[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07228117":3,"trial-entities:NCT07228117":325,"trial-summary:NCT07228117":328},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":70,"central_contacts":321,"overall_officials":322,"references":323,"see_also_links":324},"NCT07228117","CIP351","GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes","ACTIVE_NOT_RECRUITING","2027-01","2026-09","2026-09-02","2026-02-02","Medtronic MiniMed, Inc.","INDUSTRY",true,"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\u002FSimplera Sync 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. Participants will use their current therapy while also wearing the DS5\u002FSimplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will 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 participants 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.",null,[18,19],"Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus",[],"INTERVENTIONAL","OTHER",[24],"NA",{"count":26,"type":27},389,"ACTUAL",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","MiniMed™ NMX8-AID System with DS5™\u002FSimplera Sync™","Patients will be provided with the NMX8 system with DS5\u002FSimplera Sync CGM.",[34,35,36],"Arm 1 - No meal bolus administration","Arm 2 - Meal bolus administration at all meals","Arm 3 - Meal bolus administration at will",[38,42,45,48,51,54],{"measure":39,"description":40,"timeFrame":41},"Study Arm 1: Percent of Time in Range (TIR 70-180 mg\u002FdL)","Percent of time in range (TIR 70-180 mg\u002FdL) among subjects randomized to Study Arm 1. Descriptive only.","Throughout the study period, approximately 90 days.",{"measure":43,"description":44,"timeFrame":41},"Study Arm 1: Percent of Time in Hypoglycemia (\u003C 70 mg\u002FdL)","Percent of time in hypoglycemia (\\\u003C 70 mg\u002FdL) among subjects randomized to Study Arm 1. Descriptive only.",{"measure":46,"description":47,"timeFrame":41},"Study Arm 2: Percent of Time in Range (TIR 70-180 mg\u002FdL)","Percent of time in range (TIR 70-180 mg\u002FdL) among subjects randomized to Study Arm 2. Descriptive only.",{"measure":49,"description":50,"timeFrame":41},"Study Arm 2: Percent of Time in Hypoglycemia (\u003C 70 mg\u002FdL)","Percent of time in hypoglycemia (\\\u003C 70 mg\u002FdL) among subjects randomized to Study Arm 2. Descriptive only.",{"measure":52,"description":53,"timeFrame":41},"Study Arm 3: Percent of Time in Range (TIR 70-180 mg\u002FdL)","Percent of time in range (TIR 70-180 mg\u002FdL) among subjects randomized to Study Arm 3. Descriptive only.",{"measure":55,"description":56,"timeFrame":41},"Study Arm 3: Percent of Time in Hypoglycemia (\u003C 70 mg\u002FdL)","Percent of time in hypoglycemia (\\\u003C 70 mg\u002FdL) among subjects randomized to Study Arm 3. Descriptive only.",[],"ALL","7 Years","85 Years",false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Age at time of screening according to diabetes type:\n\n   1. T1D: Age 7-85 years\n   2. T2D: Age 18-85 years\n2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:\n\n   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.\n   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\n3. Is willing to provide informed consent\u002Fassent for participation.\n4. Subject or parent\u002Fcaregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.\n5. Is willing to wear the system continuously throughout the study.\n6. Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:\n\n   1. T1D adults (Age 18-85 years):\n\n      I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.\n   2. T2D adults (Age 18-85 years):\n\n      I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.\n   3. T1D pediatric (Age 7-17 years):\n\n   I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.\n\n   II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.\n\n   Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.\n7. Is willing to upload study pump data via an app or computer.\n8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:\n\n   1. Humalog™\\* (insulin lispro injection)\n   2. NovoLog™\\* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™\\*)\n   3. NovoRapid™\\* (insulin aspart solution for injection)\n   4. Admelog™\\* (insulin lispro injection)\n   5. Merilog™\\* (insulin aspart)\n   6. Fiasp™\\* (ultra-rapid-acting insulin aspart)\n   7. Lyumjev™\\* (ultra-rapid-acting insulin lispro)\n   8. Authorized generic insulin aspart\n   9. Authorized generic insulin lispro\n\nExclusion Criteria:\n\n1. Unable to consent due to a mental or intellectual disability.\n2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:\n\n   1. Medical assistance (i.e., Paramedics, Emergency Room \\[ER\\] or Hospitalization)\n   2. Coma or\n   3. Seizures\n3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.\n4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.\n5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n6. Currently pregnant or planning to become pregnant during the time period of study participation\n\n   1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening\n   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\n7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.\n8. Has diagnosis of adrenal insufficiency.\n9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.\n10. T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and\u002For Glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.\n\n    1. Participants who have stopped using metformin and\u002For GLP-1\u002FGIP have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin and\u002For GLP-1\u002FGIP must be on a steady dose and remain on the same dose during study participation until the end of the study period.\n    3. During continued access, starting\u002Fstopping the medication and\u002For modifying doses will be permitted.\n    4. Dose changes and reasons for changes will be documented throughout the study.\n11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 \u002FGIP containing medications (e.g., Mounjaro), DPP-4 Inhibitors, thiazolidinedione (TZD), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.\n\n    1. Participants who have stopped using metformin, GLP-1\u002FGIP, DPP-4 Inhibitors, TZD, or SGLT2 have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin, GLP-1\u002FGIP, DPP-4 Inhibitors, TZD, or SGLT2 must be on a steady dose and remain on the same dose during study participation, until the end of the study period.\n    3. During continued access, starting\u002Fstopping the medication and\u002For modifying doses will be permitted.\n    4. Dose changes and reasons for changes will be documented throughout the study\n12. Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.\n13. Is using inhalable insulin in the 8 weeks prior to screening.\n14. Is using hydroxyurea at time of screening or plans to use it during the study\n15. 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.\n16. Is, at the discretion of the investigator, abusing drugs or alcohol.\n17. Is, in the opinion of the investigator, not able to perform all study procedures safely.\n18. 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.\n19. Has elective surgery planned that requires general anesthesia during the course of the study.\n20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.\n21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.\n22. Is diagnosed with current eating disorder such as anorexia or bulimia.\n23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c\n24. Is on dialysis.\n25. Has an estimated Glomerular Filtration Rate (eGFR) \\\u003C30. For T1D subjects who are within the first 5 years after diagnosis, a new eGFR test is not required for screening; however, if an eGFR value taken during the first 5 years from diagnosis is available, and if it is \\\u003C30, the subject will be excluded.\n26. Has celiac disease that is not adequately treated as determined by the investigator.\n27. 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.\n28. 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.\n29. Is a member of the research staff involved with the study.\n30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and\u002For adult siblings).",[67,68,69],"CHILD","ADULT","OLDER_ADULT",[71,80,88,95,102,109,116,123,130,138,146,154,161,169,173,180,188,196,204,212,220,228,236,244,252,260,267,274,282,289,298,305,313],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"Medical Investigations","Little Rock","Arkansas","72211","United States",{"lat":78,"lon":79},34.74648,-92.28959,{"facility":81,"city":82,"state":83,"zip":84,"country":76,"geoPoint":85},"Headlands Research California, LLC","Escondido","California","92025",{"lat":86,"lon":87},33.11921,-117.08642,{"facility":89,"city":90,"state":83,"zip":91,"country":76,"geoPoint":92},"Sansum Diabetes Research Institute","Goleta","93111",{"lat":93,"lon":94},34.43583,-119.82764,{"facility":96,"city":97,"state":83,"zip":98,"country":76,"geoPoint":99},"Loma Linda University Medical Center","Loma Linda","92354",{"lat":100,"lon":101},34.04835,-117.26115,{"facility":103,"city":104,"state":83,"zip":105,"country":76,"geoPoint":106},"Sutter Institute for Medical Research","Sacramento","95821",{"lat":107,"lon":108},38.58157,-121.4944,{"facility":110,"city":111,"state":83,"zip":112,"country":76,"geoPoint":113},"University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes","San Francisco","94158",{"lat":114,"lon":115},37.77493,-122.41942,{"facility":117,"city":118,"state":83,"zip":119,"country":76,"geoPoint":120},"Mills-Peninsula Medical Center: Diabetes Research Institute","San Mateo","94401",{"lat":121,"lon":122},37.56299,-122.32553,{"facility":124,"city":125,"state":83,"zip":126,"country":76,"geoPoint":127},"Stanford University Medical Center","Stanford","94304",{"lat":128,"lon":129},37.42411,-122.16608,{"facility":131,"city":132,"state":133,"zip":134,"country":76,"geoPoint":135},"Barbara Davis Center for Childhood Diabetes","Aurora","Colorado","80045",{"lat":136,"lon":137},39.72943,-104.83192,{"facility":139,"city":140,"state":141,"zip":142,"country":76,"geoPoint":143},"Yale University School of Medicine","New Haven","Connecticut","06511",{"lat":144,"lon":145},41.30815,-72.92816,{"facility":147,"city":148,"state":149,"zip":150,"country":76,"geoPoint":151},"USF Diabetes and Endocrinology Center","Tampa","Florida","33612",{"lat":152,"lon":153},27.94752,-82.45843,{"facility":155,"city":156,"state":149,"zip":157,"country":76,"geoPoint":158},"Metabolic Research Institute","West Palm Beach","33401",{"lat":159,"lon":160},26.71534,-80.05337,{"facility":162,"city":163,"state":164,"zip":165,"country":76,"geoPoint":166},"Emory University School of Medicine","Atlanta","Georgia","30303",{"lat":167,"lon":168},33.749,-84.38798,{"facility":170,"city":163,"state":164,"zip":171,"country":76,"geoPoint":172},"Atlanta Diabetes Associates","30318",{"lat":167,"lon":168},{"facility":174,"city":175,"state":164,"zip":176,"country":76,"geoPoint":177},"Endocrine Research Solutions","Roswell","30076",{"lat":178,"lon":179},34.02316,-84.36159,{"facility":181,"city":182,"state":183,"zip":184,"country":76,"geoPoint":185},"Rocky Mountain Clinical Research","Idaho Falls","Idaho","83404",{"lat":186,"lon":187},43.46658,-112.03414,{"facility":189,"city":190,"state":191,"zip":192,"country":76,"geoPoint":193},"Northwestern University","Chicago","Illinois","60611",{"lat":194,"lon":195},41.85003,-87.65005,{"facility":197,"city":198,"state":199,"zip":200,"country":76,"geoPoint":201},"Indiana University Health Riley Hospital for Children","Indianapolis","Indiana","46202",{"lat":202,"lon":203},39.76838,-86.15804,{"facility":205,"city":206,"state":207,"zip":208,"country":76,"geoPoint":209},"Iowa Diabetes and Endocrinology Center","West Des Moines","Iowa","50266",{"lat":210,"lon":211},41.57721,-93.71133,{"facility":213,"city":214,"state":215,"zip":216,"country":76,"geoPoint":217},"Barry J. Reiner, MD LLC","Baltimore","Maryland","21229",{"lat":218,"lon":219},39.29038,-76.61219,{"facility":221,"city":222,"state":223,"zip":224,"country":76,"geoPoint":225},"International Diabetes Center","Minneapolis","Minnesota","55416",{"lat":226,"lon":227},44.97997,-93.26384,{"facility":229,"city":230,"state":231,"zip":232,"country":76,"geoPoint":233},"Bryan Physician Network","Lincoln","Nebraska","68510",{"lat":234,"lon":235},40.8,-96.66696,{"facility":237,"city":238,"state":239,"zip":240,"country":76,"geoPoint":241},"NYC Research Inc","Long Island City","New York","11106",{"lat":242,"lon":243},40.74482,-73.94875,{"facility":245,"city":246,"state":247,"zip":248,"country":76,"geoPoint":249},"University Diabetes and Endocrine Consultants","Chattanooga","Tennessee","37411",{"lat":250,"lon":251},35.04563,-85.30968,{"facility":253,"city":254,"state":255,"zip":256,"country":76,"geoPoint":257},"Texas Diabetes & Endocrinology","Austin","Texas","78731",{"lat":258,"lon":259},30.26715,-97.74306,{"facility":261,"city":262,"state":255,"zip":263,"country":76,"geoPoint":264},"Revival Research Institute","Denton","76210",{"lat":265,"lon":266},33.21484,-97.13307,{"facility":268,"city":269,"state":255,"zip":270,"country":76,"geoPoint":271},"Tekton Research","McKinney","75069",{"lat":272,"lon":273},33.19762,-96.61527,{"facility":275,"city":276,"state":277,"zip":278,"country":76,"geoPoint":279},"Rainier Clinical Research Center","Renton","Washington","98057",{"lat":280,"lon":281},47.48288,-122.21707,{"facility":283,"city":284,"state":277,"zip":285,"country":76,"geoPoint":286},"Seattle Children's","Seattle","98105",{"lat":287,"lon":288},47.60621,-122.33207,{"facility":290,"city":291,"state":292,"zip":293,"country":294,"geoPoint":295},"John Hunter Children's Hospital","New Lambton","New South Wales","2305","Australia",{"lat":296,"lon":297},-32.92838,151.7085,{"facility":299,"city":300,"state":292,"zip":301,"country":294,"geoPoint":302},"Royal North Shore Hospital","Sydney","2065",{"lat":303,"lon":304},-33.86785,151.20732,{"facility":306,"city":307,"state":308,"zip":309,"country":294,"geoPoint":310},"The Kids Research Institute Australia","Perth","Western Australia","6009",{"lat":311,"lon":312},-31.95224,115.8614,{"facility":314,"city":315,"zip":316,"country":317,"geoPoint":318},"University of Otago - Dunedin Hospital","Dunedin","9016","New Zealand",{"lat":319,"lon":320},-45.87416,170.50361,[],[],[],[],{"nct_id":4,"conditions":326,"biomarkers":327},[18,19],[],{"nct_id":4,"found":14,"summary":329,"prompt_version":339},{"design":330,"status":331,"heading":332,"summary":333,"follow_up":334,"word_count":335,"commitments":336,"compensation":337,"drugs_mentioned":338},"This is an interventional study with an estimated 400 participants. Participants will be randomly assigned to one of three groups after an initial observation period.","completed","GATEWAY: Safety of MiniMed™ NMX8-AID System for Diabetes","This study, called GATEWAY, is testing a new insulin pump system, the MiniMed™ NMX8-AID System, along with a continuous glucose monitor (CGM) called DS5™\u002FSimplera Sync™. The main goal is to see if this system is safe for people with diabetes. It includes individuals with Type 1 diabetes (ages 7-85) and Type 2 diabetes (ages 18-85). Participants will first wear the DS5\u002FSimplera sensor for up to 40 days while continuing their usual diabetes care. Then, they will use the NMX8 pump for about 90 days. Success will be measured by how much time participants spend with their blood sugar in a healthy range (70-180 mg\u002FdL) and how much time they spend with low blood sugar (below 70 mg\u002FdL). The current status of this study is unclear.","The primary endpoints for measuring blood sugar levels are throughout the study period, approximately 90 days.",125,"You would first use your current therapy while wearing the DS5\u002FSimplera sensor for up to 40 days, completing meal and exercise logs. Then, you would use the NMX8 pump for about 90 days, continuing to complete meal and exercise logs depending on your assigned group.","Not stated in the trial record.",[],"v2"]