Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin … (NCT07401901) | Clinical Trial Compass
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Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes
France, Germany, Italy230 participantsStarted 2026-10-15
Plain-language summary
The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.
Who can participate
Age range
18 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
. Is aged ≥ 18 years old at time of screening.
. Has a clinical diagnosis of Type 1 diabetes for ≥6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
. Is on commercially approved AID therapy (e.g. MiniMed 780G, Control IQ, OmniPod 5, CamAPS FX) for at least 3 months before screening.
. Has a glycosylated hemoglobin (HbA1c) above ≥7.5 % (59 mmol/mol), therefore is not achieving therapy goal, at time of screening visit (as processed by a Central Lab).
. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units.
. Has shown good compliance (≥70%) with sensor wear over the previous month prior to enrollment (based on sensor usage from the download summary report over the 30 days prior to enrollment).
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. Is willing to switch to an approved insulin per insulin pump labeling.
. Is willing to participate in all training sessions as directed by study staff.
Exclusion criteria
. Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
. Is using any anti-diabetic medication other than insulin at the time of the screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors).
. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take chronically any oral, injectable, or IV glucocorticoids during the course of the study.
. 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.
. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
. Has active or severe retinopathy in the last 6 months before the screening.
. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
. Has a positive pregnancy test at screening or plan to become pregnant during the course of the study or is breast feeding at the time of the enrollment.