GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Purpose
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 called Disposable Sensor 5 in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Patients will use their current therapy while also wearing the DS5 for up to 40 days. During this time, they will complete a meal and exercise log. Patients will then be put into one of three groups by a computer by chance and given the NMX8 pump to use for 90 days. During this time, patients will either bolus or not bolus for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if patients like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.
Conditions
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
Eligibility
- Eligible Ages
- Between 7 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age at time of screening according to diabetes type: 1. T1D: Age 7-85 years 2. T2D: Age 18-85 years 2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below: 1. T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 2. T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. Is willing to provide informed consent/assent for participation. 4. Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials. 5. Is willing to wear the system continuously throughout the study. 6. Has a retinal eye examination prior to enrollment (if needed) per guidelines by the local professional society/hospital guidelines according to age, duration of diabetes and type of diabetes. Entry into the study is permitted at the investigators' discretion, depending on their interpretation of the findings. 7. Is willing to upload study pump data via an app or computer. 8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study: 1. Humalog™* (insulin lispro injection) 2. NovoLog™*/NovoRapid™* (insulin aspart solution for injection) 3. Admelog™* (insulin lispro injection) 4. Merilog™* (insulin aspart) 5. Authorized generic insulin aspart 6. Authorized generic insulin lispro
Exclusion Criteria
- Unable to consent due to a mental or intellectual disability. 2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening: 1. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization) 2. Coma or 3. Seizures 3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit. 4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit. 5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 6. Currently pregnant or planning to become pregnant during the time period of study participation 1. A negative pregnancy test will be required for all females of child-bearing potential prior to enrollment 2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable 7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated. 8. Has diagnosis of adrenal insufficiency. 9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit. 10. T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1), in the 8 weeks prior to screening. 1. Participants who have stopped using metformin and/or GLP-1 have done so at least 6 weeks prior to screening. 2. Participants currently taking metformin and/or GLP-1 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study. 11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1, Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening. 1. Participants who have stopped using metformin, GLP-1 or SLT-2 have done so at least 6 weeks prior to screening. 2. Participants currently taking metformin, GLP-1 or SGLT-2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study 12. Is using sulfonylureas and meglitinides, e.g. repaglinide 13. Is using inhalable insulin in the 8 weeks prior to screening. 14. Is using hydroxyurea at time of screening or plans to use it during the study 15. 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. 16. Is, at the discretion of the investigator, abusing drugs or alcohol. 17. Is, in the opinion of the investigator, not able to perform all study procedures safely. 18. Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator. 19. Has elective surgery planned that requires general anesthesia during the course of the study. 20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening. 21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation. 22. Is diagnosed with current eating disorder such as anorexia or bulimia. 23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c 24. Is on dialysis. 25. Has an estimated Glomerular Filtration Rate (eGFR) <30. 26. Has celiac disease that is not adequately treated as determined by the investigator. 27. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. 28. Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. 29. Is a member of the research staff involved with the study. 30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 - No meal bolus administration |
Patients will be asked not to bolus for any of their meals while using the NMX8 pump. |
|
|
Experimental Arm 2 - Meal bolus administration at all meals |
Patients will be asked to bolus for all of their meals while using the NMX8 pump. |
|
|
Experimental Arm 3 - Meal bolus administration at will |
Patients are free to bolus or not bolus for their meals as they wish using NMX8 pump. |
|
Recruiting Locations
Medical Investigations
Little Rock 4119403, Arkansas 4099753 72211
Little Rock 4119403, Arkansas 4099753 72211
Headlands Research California, LLC
Escondido 5346827, California 5332921 92025
Escondido 5346827, California 5332921 92025
Sansum Diabetes Research Institute
Goleta 5352963, California 5332921 93111
Goleta 5352963, California 5332921 93111
Loma Linda University Medical Center
Loma Linda 5367696, California 5332921 92354
Loma Linda 5367696, California 5332921 92354
Sutter Institute for Medical Research
Sacramento 5389489, California 5332921 95821
Sacramento 5389489, California 5332921 95821
Rady Children's Hospital - San Diego
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo 5392423, California 5332921 94401
San Mateo 5392423, California 5332921 94401
Stanford University Medical Center
Stanford 5398563, California 5332921 94304
Stanford 5398563, California 5332921 94304
Barbara Davis Center for Childhood Diabetes
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Barbara Davis Center for Childhood Diabetes
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06511
New Haven 4839366, Connecticut 4831725 06511
USF Diabetes and Endocrinology Center
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30303
Atlanta 4180439, Georgia 4197000 30303
Atlanta Diabetes Associates
Atlanta 4180439, Georgia 4197000 30318
Atlanta 4180439, Georgia 4197000 30318
Endocrine Research Solutions
Roswell 4219934, Georgia 4197000 30076
Roswell 4219934, Georgia 4197000 30076
Rocky Mountain Clinical Research
Idaho Falls 5596475, Idaho 5596512 83404
Idaho Falls 5596475, Idaho 5596512 83404
Northwestern University
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Indiana University Health Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
Iowa Diabetes and Endocrinology Center
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
International Diabetes Center
Minneapolis 5037649, Minnesota 5037779 55416
Minneapolis 5037649, Minnesota 5037779 55416
Bryan Physician Network
Lincoln 5072006, Nebraska 5073708 68510
Lincoln 5072006, Nebraska 5073708 68510
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Omaha 5074472, Nebraska 5073708 68198
NYC Research Inc
Long Island City 5125125, New York 5128638 11106
Long Island City 5125125, New York 5128638 11106
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
Revival Research Institute
Denton 4685907, Texas 4736286 76210
Denton 4685907, Texas 4736286 76210
Tekton Research
McKinney 4710178, Texas 4736286 75069
McKinney 4710178, Texas 4736286 75069
Rainier Clinical Research Center
Renton 5808189, Washington 5815135 98057
Renton 5808189, Washington 5815135 98057
Seattle Children's
Seattle 5809844, Washington 5815135 98105
Seattle 5809844, Washington 5815135 98105
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Diabetes