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New insulin tech aims to improve blood sugar control in type 1 diabetes

NCT ID NCT07401901

Disease control Sponsor: Medtronic MiniMed, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new automated insulin delivery system (NMX8) in 230 adults with type 1 diabetes who are not meeting their blood sugar goals. Participants will use either the NMX8 system or another approved system to see which helps keep blood sugar in the target range more often. The goal is to improve daily diabetes management, not to cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is aged ≥ 18 years old at time of screening. 2. 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. 3. Is on commercially approved AID therapy (e.g. MiniMed 780G, Control IQ, OmniPod 5, CamAPS FX) for at least 3 months before screening. 4. 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). 5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units. 6. 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). 7. Is willing to switch to an approved insulin per insulin pump labeling. 8. Is willing to participate in all training sessions as directed by study staff. 9. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol. 10. Subject is willing and able to provide written informed consent. Exclusion Criteria: 1. Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment. 2. 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). 3. 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. 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 any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 6. Has active or severe retinopathy in the last 6 months before the screening. 7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment. 8. 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. Note: Different effective contraception methods may be used such as contraceptive pills, condoms, intra-uterine device, patches, rings, or long-active reversible contraceptive methods, as per routine practice. 9. History of 2 or more DKA events in the last 3 months before screening. 10. Is on "DIY" therapy at the time of the screening or at least 3 months before the screening. 11. Is planning to change AID therapy during the course of the study. Note: subjects randomized in the Control Arm should remain on their current therapy during the course of the study. 12. 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 enrollment into this study, as per investigator judgment. 13. Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment. 14. Is part of the research staff involved with the study. 15. Is legally incompetent, illiterate or vulnerable person.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Helping Behavior type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabete type 1 Type 1 diabetes (T1D)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam University Medical Center (Amsterdam UMC)

    Amsterdam, Netherlands

  • Azienda Ospedaliera Ospedale Niguarda Cà Granda

    Milan, Italy

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Italy

  • CHU de Nîmes - Hôpital Universitaire Caremeau

    Nîmes, France

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Centre Hospitalier Universitaire de Caen

    Caen, France

  • Die Praxisgemeinschaft für Endokrinologie und Diabetes

    Rostock, Germany

  • Fondazione Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore

    Roma, Italy

  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

    Bad Oeynhausen, Germany

  • Hopital Lariboisiere & Fernand-Widal

    Paris, France

  • Hospices Civils de Lyon (DIAB-e CARE)

    Lyon, France

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Universitari Clínic de Barcelona

    Barcelona, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hôpital Michallon - CHU Grenoble

    Grenoble, France

  • Leicester General Hospital

    Leicester, United Kingdom

  • Maastricht University Medical Center (UMC)

    Maastricht, Netherlands

  • Manchester University NHS Foundation Trust - Manchester Royal Infirmary

    Manchester, United Kingdom

  • Policlinico Sant' Orsola - Malpighi

    Bologna, Italy

  • ZGT Almelo

    Almelo, Netherlands

  • Zentrum für digitale Diabetologie Hamburg

    Hamburg, Germany

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