[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07521475":3,"trial-entities:NCT07521475":496,"trial-summary:NCT07521475":499},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":51,"secondary_outcomes":56,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":100,"locations":103,"central_contacts":486,"overall_officials":493,"references":494,"see_also_links":495},"NCT07521475","EVOLVE","Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes","EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes","RECRUITING","2027-09-23","2026-07","2026-08-03","2026-04-30","Insulet Corporation","INDUSTRY",true,"A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal\u002Fbolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks",null,[19],"Type 2 Diabetes Mellitus",[21,22,23,24,25,26,27],"Automated Insulin Delivery","T2D","Type 2 Diabetes","Omnipod","AID","Fully closed loop","FCL","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},350,"ESTIMATED",[36,44],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DEVICE","Device: Omnipod M System with study CGM","The Omnipod M system with the study CGM",[41],"Intervention group - Omnipod M",[43],"Omnipod M System",{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":49},"Standard Therapy plus study CGM","Standard therapy is continuation of pre-study insulin regimen and study CGM.",[48],"Control group - Pre-study insulin regimen",[50],"Control group",[52],{"measure":53,"description":54,"timeFrame":55},"HbA1c","Change in HbA1c (%) from baseline between the intervention and control groups","15 and 26 weeks",[57,60,63,66,69,72,75,78,81,84,86],{"measure":58,"description":59,"timeFrame":55},"Mean glucose","Change in mean CGM glucose mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":61,"description":62,"timeFrame":55},"Time in Range 70-180 mg\u002FdL","Change in CGM percent time 70-180 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":64,"description":65,"timeFrame":55},"Time > 180 mg\u002FdL","Change in CGM percent time \\>180 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":67,"description":68,"timeFrame":55},"Time > 250 mg\u002FdL","Change in CGM percent time \\>250 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":70,"description":71,"timeFrame":55},"Time in Range 70-140 mg\u002FdL","Change in CGM percent time 70-140 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":73,"description":74,"timeFrame":55},"Prolonged hyperglycemia events per week","Change in number of prolonged hyperglycemia events (\\>90 minutes with a CGM glucose \\>250 mg\u002FdL within a 120 minute period) from baseline, compared between the intervention and control groups",{"measure":76,"description":77,"timeFrame":55},"Time \u003C70 mg\u002FdL","Change in CGM percent time \\\u003C70 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":79,"description":80,"timeFrame":55},"Time \u003C54 mg\u002FdL","Change in CGM percent time \\\u003C54 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":82,"description":83,"timeFrame":55},"Time >300 mg\u002FdL","Change in CGM percent time \\>300 mg\u002FdL from baseline, compared between the intervention and control groups",{"measure":85,"timeFrame":55},"Type 2 Diabetes Distress Assessment System (T2-DDAS)",{"measure":87,"description":88,"timeFrame":55},"Standard Deviation","Change in standard deviation from baseline, compared between the intervention and control groups","ALL","18 Years","75 Years",false,{"inclusion":94,"exclusion":98,"raw_text":99},[95,96,97],"Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin; or (2) basal insulin only (without bolus insulin).","Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime insulin dose per day, or a non-automated insulin pump","Inhaled insulin may be used in addition to or instead of mealtime injections pre-study and as part of the Control group 4. For basal only users, screening A1C ≥7.5% and \\\u003C14.0%. For basal bolus users (i.e., all others), screening A1C ≥6.0% and \\\u003C14.0%.",[],"Inclusion Criteria:\n\n1. Age at time of consent 18-75 years (inclusive)\n2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening\n3. On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months excluded) to initiating baseline CGM data collection.\n\n   * Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin; or (2) basal insulin only (without bolus insulin).\n   * Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime insulin dose per day, or a non-automated insulin pump\n   * Inhaled insulin may be used in addition to or instead of mealtime injections pre-study and as part of the Control group\n4. For basal only users, screening A1C ≥7.5% and \\\u003C14.0%. For basal bolus users (i.e., all others), screening A1C ≥6.0% and \\\u003C14.0%.\n\n   • A1C measurement within 28 days prior to enrollment is acceptable\n5. Willing to use only the following types of U-100 insulin while using the study pump: Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic\u002Fbiosimilar equivalents\n6. Willing to use only study-provided Libre 2 Plus or 3 Plus sensor during the study and not use another sensor\n7. Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n8. No anticipated need to newly initiate noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose lowering effect during the 26-week RCT phase. (Additions or changes in these medications will be permitted during the Extension Phase)\n9. If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose-lowering effect, prescribed dose has been stable for 6 weeks prior to baseline CGM collection; and there is not an anticipated need to increase the dose during the 26-week trial phase (dose reductions will be permitted for safety).\n10. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol\n11. Willing to wear the system, including Pods, continuously throughout the 26-week trial phase\n12. Willing and able to sign the Informed Consent Form (ICF)\n13. Able to read and understand English\n14. If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n1. Use of an automated insulin delivery pump within 3 months prior to screening\n2. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.\n3. Current or known history of coronary artery disease that is not stable with medical management in the opinion of the investigator, including unstable angina, despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening\n4. Any planned surgery during the study which could be considered major in the opinion of the Investigator\n5. History of more than 1 episode of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n6. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis\n7. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement\n8. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n9. Plans to receive blood transfusion over the course of the 26-week trial phase.\n10. Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).\n11. Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to baseline CGM collection or plans to take oral or injectable steroids during the 26-week trial phase.\n12. Participation in another clinical study using an investigational drug or device within prior 30 days or intends to participate in any other interventional study during the 26-week trial phase\n13. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n14. Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned",[101,102],"ADULT","OLDER_ADULT",[104,122,136,150,164,179,188,202,217,228,239,254,269,284,299,314,329,343,357,371,386,400,414,429,444,458,471],{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":109,"contacts":110,"geoPoint":119},"University of Southern California","Los Angeles","California","90022","United States",[111,116],{"name":112,"role":113,"phone":114,"email":115},"Martha Walker","CONTACT","323-362-1322","mawalker@usc.edu",{"name":117,"role":118},"Anne Peters","PRINCIPAL_INVESTIGATOR",{"lat":120,"lon":121},34.05223,-118.24368,{"facility":123,"status":8,"city":124,"state":107,"zip":125,"country":109,"contacts":126,"geoPoint":133},"HOAG","Newport Beach","92663",[127,131],{"name":128,"role":113,"phone":129,"email":130},"Brittany Dennis","949-764-6896","brittany.dennis@hoag.org",{"name":132,"role":118},"David Ahn",{"lat":134,"lon":135},33.61891,-117.92895,{"facility":137,"status":8,"city":138,"state":107,"zip":139,"country":109,"contacts":140,"geoPoint":147},"Sansum Diabetes Research Institute","Santa Barbara","93105",[141,145],{"name":142,"role":113,"phone":143,"email":144},"Maggie Shuiman","(805) 350-8941","mshuirman@sansum.org",{"name":146,"role":118},"Kristin Castorino",{"lat":148,"lon":149},34.42083,-119.69819,{"facility":151,"status":8,"city":152,"state":107,"zip":153,"country":109,"contacts":154,"geoPoint":161},"Touro University California","Vallejo","94592",[155,159],{"name":156,"role":113,"phone":157,"email":158},"Tess Calinawan","(707) 638-5969","mcalinaw@touro.edu",{"name":160,"role":118},"Jay Shubrook",{"lat":162,"lon":163},38.10409,-122.25664,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":109,"contacts":169,"geoPoint":176},"University of Colorado Denver","Denver","Colorado","80204",[170,174],{"name":171,"role":113,"phone":172,"email":173},"Cari Berget","(303) 742-8377","cari.berget@cuanschutz.edu",{"name":175,"role":118},"Erik Kramer",{"lat":177,"lon":178},39.73915,-104.9847,{"facility":180,"status":181,"city":182,"state":183,"zip":184,"country":109,"geoPoint":185},"University of South Florida","ACTIVE_NOT_RECRUITING","Tampa","Florida","33612",{"lat":186,"lon":187},27.94752,-82.45843,{"facility":189,"status":8,"city":190,"state":183,"zip":191,"country":109,"contacts":192,"geoPoint":199},"Metabolic Research Institute","West Palm Beach","33401",[193,197],{"name":194,"role":113,"phone":195,"email":196},"Amanda Calderon","(561) 802-3060","acalderon@metabolic-institute.com",{"name":198,"role":118},"Barry Horowitz",{"lat":200,"lon":201},26.71534,-80.05337,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":109,"contacts":207,"geoPoint":214},"EMORY","Atlanta","Georgia","30308",[208,212],{"name":209,"role":113,"phone":210,"email":211},"Laya Chadalawada","610-256-9201","lchadal@emory.edu",{"name":213,"role":118},"Georgia Davis",{"lat":215,"lon":216},33.749,-84.38798,{"facility":218,"status":8,"city":204,"state":205,"zip":219,"country":109,"contacts":220,"geoPoint":227},"Atlanta Diabetes Associates","30318",[221,225],{"name":222,"role":113,"phone":223,"email":224},"Amanda Maxson","(404) 355-4393","studyadmin@atlantadiabetes.com",{"name":226,"role":118},"Bruce Bode",{"lat":215,"lon":216},{"facility":229,"status":8,"city":230,"state":205,"zip":231,"country":109,"contacts":232},"Endocrine Research Solutions, Inc.","Rosewell","30076",[233,237],{"name":234,"role":113,"phone":235,"email":236},"Jessica Tapia","(678) 878-4750","jtapia.ers@gmail.com",{"name":238,"role":118},"John Reed",{"facility":240,"status":8,"city":241,"state":242,"zip":243,"country":109,"contacts":244,"geoPoint":251},"Rocky Mountain Diabetes","Idaho Falls","Idaho","83404",[245,249],{"name":246,"role":113,"phone":247,"email":248},"Joann Malone","(208) 528-9650","joann.malone@rmclinicalresearch.com",{"name":250,"role":118},"David Liljenquist",{"lat":252,"lon":253},43.46658,-112.03414,{"facility":255,"status":8,"city":256,"state":257,"zip":258,"country":109,"contacts":259,"geoPoint":266},"Northwestern University","Chicago","Illinois","60611",[260,264],{"name":261,"role":113,"phone":262,"email":263},"Evelyn Fronczyk","312-908-9002","evelyn.guevara@northwestern.edu",{"name":265,"role":118},"Grazia Aleppo",{"lat":267,"lon":268},41.85003,-87.65005,{"facility":270,"status":8,"city":271,"state":272,"zip":273,"country":109,"contacts":274,"geoPoint":281},"Indiana University","Bloomington","Indiana","47405",[275,279],{"name":276,"role":113,"phone":277,"email":278},"Kathy Bohanan","(317) 278-0651","kkremer@iu.edu",{"name":280,"role":118},"Viral Shah",{"lat":282,"lon":283},39.16533,-86.52639,{"facility":285,"status":8,"city":286,"state":287,"zip":288,"country":109,"contacts":289,"geoPoint":296},"Joslin Diabetes Center","Boston","Massachusetts","02215",[290,294],{"name":291,"role":113,"phone":292,"email":293},"Louise Ambler-Osborn","617-975-8206","louise.ambler-osborn@joslin.harvard.edu",{"name":295,"role":118},"Lori Laffel",{"lat":297,"lon":298},42.35843,-71.05977,{"facility":300,"status":8,"city":301,"state":302,"zip":303,"country":109,"contacts":304,"geoPoint":311},"Henry Ford Health","Detroit","Michigan","48202",[305,309],{"name":306,"role":113,"phone":307,"email":308},"Lydia Oehring","(313) 916-3906","loehrin1@hfhs.org",{"name":310,"role":118},"Davida Kruger",{"lat":312,"lon":313},42.33143,-83.04575,{"facility":315,"status":8,"city":316,"state":317,"zip":318,"country":109,"contacts":319,"geoPoint":326},"International Diabetes Center","Minneapolis","Minnesota","55416",[320,324],{"name":321,"role":113,"phone":322,"email":323},"Landon Haber","952-993-3042","landon.haber@healthpartners.com",{"name":325,"role":118},"Anders Carlson",{"lat":327,"lon":328},44.97997,-93.26384,{"facility":330,"status":8,"city":331,"state":317,"zip":332,"country":109,"contacts":333,"geoPoint":340},"Mayo Clinic","Rochester","55902",[334,338],{"name":335,"role":113,"phone":336,"email":337},"Shafaq Rizvi","507-255-2914","miller.chloe@mayo.edu",{"name":339,"role":118},"Yogish Kudva",{"lat":341,"lon":342},44.02163,-92.4699,{"facility":344,"status":8,"city":345,"state":345,"zip":346,"country":109,"contacts":347,"geoPoint":354},"The Mount Sinai Hospital","New York","10029",[348,352],{"name":349,"role":113,"phone":350,"email":351},"Sophie Baum","(212) 241-4301","sophie.baum@mssm.edu",{"name":353,"role":118},"Carol Levy",{"lat":355,"lon":356},40.71427,-74.00597,{"facility":358,"status":8,"city":359,"state":345,"zip":360,"country":109,"contacts":361,"geoPoint":368},"SUNY Syracuse","Syracuse","13210",[362,366],{"name":363,"role":113,"phone":364,"email":365},"Suzan Bzdick","(315) 464-9006","BzdickS@upstate.edu",{"name":367,"role":118},"Malek El Muayed",{"lat":369,"lon":370},43.04812,-76.14742,{"facility":372,"status":8,"city":373,"state":374,"zip":375,"country":109,"contacts":376,"geoPoint":383},"Mountain Area Health Education Center","Asheville","North Carolina","28803",[377,381],{"name":378,"role":113,"phone":379,"email":380},"Michelle Chapman","(828) 708-8281","michelle.chapman@mahec.net",{"name":382,"role":118},"Casey Wells",{"lat":384,"lon":385},35.60095,-82.55402,{"facility":387,"status":8,"city":388,"state":374,"zip":389,"country":109,"contacts":390,"geoPoint":397},"Accellacare","Wilmington","28401",[391,395],{"name":392,"role":113,"phone":393,"email":394},"Cara Insco","910-799-5500","cara.insco@accellacare.com",{"name":396,"role":118},"John Parker",{"lat":398,"lon":399},34.23556,-77.94604,{"facility":401,"status":8,"city":402,"state":403,"zip":404,"country":109,"contacts":405,"geoPoint":411},"Oregon Health and Science University","Portland","Oregon","97239",[406,409],{"name":407,"role":113,"email":408},"Desiree Odgers","odgers@ohsu.edu",{"name":410,"role":118},"Rodica Busui",{"lat":412,"lon":413},45.52345,-122.67621,{"facility":415,"status":8,"city":416,"state":417,"zip":418,"country":109,"contacts":419,"geoPoint":426},"University of Diabetes and Endocrine Consultants","Chattanooga","Tennessee","37411",[420,424],{"name":421,"role":113,"phone":422,"email":423},"Kaitlyn Harden","(423) 265-3561","kharden@drhuffman.com",{"name":425,"role":118},"David Huffman",{"lat":427,"lon":428},35.04563,-85.30968,{"facility":430,"status":8,"city":431,"state":432,"zip":433,"country":109,"contacts":434,"geoPoint":441},"Texas Diabetes and Endocrinology","Austin","Texas","78749",[435,439],{"name":436,"role":113,"phone":437,"email":438},"Jennifer Perez","(512) 334-3505","jperez@tderesearch.com",{"name":440,"role":118},"Thomas Blevins",{"lat":442,"lon":443},30.26715,-97.74306,{"facility":445,"status":8,"city":446,"state":432,"zip":447,"country":109,"contacts":448,"geoPoint":455},"Tekton Research","McKinney","75072",[449,453],{"name":450,"role":113,"phone":451,"email":452},"Idolina Garcia","(214) 831-7137","idolina.garcia@tektonresearch.com",{"name":454,"role":118},"Pablo Mora",{"lat":456,"lon":457},33.19762,-96.61527,{"facility":445,"status":8,"city":459,"state":432,"zip":460,"country":109,"contacts":461,"geoPoint":468},"San Antonio","78258",[462,466],{"name":463,"role":113,"phone":464,"email":465},"Sharon Jones","(210) 996-2600","sharon.jones@tektonresearch.com",{"name":467,"role":118},"Jara McDonald",{"lat":469,"lon":470},29.42412,-98.49363,{"facility":472,"status":8,"city":473,"state":474,"zip":475,"country":109,"contacts":476,"geoPoint":483},"Riverside Family Medicine Residency Program","Newport News","Virginia","23601",[477,481],{"name":478,"role":113,"phone":479,"email":480},"Elizabeth Eckhart","(757) 534-5374","elizabeth.eckhart@rivhs.com",{"name":482,"role":118},"Beth Klug",{"lat":484,"lon":485},36.98038,-76.42975,[487,491],{"name":488,"role":113,"phone":489,"email":490},"Trang Ly, MBBS, PhD","978-600-7000","APClinical@insulet.com",{"name":492,"role":113,"phone":489,"email":490},"Bonnie Dumais, RN",[],[],[],{"nct_id":4,"conditions":497,"biomarkers":498},[19],[],{"nct_id":4,"found":92,"summary":17,"prompt_version":17}]