MiniMed NMX8-AID System for Diabetes

Not yet recruiting at 30 trial locations

Overseen By Thomas Troub

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

Must be taking: Insulin lispro, Insulin aspart

Must not be taking: Sulfonylureas, Meglitinides, Inhalable insulin, Glucocorticoids

Disqualifiers: Severe hypoglycemia, DKA, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of the MiniMed™ NMX8-AID System, a new insulin pump, when used with the Disposable Sensor 5 continuous glucose monitor for people with diabetes. Participants will be randomly assigned to one of three groups to test different methods of using the pump with meals. Individuals with Type 1 diabetes (for at least 6 months) or Type 2 diabetes (insulin-dependent for over a year) who are willing to wear the devices and log meals and exercise may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

Do I have to stop taking my current medications for the trial?

You may need to stop certain medications before joining the trial. If you are taking non-insulin diabetes medications, you must have stopped them at least 6 weeks before the trial, except for metformin, GLP-1, and SGLT-2, which you can continue if the dose is steady. Check with the trial team for specific guidance on your medications.

What prior data suggests that the MiniMed NMX8-AID System is safe for people with diabetes?

Research has shown that the MiniMed NMX8-AID System, a new insulin pump, is generally safe to use. Previous studies found it works well with a continuous glucose monitoring sensor, such as the Disposable Sensor 5. Data from these studies did not reveal any major safety concerns. Users of the system did not report any serious side effects, indicating it is well-tolerated for managing diabetes. However, as with any medical device, some minor issues might occur. Discussing any concerns with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MiniMed™ NMX8-AID System because it offers a flexible approach to insulin delivery for diabetes management. Unlike traditional insulin pumps that often require precise meal bolus administration, this system includes options for users to either skip bolusing, bolus with every meal, or bolus as they wish. This flexibility allows for more personalized diabetes management, which can significantly enhance a patient's quality of life. By adapting to individual needs and preferences, the NMX8-AID System could potentially improve adherence and overall glucose control, making it a promising advancement in diabetes care.

What evidence suggests that the MiniMed NMX8-AID System is effective for diabetes?

Studies have shown that the MiniMed™ NMX8-AID System can effectively manage blood sugar levels in people with diabetes. This trial will evaluate different approaches to meal bolus administration using the NMX8 pump. Research indicates that similar systems, like the MM780G, improve blood sugar control by automatically adjusting insulin delivery with advanced technology. This capability helps maintain stable blood sugar levels throughout the day. Initial findings suggest that users of these systems experience better blood sugar control, spending more time with their levels in the target range. The system has succeeded in real-world settings, demonstrating its potential to enhance diabetes management. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children and adults with Type 1 diabetes aged 7-85, and adults with Type 2 diabetes aged 18-85. Participants must be currently managing their diabetes. They cannot join if they have other medical conditions that could interfere with the study or if they're unable to follow the study procedures.

Inclusion Criteria

Is willing to provide informed consent/assent for participation

Is willing to wear the system continuously throughout the study

Is willing to upload study pump data via an app or computer

Exclusion Criteria

Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study

Is, at the discretion of the investigator, abusing drugs or alcohol

I have had 2 or more severe low blood sugar episodes in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Therapy and Monitoring

Participants use their current therapy while wearing the DS5 sensor and complete a meal and exercise log

Up to 40 days

Randomized Treatment

Participants are randomized into one of three groups to use the NMX8 pump for 90 days, with varying meal bolus instructions

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Continued Access Period (optional)

Participants may opt to continue using the NMX8 pump after the study

What Are the Treatments Tested in This Trial?

Interventions

• MiniMed™ NMX8-AID System

Trial Overview The trial tests a new insulin pump system called MiniMed™ NMX8-AID used alongside a glucose monitoring sensor DS5™. Participants will initially use their current therapy plus DS5 for up to 40 days, then randomly use the NMX8 pump for 90 days while logging meals and exercise.

How Is the Trial Designed?

Group I: Arm 3 - Meal bolus administration at will Experimental Treatment 1 Intervention

Patients are free to bolus or not bolus for their meals as they wish using NMX8 pump.

Group II: Arm 2 - Meal bolus administration at all meals Experimental Treatment 1 Intervention

Patients will be asked to bolus for all of their meals while using the NMX8 pump.

Group III: Arm 1 - No meal bolus administration Experimental Treatment 1 Intervention

Patients will be asked not to bolus for any of their meals while using the NMX8 pump.

Who Is Running the Clinical Trial?

Medtronic Diabetes

Lead Sponsor

Trials

73

Recruited

11,800+

Geoff Martha

Medtronic Diabetes

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kweli Thompson

Medtronic Diabetes

Chief Medical Officer since 2022

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227805?term=diabetes

Study Details | NCT07227805 | Evaluation of the Safety ... This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07228117?aggFilters=status%3A%2Cphase%3A

Safety Evaluation of the MiniMed™ NMX8-AID System in ... The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor ...

3. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12623001076662p

NMX-AID The purpose of this research study is to demonstrate feasibility and to generate initial data to evaluate safety, user acceptance and system efficacy of the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12544667/

SAT-625 Democratization of Glycemic Outcomes in People ... Conclusion: The data show similar glycemic outcomes in real-world MM780G users across the world suggesting the algorithmic approach employed by ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07227805

NMX8 and 780G in Diabetes (Insulin-requiring, Type 1 or ... This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 ...

6. trial.medpath.com trial.medpath.com/clinical-trial/c9845836e3138dcf/nct07227805-medtronic-insulin-delivery-system-diabetes

Evaluation of the Safety and Performance of the Novel ... This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 ...

7. medtronicdiabetes.com medtronicdiabetes.com/important-safety-information

Important Safety Information Important safety information. Indications, contraindications, warnings and precautions. All Medtronic MiniMed™ devices and associated ...