[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541080":3},{"organization":4,"armGroups":7,"interventions":57,"overallOfficials":73,"centralContacts":85,"locations":96,"responsibleParty":237,"collaborators":241,"id":255,"slug":256,"hasResults":257,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":257,"sex":263,"minAge":264,"maxAge":265,"enrollmentInfo":266,"targetDuration":63,"studyType":269,"phases":270,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":99,"whyStopped":63,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8,14,18,23,29,33,37,41,45,49,53],{"label":9,"type":10,"description":11,"interventionNames":12},"current HCL non-user: HCL x 24 months","EXPERIMENTAL","Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device",[13],"Device: Omnipod 5 or Medtronic 780G",{"label":15,"type":10,"description":16,"interventionNames":17},"current HCL non-user: HCL x 12 months, then HCL x an additional 12 months","Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 months","Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months",[13,22],"Behavioral: HARPdoc Education",{"label":24,"type":25,"description":26,"interventionNames":27},"current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 months","ACTIVE_COMPARATOR","Usual Care and My HypoCOMPaSS education over 12 months for individuals currently not using a hybrid closed loop device, then hybrid closed loop device for 12 months",[13,28],"Behavioral: My HypoCOMPaSS Education",{"label":30,"type":25,"description":31,"interventionNames":32},"current HCL non-user: Usual Care and My HypoCOMPaSS x 24 months","Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device",[28],{"label":34,"type":10,"description":35,"interventionNames":36},"current HCL user: HCL x 24 months","Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device",[13],{"label":38,"type":10,"description":39,"interventionNames":40},"current HCL user: HCL x 12 months, then HCL x an additional 12 months","Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months",[13],{"label":42,"type":10,"description":43,"interventionNames":44},"current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 months","Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months",[13,22],{"label":46,"type":25,"description":47,"interventionNames":48},"current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 months","Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device for 12 months",[13,28],{"label":50,"type":25,"description":51,"interventionNames":52},"current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 months","Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device plus My HypoCOMPaSS eduction + HARPdoc education for 12 months",[13,28,22],{"label":54,"type":10,"description":55,"interventionNames":56},"current HCL user: HCL + My HypoCOMPaSS x 24 months","Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device",[13,28],[58,64,69],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DEVICE","Omnipod 5 or Medtronic 780G","Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.",[19,15,9,24,50,54,46,42,38,34],null,{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":63},"BEHAVIORAL","My HypoCOMPaSS Education","My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups. Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.",[24,30,50,54,46],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":63},"HARPdoc Education","The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.",[19,50,42],[74,78,82],{"name":75,"affiliation":76,"role":77},"Vernon M Chinchilli, PhD","Penn State College of Medicine","PRINCIPAL_INVESTIGATOR",{"name":79,"affiliation":80,"role":81},"Elizabeth R Seaquist, MD","University of Minnesota","STUDY_CHAIR",{"name":83,"affiliation":84,"role":81},"Simon Heller, MD","University of Sheffield",[86,92],{"name":87,"role":88,"phone":89,"phoneExt":90,"email":91},"Abid Kazi, PhD","CONTACT","717-531-0003","320036","akazi@pennstatehealth.psu.edu",{"name":93,"role":88,"phone":89,"phoneExt":94,"email":95},"Venus Grella, MPH","343413","vgrella@pennstatehealth.psu.edu",[97,117,136,152,167,184,206,224],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"University of California, San Diego","RECRUITING","La Jolla","California","92037","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-117.2742,32.84727,{"lat":109,"lon":108},[112,116],{"name":113,"role":88,"phone":114,"phoneExt":63,"email":115},"Jeremy H Pettus, MD","858-246-2160","jpettus@ucsd.edu",{"name":113,"role":77,"phone":63,"phoneExt":63,"email":63},{"facility":118,"status":99,"city":119,"state":120,"zip":121,"country":103,"countryCode":104,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"AdventHealth","Orlando","Florida","32804",{"type":106,"coordinates":123},[124,125],-81.37924,28.53834,{"lat":125,"lon":124},[128,132,134],{"name":129,"role":88,"phone":130,"phoneExt":63,"email":131},"Brooke Hartwell","407-303-2519","brooke.hartwell@adventhealth.com",{"name":133,"role":77,"phone":63,"phoneExt":63,"email":63},"Richard E Pratley, MD",{"name":135,"role":77,"phone":63,"phoneExt":63,"email":63},"Anna Casu, MD",{"facility":137,"status":99,"city":138,"state":139,"zip":140,"country":103,"countryCode":104,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"University of Kentucky","Lexington","Kentucky","40508",{"type":106,"coordinates":142},[143,144],-84.47772,37.98869,{"lat":144,"lon":143},[147,151],{"name":148,"role":88,"phone":149,"phoneExt":63,"email":150},"Simon Fisher, MD, PhD","859-562-0473","simon.fisher@uky.edu",{"name":148,"role":77,"phone":63,"phoneExt":63,"email":63},{"facility":80,"status":99,"city":153,"state":154,"zip":155,"country":103,"countryCode":104,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Minneapolis","Minnesota","55455",{"type":106,"coordinates":157},[158,159],-93.26384,44.97997,{"lat":159,"lon":158},[162,166],{"name":163,"role":88,"phone":164,"phoneExt":63,"email":165},"Sarah Zaun","612-301-7040","studydiabetes@umn.edu",{"name":79,"role":77,"phone":63,"phoneExt":63,"email":63},{"facility":168,"status":99,"city":169,"state":170,"zip":171,"country":103,"countryCode":104,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":106,"coordinates":173},[174,175],-75.16362,39.95238,{"lat":175,"lon":174},[178,182],{"name":179,"role":88,"phone":180,"phoneExt":63,"email":181},"Cornelia (Ginger) Dalton-Bakes","215-746-2085","corneliv@pennmedicine.upenn.edu",{"name":183,"role":77,"phone":63,"phoneExt":63,"email":63},"Michael R Rickels, MD, MS",{"facility":185,"status":99,"city":186,"state":187,"zip":188,"country":189,"countryCode":190,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"University of Melbourne","Fitzroy","Victoria","3065","Australia","AU",{"type":106,"coordinates":192},[193,194],144.97833,-37.79839,{"lat":194,"lon":193},[197,201,204],{"name":198,"role":88,"phone":199,"phoneExt":63,"email":200},"Katrin Brown","61 3 9231 2574","katie.brown@unimelb.edu.au",{"name":202,"role":88,"phone":199,"phoneExt":63,"email":203},"Catriona Sims","catriona.sims@unimelb.edu.au",{"name":205,"role":77,"phone":63,"phoneExt":63,"email":63},"David O'Neal, MD",{"facility":207,"status":99,"city":208,"state":63,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"University of Leicester","Leicester","LE5 4PW","United Kingdom","UK",{"type":106,"coordinates":213},[214,215],-1.13169,52.6386,{"lat":215,"lon":214},[218,222],{"name":219,"role":88,"phone":220,"phoneExt":63,"email":221},"Andrew Kingsnorth","44 116-258-4874","a.kingsnorth@leicester.ac.uk",{"name":223,"role":77,"phone":63,"phoneExt":63,"email":63},"Pratik Choudhary, MBBS",{"facility":84,"status":99,"city":225,"state":63,"zip":226,"country":210,"countryCode":211,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Sheffield","S10 2RX",{"type":106,"coordinates":228},[229,230],-1.4659,53.38297,{"lat":230,"lon":229},[233,236],{"name":83,"role":88,"phone":234,"phoneExt":63,"email":235},"44 114-215-9009","s.heller@sheffield.ac.uk",{"name":83,"role":77,"phone":63,"phoneExt":63,"email":63},{"type":77,"investigatorFullName":238,"investigatorTitle":239,"investigatorAffiliation":240,"oldNameTitle":63,"oldOrganization":63},"Vernon Michael Chinchilli","Distinguished Professor","Penn State Health Milton S Hershey Medical Center",[242,245,246,247,248,249,250,251,252,254],{"name":243,"class":244},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":80,"class":6},{"name":137,"class":6},{"name":168,"class":6},{"name":118,"class":6},{"name":207,"class":6},{"name":84,"class":6},{"name":185,"class":6},{"name":253,"class":6},"Jaeb Center for Health Research",{"name":98,"class":6},"100541080","closed-loop-and-education-for-hypoglycemia-awareness-restoration-100541080",false,"NCT06325202","Closed Loop and Education for Hypoglycemia Awareness Restoration","Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)","CLEAR","Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes\n* Gold Score or Clarke Score ≥ 4 (highly associated with IAH)\n* Random non-fasting C-peptide \\\u003C 200 pmol\u002FL\n* Diabetes duration ≥ 10 years\n* HbA1c \\\u003C 10.5%\n* Total Daily Insulin Dose of \\\u003C 1 unit\u002Fkg\n* Ability to read and speak English (because validated non-English versions of the cognitive tests and the educational interventions are not available)\n\nExclusion Criteria:\n\n* Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)\n* Active alcohol or drug abuse (as defined by DSM criteria of either 1) recurrent use of alcohol\u002Fdrugs resulting in a failure to fulfill major role obligations at work, school, or home, 2) recurrent alcohol\u002Fdrug use in situations in which it is physically hazardous, or 3) recurrent alcohol or drug-related legal problems)\n* Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, inadequate social support)\n* Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for \\>12 months and on a stable regimen of anti-convulsant therapy\n* Skin conditions that would preclude the use of a CGM\n* Super-physiologic exposure to steroids within one month of enrollment\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2\n* History of bariatric surgery that irreversibly alters gut innervation and structure\n* Hyper- or hypokalemia (serum potassium \\>5.5 or \\\u003C3.5 mmol\u002FL)\\*\n* Hemoglobin \\\u003C 10 g\u002FdL\\*\n* Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses\n* Pregnancy, plan for pregnancy, or breast feeding\n* Abnormal thyroid function tests of clinical significance, as determined by PI\\*\n* Liver transaminases \\> 3 times the upper limit of normal\\*\n* Hospitalization for mental illness in last year\n* History of adrenalectomy\n\n  * At discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant. The participant may be screened again.","ALL","18 Years","75 Years",{"count":267,"type":268},324,"ESTIMATED","INTERVENTIONAL",[271],"NA","The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.",[274],"Diabetes Mellitus, Type 1",[276,277,278],"impaired awareness of hypoglycemia","hybrid closed loop device","continuous glucose monitor","2026-02-27",{"date":281,"type":282},"2026-03-03","ACTUAL",{"date":284,"type":282},"2025-10-03",{"date":286,"type":268},"2029-07-31",{"name":5,"class":6},8]