Diabetes (Insulin-requiring, Type 1 or Type 2)NEXUSNCT07227805
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
A study testing NMX8 and 780G in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by Medtronic MiniMed, Inc. at 9 sites in 4 countries.
Trial summary
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2)
- What is being tested?
- NMX8 and 780G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 19 Jul 2026to 17 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is aged ≥2 years old at time of screening.
- 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.
- Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
- Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
- Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
- Willing to switch to approved insulin per insulin pump labeling.
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- 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.
- Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
- Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
- 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.
- For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.
Who cannot join
- Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
- 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).
- 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
- 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 active or severe retinopathy in the last 6 months before screening
- Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
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- Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- History of 2 or more DKA events in the last 3 months before screening.
- Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
- Is using hydroxyurea at time of screening or plans to use it during the study
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
- Women who are breastfeeding.
- 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.
- Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.
- Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
Belgium4 sites, 4 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp
Christophe De Block
- Recruiting
Cliniques Universitaires de Bruxelles - Hôpital Erasme
Brussels
Laurent Crenier
- Recruiting
UZ Leuven
Leuven
Pieter Gillard
- Recruiting
UZ Leuven
Leuven
Kristina Casteels
Denmark2 sites, 2 recruiting
- Recruiting
Steno Diabetes Center Aarhus
Aarhus
Rakel Fuglsang Johansen
- Recruiting
Steno Diabetes Center Copenhagen
Herlev
Kirsten Noergaard
Israel2 sites, 2 recruiting
- Recruiting
Sheba Medical Center, Edmond and Lily Safra Children's Hospital
Ramat Gan
Noah Gruber
- Recruiting
Sheba Medical Center
Ramat Gan
Amir Tirosh
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana
Klemen Dovc
About this study
Official title: Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.
Read the detailed description
This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study.
The study consists of a run-in phase and a study phase.
Run-in Phase:
The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor.
At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm).
Study Phase:
During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.
- Being tested
- NMX8, 780G
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMX8Device
Subjects will start using the MiniMed™ NMX8 system for 12 weeks
780GDevice
Subjects will continue to use the MiniMed™ 780G for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (NMX8) | Experimental | Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system Receives: Device: NMX8 |
| Control arm (780G) | Active comparator | Subjects randomized to the Control arm will continue to use the MiniMed™ 780G. Receives: Device: 780G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The between-treatment (control arm with 780G system versus treatment arm with NMX8 system) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) with a non-inferiority testing.
Measured: During the 12-week study phase
Secondary outcomes (3)
Secondary Endpoint 1
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with a non-inferiority testing.
Measured: End of 12-week Study Phase
Secondary endpoint 2
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in % of Time spent in target range (70 to 180 mg/dL [3.9 - 10.0 mmol/L]) during the study phase with superiority test.
Measured: During the 12-week Study Phase
Secondary Endpoint 3
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with superiority testing.
Measured: End of the 12-week Study Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start19 Jul 2026
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pr. Ohad Cohen, MD, Study chair, Medtronic MiniMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227805
- Sponsor's protocol ID
- CIP352
- Acronym
- NEXUS
- Status last verified
- Jul 2026
- First submitted
- 11 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes
- ClinicalTrials.gov ID
- NCT07227805
- Acronym / sponsor ID
- NEXUS / CIP352
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2026 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.
Detailed description
This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study.
The study consists of a run-in phase and a study phase.
Run-in Phase:
The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor.
At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm).
Study Phase:
During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (NMX8) | Experimental | Device: NMX8Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system |
| Control arm (780G) | Active comparator | Device: 780GSubjects randomized to the Control arm will continue to use the MiniMed™ 780G. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Is aged ≥2 years old at time of screening.
- 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.
- Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
- Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
- Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
Key exclusion criteria (16 listed)
- Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
- 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).
- 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
- 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 active or severe retinopathy in the last 6 months before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMX8Subjects will start using the MiniMed™ NMX8 system for 12 weeks | Device | Treatment arm (NMX8) |
| 780GSubjects will continue to use the MiniMed™ 780G for 12 weeks | Device | Control arm (780G) |
Primary outcome
Primary Endpoint
Time frame: During the 12-week study phase
The between-treatment (control arm with 780G system versus treatment arm with NMX8 system) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) with a non-inferiority testing.
3 secondary outcomes
Secondary Endpoint 1
Time frame: End of 12-week Study Phase
Secondary endpoint 2
Time frame: During the 12-week Study Phase
Secondary Endpoint 3
Time frame: End of the 12-week Study Phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pr. Ohad Cohen, MD study chair
Medtronic MiniMed, Inc.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMX8 and 780G in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by Medtronic MiniMed, Inc. at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Denmark, Israel, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renée Tillie, PhD (+31627363854, renee.tillie@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: During the 12-week study phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.