MiniMed NMX8 automated insulin delivery system vs 780G in people with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pre-market, randomized, open-label study conducted at multiple centers. After a run-in period on 780G therapy to establish baseline CGM data, participants are randomized to either start using the NMX8 system or continue with 780G for 12 weeks, with all participants using the Simplera Sync sensor. The primary aim is to assess safety and performance of the NMX8 compared with 780G in real-world use. Eligible participants include both children and adults with type 1 or type 2 diabetes who are already using 780G and meet HbA1c and insulin criteria. The study includes training and follow-up visits to monitor device operation and outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Is aged ≥2 years old at time of screening.
2. Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
3. Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
4. Has a glycosylated hemoglobin (HbA1c) \<11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
6. Willing to switch to approved insulin per insulin pump labeling.
7. Investigator has confidence that the subject, parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.
8. Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
9. Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
10. For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.
11. For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.

Exclusion Criteria:

1. Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
2. For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors).
3. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement
4. Has had renal failure defined by creatinine clearance \<30 ml/min, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
5. Has active or severe retinopathy in the last 6 months before screening
6. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
8. History of 2 or more DKA events in the last 3 months before screening.
9. Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
10. Is using hydroxyurea at time of screening or plans to use it during the study
11. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
12. Women who are breastfeeding.
13. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before screening, as per investigator judgment.
14. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
15. Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.
16. Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.

Where it's running

• Universitair Ziekenhuis Antwerpen
  Antwerp, Belgium Recruiting
• Cliniques Universitaires de Bruxelles - Hôpital Erasme
  Brussels, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Steno Diabetes Center Aarhus
  Aarhus, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting

Study contacts

• Study coordinator: Renée Tillie, PhD
• Email: renee.tillie@medtronic.com
• Phone: +31627363854

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.