[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641160":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":49,"collaborators":51,"id":58,"slug":20,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"ClinSurge Research","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sensor Characterization and Automated Glycaemic Control","EXPERIMENTAL","Sensor characterization, Part \"A\": Participants will undergo a 1.5-day in-patient stay using the DPP System. The pump and the CGM functions of the DPP System are controlled by separate smartphone applications. Blood glucose will be monitored with a Yellow Springs Instruments (YSI) glucose analyzer and a separate commercial CGM (Dexcom G7 CGM System). Participants will also undergo euglycemic glucose clamp testing to assess sensor response to basal and bolus insulin delivery. Automated glycaemic control, \"Part B\": Participants will undergo a 2.5-day in-patient stay using the DPP System and an automated glycaemic control (AGC) algorithm. During this period, they will consume standardized meals and engage in standardized exercise to evaluate glucose control.",[13],"Device: DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)","Participants will use the DPP System, an integrated insulin pump and continuous glucose monitoring-based device, during inpatient study visits. The system will be evaluated under multiple study conditions, including sensor characterization procedures and automated glycaemic control during standardized meals and exercise.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Karri Venn, BSc","CONTACT","647 274 4133","karri.venn@clinsurge.ca",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Eden Stein, B.Sc, M.Sc, MBA","416 688 0813","eden.stein@clinsurge.ca",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Toronto","Ontario","M4G 3E8","Canada",{"type":39,"coordinates":40},"Point",[41,42],-79.39864,43.70643,{"lat":42,"lon":41},[45,46],{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":47,"role":48,"phone":20,"phoneExt":20,"email":20},"Ronnie Aronson, M.D.","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52,55],{"name":53,"class":54},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"name":56,"class":57},"PharmaSens AG, Biel\u002FBienne Switzerland","UNKNOWN","100641160",false,"NCT07655076","Simultaneous Measurement and Responsive Treatment - Part 2","SMART02","Inclusion Criteria Part A:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Total daily insulin dose (TDD) between 30 and 100 IU.\n\nInclusion Criteria Part B:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Totally daily insulin dose (TDD) between 30 and 100 IU.\n\nExclusion Criteria (A and B):\n\n* Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Failure to comply with the study protocol or with the team's recommendations.\n* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).\n* Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study. Pregnancy will be verified by urine dipstick testing at the time of admission visit.\n* Severe hypoglycemic episode within one month of admission.\n* Severe diabetic ketoacidosis episode within one month of admission.\n* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.\n* Recent (\\\u003C6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.\n* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Current or ≤ one month use of supraphysiological doses of systemic glucocorticoids\n* Pronounced lipohypertrophy in the abdominal subcutaneous adipose tissue, which may impair sensor function or insulin infusion.\n* Insufficient abdominal surface area to support the wearing of three DPP systems in Part A.","ALL","18 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"EARLY_PHASE1","This research study is testing an investigational dual-port insulin patch pump that integrates a continuous glucose monitor (CGM) in adults with type 1 diabetes. The goal of the study is to better understand how insulin delivery near a CGM sensor affects glucose readings and to collect data to support development of a combined insulin pump and CGM system.\n\nPeople with type 1 diabetes require lifelong insulin therapy. Many use insulin pumps and CGMs, but these systems usually involve wearing multiple devices at different body sites. Managing several devices can increase treatment burden and may contribute to skin irritation, device failures, and challenges with glucose control.\n\nThis study is conducted in two in-patient parts. In Part A, participants will wear three investigational devices at the same time while glucose levels are closely monitored using laboratory blood tests and a commercial CGM. This part of the study is designed to measure how basal and bolus insulin delivery near the CGM sensor affects sensor accuracy and how quickly the sensor signal recovers after insulin delivery.\n\nIn Part B, participants will wear one investigational device while trained study staff use CGM information from the integrated sensor to guide insulin delivery recommendations generated by an automated glucose control algorithm. Insulin delivery decisions will be closely supervised, and glucose levels will be frequently monitored.\n\nParticipants will stay at the clinical research center for short, controlled study visits. Safety will be monitored throughout the study, with predefined procedures for treating low or high blood sugar. The information collected will be used to support further development of an integrated insulin pump and CGM system for people with type 1 diabetes.",[74,75,76,77],"Type 1 Diabetes Mellitus","T1D","Type 1 Diabetes","T1DM",[74,79,80,81,82,83,76,84,85],"Hybrid closed-loop system","Closed-loop insulin delivery","Automated insulin delivery","Continuous Glucose Monitoring","Insulin Pump","Insulin Patch Pump","Dual-port Insulin Patch Pump","2026-06-19",{"date":88,"type":89},"2026-06-23","ACTUAL",{"date":91,"type":89},"2026-05-19",{"date":93,"type":68},"2026-12-01",{"name":5,"class":6},1]