logs. After that run‑in period, they are randomized by computer into one of three groups and use the MiniMed NMX8‑AID pump for 90 days with group‑specific meal bolus instructions while continuing required logs. Safety events, device performance, and user experience are monitored throughout the 90‑day period, and participants who wish to keep the pump may be able to enter a Continued Access Period. The trial is conducted at outpatient clinical sites and requires prior retinal exam documentation and ability to use study materials in English or Spanish.

Who should consider this trial

Good fit: Ideal candidates are people with a clinical diagnosis of Type 1 diabetes aged 7–85 or insulin‑requiring Type 2 diabetes aged 18–85 who can consent/assent, read English or Spanish study materials, agree to wear the system continuously, and have a recent retinal exam on record.

Not a fit: Those who are not using insulin, have very recent Type 1 diagnoses (<6 months) or non‑insulin‑requiring Type 2 diabetes, cannot tolerate or wear a pump/sensor, lack the required retinal exam, or cannot use English or Spanish materials are unlikely to benefit from this study.

Why it matters

Potential benefit: If safe, the NMX8 system could offer people with diabetes an automated insulin delivery option that may simplify glucose management and reduce high and low glucose events.

How similar studies have performed: Other automated insulin delivery systems have shown improved glucose control and acceptable safety in prior randomized and real‑world studies, so the general approach is established though this specific device is being newly tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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. 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), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.

    1. Participants who have stopped using metformin, GLP-1/GIP or SGLT2 have done so at least 8 weeks prior to screening.
    2. Participants currently taking metformin, GLP-1/GIP or SGLT2 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
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.
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).

Where this trial is running

Little Rock, Arkansas and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 1 Diabetes MellitusType 2 Diabetes Mellitus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.