[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642876":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":20,"responsibleParty":38,"collaborators":40,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":20},{"fullName":5,"class":6},"Ideal Medical Technologies","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FUSION closed loop glucose control system safety study","EXPERIMENTAL","All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours",[13],"Device: FUSION closed loop glucose control system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","FUSION closed loop glucose control system","The FUSION system will be used to control the subjects glucose to a range of 100-140 mg\u002FdL. Data will be collected for up to 24 hours, or upon early termination of the study session.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Leon M DeJournett, MD","STUDY_DIRECTOR",{"name":26,"affiliation":27,"role":28},"Francisco Pasquel, MD, MPH","Emory School of Medicine","PRINCIPAL_INVESTIGATOR",[30,34],{"name":23,"role":31,"phone":32,"phoneExt":20,"email":33},"CONTACT","1-828-337-9960","leondej@idealmedtech.com",{"name":35,"role":31,"phone":36,"phoneExt":20,"email":37},"Jeremy DeJournett, EE","1-828-545-9110","jeremy@idealmedtech.com",{"type":39,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[41,44],{"name":42,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":45,"class":46},"Emory University","OTHER","100642876","closed-loop-glucose-control-in-a-simulated-icu-setting-100642876",false,"NCT07646067","Closed Loop Glucose Control in a Simulated ICU Setting","Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes","Inclusion Criteria:\n\n* Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:\n\n  1. Are 18-70 years of age, inclusive.\n  2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.\n  3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 3 months.\n  4. Use insulin injections at home for glucose control.\n  5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.\n  6. Have a hemoglobin in the range for sex:\n\n     1. Females: 7-15.5 grams\u002FdL.\n     2. Males: 7-17.5 grams\u002Fdl.\n  7. Have adequate venous access sites in upper extremities.\n  8. Body weight between 40 - 150 kg.\n\nExclusion Criteria:\n\n1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.\n2. Have a known hypersensitivity to any of the components of study treatment.\n3. Have skin disease\u002Finjury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.\n4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.\n5. Have a medical condition that in the opinion of the investigator could affect study participation and\u002For personal well-being.\n6. Have a clinically significant history or presence of any of the following conditions:\n\n   1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.\n   2. Has an estimated GFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 or End Stage Kidney Disease on renal replacement therapy.\n   3. Have congestive heart failure greater than class 1 on the NYHA classification system.\n   4. Have a history of seizures.\n   5. Have a history of cerebrovascular accident.\n   6. Have a history of ischemic heart disease.\n7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:\n\n   1. Pregnant.\n   2. Refuse to agree to a pregnancy test at the time of enrollment.\n   3. Have a positive urine pregnancy test at the time of enrollment.\n8. Have a positive Influenza or COVID test within 14 days of visit 3.\n9. Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.\n10. Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3.\n11. Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.","ALL","18 Years","70 Years",{"count":58,"type":59},6,"ESTIMATED","INTERVENTIONAL",[62],"NA","This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.\n\nThe persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg\u002FdL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.",[65,66,67],"Type 1 Diabetes","Type 2 Diabetes","Stress Induced Hyperglycemia",[69,70,71,72,67,65,66,73,74,75,76,77,78],"Artificial Pancreas","Intensive Care Unit","ICU","Closed Loop Glucose Control","Inpatient","Hospital","Hypoglycemia","Hyperglycemia","Glucose Variability","Fully Autonomous","NOT_YET_RECRUITING","2026-06-09",{"date":82,"type":83},"2026-06-12","ACTUAL",{"date":85,"type":59},"2026-07",{"date":87,"type":59},"2027-12",{"name":5,"class":6}]