Not yet recruitingNAINTERVENTIONAL

Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes

This research study is looking at a new automated insulin delivery system, called NMX8, for adults in the UK living with Type 1 diabetes. The main goal is to check if the NMX8 system is safe and works better than current automated systems for people who aren't currently reaching their blood sugar targets. Participants will either use the new NMX8 system or continue with their existing automated insulin delivery for six months. We'll be comparing how well their blood sugar is controlled and any side effects. This information will help us understand if the NMX8 could be a good future treatment option.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Medtronic MiniMed, Inc.

Enrolment target

230

Start

15 Oct 2026

Estimated completion

29 Mar 2028

Type 1 Diabetes (T1D)

What is this study about?

This study is investigating a new device for managing Type 1 diabetes called the Medtronic NMX8 System. This system is designed to automatically deliver insulin based on your blood sugar levels, aiming to make managing your diabetes easier and more effective. We want to see how well the NMX8 works and how safe it is when compared to other similar automated insulin delivery systems that are already available.

You might be interested in this study if you have Type 1 diabetes, are already using an automated insulin delivery system, but your blood sugar levels (measured by HbA1c) are still higher than recommended. The study aims to find out if the NMX8 system can help more people achieve better blood sugar control, which is important for long-term health and preventing complications.

This research is important because it could lead to new and improved ways for people with Type 1 diabetes to manage their condition. By finding better tools, we hope to improve daily life and overall health for many individuals in the future.

Key takeaways

Tests a new automated insulin system (NMX8) for Type 1 diabetes.
Aimed at adults not reaching blood sugar targets with current systems.
Compares NMX8 with other existing automated insulin delivery systems.
Involves a short initial period, followed by 6 months on NMX8 or current system, then 3 months on NMX8 for all.
Could lead to improved diabetes management options in the future.

Who may be eligible?

This study is for adults, aged 18 or over, who have had Type 1 diabetes for at least six months. You must already be using an approved automated insulin delivery system, such as MiniMed 780G, Control IQ, OmniPod 5, or CamAPS FX, and have been using it for at least three months.

Crucially, your current diabetes management means your HbA1c (a measure of average blood sugar over 2-3 months) is above 7.5%. This indicates you're not yet reaching your blood sugar target. You must also be able to use the study devices and attend all necessary training sessions.

There are also some reasons why you might not be able to join. These include certain untreated medical conditions like Addison's disease or severe gastroparesis, or if you're taking any diabetes medications other than insulin. You also can't have taken certain steroids recently or have severe kidney problems.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have Type 1 diabetes and have had it for at least 6 months?
Are you currently using an automated insulin delivery system (like MiniMed 780G, Control IQ, OmniPod 5, or CamAPS FX) and have been for at least 3 months?
Is your HbA1c level currently above 7.5% (meaning your blood sugars are higher than desired)?
Are you able to attend all study appointments and training sessions?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve three main stages over about 9 months. First, for three weeks, you'll continue your usual diabetes treatment, but you'll also wear a small, extra sensor (called a Simplera Sensor) that quietly collects your blood sugar information without showing it to you. This helps us understand your baseline.

Next, for six months, you'll be randomly assigned to one of two groups. One group will start using the new NMX8 system. The other group will continue using their current automated insulin delivery system. If you're in the group continuing your current treatment, you'll have two more 3-week periods at three and six months where you'll wear the extra Simplera Sensor again.

Finally, for a further three months, everyone in the study will have the opportunity to use the new NMX8 system. Throughout the study, you'll have training sessions to learn how to use the devices and will have regular check-ins with the study team. You'll need to be able to switch to specific types of insulin that work with the study pump.

Potential risks and benefits

Participating in this study might offer you benefits such as potentially improving your blood sugar control or gaining early access to a new diabetes management system. There's also the chance you could help advance understanding of Type 1 diabetes. However, all medical devices carry some risks, such as skin irritation from sensors, or the possibility of blood sugar highs or lows, though the study team will provide training and support. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Centre Hospitalier Universitaire de Caen
Verified postcode
Caen, France
Hôpital Michallon - CHU Grenoble
Verified postcode
Grenoble, France
Hospices Civils de Lyon (DIAB-e CARE)
Verified postcode
Lyon, France
CHU de Nîmes - Hôpital Universitaire Caremeau
Verified postcode
Nîmes, France
Hopital Lariboisiere & Fernand-Widal
Verified postcode
Paris, France
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Verified postcode
Bad Oeynhausen, Germany
Zentrum für digitale Diabetologie Hamburg
Verified postcode
Hamburg, Germany
Die Praxisgemeinschaft für Endokrinologie und Diabetes
Verified postcode
Rostock, Germany
Policlinico Sant' Orsola - Malpighi
Verified postcode
Bologna, Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Verified postcode
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Verified postcode
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore
Verified postcode
Roma, Italy

Common questions

What is an 'Automated Insulin Delivery' (AID) system?

An AID system, sometimes called an 'artificial pancreas,' is a special pump and sensor combination that works together to automatically adjust your insulin doses based on your current blood sugar levels.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past two to three months. It's a key indicator of how well your diabetes is being managed.

Will I know if I'm getting the new NMX8 system?

Yes, during the main six-month 'study phase,' you will know whether you are using the NMX8 system or continuing with your current automated insulin delivery system.

What happens after the study ends?

After the study's continuation phase, the use of the NMX8 system will depend on its availability and approval. The study team can provide more specific details on what happens for you individually.

Will I have to pay for anything?

No, all study-related devices, visits, and assessments will be provided at no cost to you. Any specific reimbursements for travel, etc., would be discussed by the study site.

How to find out more

Jessica Cellot

jessica.cellot@medtronic.com +393477668604 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.