Type 1 Diabetes (T1D)ELEVATENCT07401901
Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes
A study testing NMX8 System - Treatment arm and AID Therapy in people with Type 1 Diabetes (T1D), run by Medtronic MiniMed, Inc. at 21 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- NMX8 System - Treatment arm and AID Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 15 Oct 2026to 29 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol.
- Subject is willing and able to provide written informed consent.
Who cannot join
- 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.
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- 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.
- 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.
- History of 2 or more DKA events in the last 3 months before screening.
- Is on "DIY" therapy at the time of the screening or at least 3 months before the screening.
- 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.
- 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.
- Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- Is part of the research staff involved with the study.
- Is legally incompetent, illiterate or vulnerable person.
Trial locations and contacts
21 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 6 countries
France5 sites
Centre Hospitalier Universitaire de Caen
Caen
Hôpital Michallon - CHU Grenoble
Grenoble
Hospices Civils de Lyon (DIAB-e CARE)
Lyon
CHU de Nîmes - Hôpital Universitaire Caremeau
Nîmes
Hopital Lariboisiere & Fernand-Widal
Paris
Italy4 sites
Policlinico Sant' Orsola - Malpighi
Bologna
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan
Azienda Ospedaliera Universitaria Federico II
Naples
Fondazione Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore
Roma
Germany3 sites
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen
Zentrum für digitale Diabetologie Hamburg
Hamburg
Die Praxisgemeinschaft für Endokrinologie und Diabetes
Rostock
Netherlands3 sites
ZGT Almelo
Almelo
Amsterdam University Medical Center (Amsterdam UMC)
Amsterdam
Maastricht University Medical Center (UMC)
Maastricht
Spain3 sites
Hospital Universitari Clínic de Barcelona
Barcelona
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Paz
Madrid
United Kingdom3 sites
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge
Leicester General Hospital
Leicester
Manchester University NHS Foundation Trust - Manchester Royal Infirmary
Manchester
About this study
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.
Read the detailed description
ELEVATE is a pre-market, interventional, prospective, open-label, multi-center, randomized controlled study that consists of three phases: run-in, study and continuation phase.
Run-in: the purpose of this phase is to collect 3 weeks of blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current therapy (baseline assessment). All subjects will use an additional blinded Simplera Sensor to collect blinded CGM data.
Study Phase: during the 6-month of study phase subjects will either start using the NMX8 system (Treatment arm) or will continue to use their current AID therapy (Control arm). Subjects in the Control arm will undergo 3 weeks of blinded CGM data collection via Simplera Sensor at 3 and 6 months.
Continuation Phase: during the 3-month of continuation phase all subjects will use the NMX8 system.
Approximately 230 subjects will be enrolled in the study up to approximately 22 investigational centers in EMEA.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- NMX8 System - Treatment arm, AID Therapy, NMX8 System - Control Arm
- Keywords
- Automated insulin delivery (AID); Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Helping Behavior, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMX8 System - Treatment armDevice
Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).
AID TherapyDevice
Subjects will continue to use their current AID therapy during the study phase (6-month).
NMX8 System - Control ArmDevice
Subjects start using the NMX8 system during the continuation phases (3-month).
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (NMX8 system) | Experimental | Subjects randomized to the Treatment group will use the MiniMed NMX8 system Receives: Device: NMX8 System - Treatment arm |
| Control arm (AID Therapy) | Active comparator | Subjects randomized to the Control group will continue to use their current AID therapy during the study phase for 6-month. During the continuation phase, subjects in the Control group will use the NMX8 system for 3-month. Receives: Device: AID Therapy; Device: NMX8 System - Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time that the sensor glucose (SG) measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase .
The endpoint will be assessed for non-inferiority.
Measured: End of 6-month study phase
Secondary outcomes (3)
Secondary Endpoint 1
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase.
The endpoint will be assessed for non-inferiority.
Measured: End of 6-month study phase.
Secondary Endpoint 2
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase.
The endpoint will be assessed for superiority.
Measured: End of 6-month study phase.
Secondary Endpoints 3
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time spent in target range 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase.
The Endpoint will be assessed for superiority.
Measured: End of 6-month study phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Oct 2026 (estimated)
- Primary completion4 Dec 2027 (estimated)
- Study completion29 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Ohad Cohen, MD, Study chair, Medtronic MiniMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401901
- Sponsor's protocol ID
- CIP353
- Acronym
- ELEVATE
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07401901
- Acronym / sponsor ID
- ELEVATE / CIP353
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Automated insulin delivery (AID); Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 4 Dec 2027 (estimated)
- Study completion
- 29 Mar 2028 (estimated)
- First posted
- 11 Feb 2026 (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.
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.
Detailed description
ELEVATE is a pre-market, interventional, prospective, open-label, multi-center, randomized controlled study that consists of three phases: run-in, study and continuation phase.
Run-in: the purpose of this phase is to collect 3 weeks of blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current therapy (baseline assessment). All subjects will use an additional blinded Simplera Sensor to collect blinded CGM data.
Study Phase: during the 6-month of study phase subjects will either start using the NMX8 system (Treatment arm) or will continue to use their current AID therapy (Control arm). Subjects in the Control arm will undergo 3 weeks of blinded CGM data collection via Simplera Sensor at 3 and 6 months.
Continuation Phase: during the 3-month of continuation phase all subjects will use the NMX8 system.
Approximately 230 subjects will be enrolled in the study up to approximately 22 investigational centers in EMEA.
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 system) | Experimental | Device: NMX8 System - Treatment armSubjects randomized to the Treatment group will use the MiniMed NMX8 system |
| Control arm (AID Therapy) | Active comparator | Device: AID Therapy, Device: NMX8 System - Control ArmSubjects randomized to the Control group will continue to use their current AID therapy during the study phase for 6-month. During the continuation phase, subjects in the Control group will use the NMX8 system for 3-month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
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 |
|---|---|---|
| NMX8 System - Treatment armSubjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month). | Device | Treatment arm (NMX8 system) |
| AID TherapySubjects will continue to use their current AID therapy during the study phase (6-month). | Device | Control arm (AID Therapy) |
| NMX8 System - Control ArmSubjects start using the NMX8 system during the continuation phases (3-month). | Device | Control arm (AID Therapy) |
Primary outcome
Primary Endpoint
Time frame: End of 6-month study phase
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time that the sensor glucose (SG) measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase . The endpoint will be assessed for non-inferiority.
3 secondary outcomes
Secondary Endpoint 1
Time frame: End of 6-month study phase.
Secondary Endpoint 2
Time frame: End of 6-month study phase.
Secondary Endpoints 3
Time frame: End of 6-month 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 28 Apr 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.
Prof. Ohad Cohen, MD study chair
Medtronic MiniMed, Inc.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMX8 System - Treatment arm and AID Therapy in people with Type 1 Diabetes (T1D), run by Medtronic MiniMed, Inc. at 21 sites in 6 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 10 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Italy, Germany, Netherlands, Spain and 1 more country. 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 Jessica Cellot (+393477668604, jessica.cellot@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: End of 6-month 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 28 Apr 2026.