[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614672":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":137,"collaborators":140,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":18,"enrollmentInfo":154,"targetDuration":18,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":164,"whyStopped":18,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated",[13],"Device: DailyDose",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Usual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","DailyDose","Our team has developed a smartphone-based application, DailyDose Decision Support Tool (DailyDose), that combines continuous glucose monitoring data and insulin data to provide decision support for people living with T1D taking MDI. DailyDose is an iPhone application that is designed to support this population by 1) allowing for bolus calculation based on inputs including carbohydrate intake, CGM value and trend, and exercise information, 2) providing recommendations for carbohydrate intake based on exercise type, intensity, and duration, and 3) providing weekly recommendations for adjustments in insulin doses at specific times of day, including basal insulin dose, carbohydrate ratios or fixed mealtime doses, and correction factors .",[9],[26],{"name":27,"affiliation":5,"role":28},"Leah Wilson, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","503-494-3273","wilsolea@ohsu.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Samrita Thapa","503-494-8421","thapasa@ohsu.edu",[39,60,69,88,106,123],{"facility":40,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of California, San Diego","La Jolla","California","92037","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.2742,32.84727,{"lat":50,"lon":49},[53,57],{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Jeremy Pettus, MD","858-246-2169","jpettus@health.ucsd.edu",{"name":58,"role":31,"phone":18,"phoneExt":18,"email":59},"Todd May","tmay@ucsd.edu",{"facility":61,"status":18,"city":62,"state":42,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":18},"University of Southern California","Los Angeles","90022",{"type":47,"coordinates":65},[66,67],-118.24368,34.05223,{"lat":67,"lon":66},{"facility":70,"status":18,"city":71,"state":72,"zip":73,"country":44,"countryCode":45,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Barbara Davis Center","Aurora","Colorado","80045",{"type":47,"coordinates":75},[76,77],-104.83192,39.72943,{"lat":77,"lon":76},[80,84],{"name":81,"role":31,"phone":82,"phoneExt":18,"email":83},"Halis Akturk, MD","303-724-0467","halis.akturk@cuanschutz.edu",{"name":85,"role":31,"phone":86,"phoneExt":18,"email":87},"Emma Mason","303-724-5895","emma.mason@cuanschutz.edu",{"facility":89,"status":18,"city":90,"state":91,"zip":92,"country":44,"countryCode":45,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Joslin Diabetes Center, Harvard School of Medicine","Boston","Massachusetts","02215",{"type":47,"coordinates":94},[95,96],-71.05977,42.35843,{"lat":96,"lon":95},[99,103],{"name":100,"role":31,"phone":101,"phoneExt":18,"email":102},"Joslin Toschi, MD","617-309-2440","Elena.Toschi@joslin.harvard.edu",{"name":104,"role":31,"phone":18,"phoneExt":18,"email":105},"Christine Slyne","Christine.slyne@joslin.harvard.edu",{"facility":107,"status":18,"city":108,"state":108,"zip":109,"country":44,"countryCode":45,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Mount Sinai School of Medicine","New York","10029",{"type":47,"coordinates":111},[112,113],-74.00597,40.71427,{"lat":113,"lon":112},[116,120],{"name":117,"role":31,"phone":118,"phoneExt":18,"email":119},"Carol Levy, MD","212-241-0068","carol.levy@mssm.edu",{"name":121,"role":31,"phone":18,"phoneExt":18,"email":122},"Shaziah Hassan","Shaziah.hassan@mssm.edu",{"facility":124,"status":18,"city":125,"state":126,"zip":127,"country":44,"countryCode":45,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Oregon Health & Science University , Portland","Portland","Oregon","97239",{"type":47,"coordinates":129},[130,131],-122.67621,45.52345,{"lat":131,"lon":130},[134,135],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":136,"role":28,"phone":18,"phoneExt":18,"email":18},"Peter Jacobs, PhD",{"type":28,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Leah Wilson","Associate Professor",[141],{"name":142,"class":143},"Leona M. & Harry B. Helmsley Charitable Trust","UNKNOWN","100614672","app-based-certified-diabetes-education-therapy-ab-cde-100614672",false,"NCT07282639","App-Based Certified Diabetes Education Therapy (AB-CDE)","Development and Evaluation of App-Based Certified Diabetes Education (AB-CDE) Therapy for People Living With T1D Using MDI","AB-CDE","Inclusion Criteria:\n\n1. Diagnosis of type 1 diabetes mellitus for at least 1 year.\n2. Age 18 years and older.\n3. Able to read, write and understand spoken English\n4. HbA1c or GMI 7.5- 11.5% at screening. GMI (%) = 3.31 + 0.02392 × \\[mean glucose in mg\u002FdL\\] based on prior 30 days of CGM data with at least 70% time CGM active\\[6\\]\n5. Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit.\n6. Willing to use the approved study insulin and devices while on study - Humalog and Basaglar Tempo pens, Dexcom G6 CGM, study iPhone, Apple watch\n7. Willingness and ability to independently follow all study procedures, including attending all clinic and DSMES and behavioral health visits.\n8. Total daily insulin requirements of less than 200 units\n\nExclusion Criteria:\n\n1. Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill \u002F patch \u002F vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence.\n2. History of stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty.\n3. Renal insufficiency (GFR \\\u003C 60 ml\u002Fmin, using either MDRD\\*\\* or CKD-EPI# equation as reported by the laboratory).\n4. Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.\n5. History of severe hypoglycemia during the 3 months prior to screening or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.\n6. History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.\n7. History of psychiatric admission during the 6 months prior to screening.\n8. Adrenal insufficiency.\n9. Any active infection.\n10. Known or suspected abuse of alcohol, narcotics, or illicit drugs.\n11. Uncontrolled seizure disorder.\n12. Active foot ulceration.\n13. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.\n14. Major surgical operation within 30 days prior to screening.\n15. Use of an investigational drug within 30 days prior to screening.\n16. Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).\n17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.\n18. Allergy to Humalog or Basaglar insulin.\n19. Current chronic administration of oral or parenteral corticosteroids.\n20. Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the 5 years prior to screening (except basal and squamous cell skin cancer).\n21. Initiation or titration of any medication used to lower glucose other than insulin in the 6 weeks prior to screening (e.g. metformin or semaglutide). Participants will not be excluded if they are non-insulin glucose lowering medication at a stable dose with no plans for discontinuation or dose modification during the course of the study). A positive response to any of the questions from the Physical Activity Readiness Questionnaire (see Appendix A) with one exception: participant will not be excluded if taking a single blood pressure medication and blood pressure is controlled on the medication (blood pressure is less than 140\u002F90 mmHg).\n22. Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.\n23. Gastroparesis.\n24. On a very low carbohydrate diet (less than 50g per day)\n25. Taking part in another diabetes or obesity-related treatment study.\n26. Any clinically significant disease or disorder which, in the opinion of the Investigator, may jeopardize the participant's safety or compliance with the protocol.","ALL","18 Years",{"count":155,"type":156},99,"ESTIMATED","INTERVENTIONAL",[159],"NA","The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for insulin dosing and carbohydrate intake during exercise or low blood sugar events. We want to find out if DailyDose can help lower blood sugar levels as measured by the hemoglobin A1c (HbA1c) test.",[162],"Type 1 Diabetes (T1D)",[150,22],"NOT_YET_RECRUITING","2025-12-23",{"date":167,"type":168},"2025-12-26","ACTUAL",{"date":170,"type":156},"2026-01-15",{"date":172,"type":156},"2027-12-15",{"name":5,"class":6},6]