[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641892":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":35,"locations":40,"responsibleParty":82,"collaborators":35,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":35,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":35,"enrollmentInfo":93,"targetDuration":35,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":110,"whyStopped":35,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AID-arm","EXPERIMENTAL","In the AID-arm, participants will be equipped with a Freestyle libre-3 CGM to collect the glucose data and communicated with the mylife YpsoPump for insulin application. As part of the AID system, the participants will also be equipped with the CE-marked mylife Ypsopump to administer the needed insulin dose during the day. The insulin used for the pump for the glycaemic control of the participants will be insulin aspart.(6) The Freestyle libre-3 CGM and the YpsoPump will be coupled together in an AID system via the the mylife CamAPS HX app on a smartphone.",[13],"Device: automated insulin delivery system",{"label":15,"type":16,"description":17,"interventionNames":18},"Control-Arm","PLACEBO_COMPARATOR","In the control-arm, glucose levels are assessed with POC glucose testing at 03:00 h, pre-prandial at breakfast, lunch, and dinner, and before bedtime (22:00 h) or for subjects not eating at 03:00 h., 08:00 h., 12:00 h., 17:00 h., and 22:00 h as per standard of care. A blinded CGM is mounted for outcome analysis.\n\nAt admission, non-insulin antidiabetic medications will be paused, and the control-arm participants will be treated by usual-of-care with a pen based a basal-bolus regimen\n\nParticipants at Graz University Hospital are ordered the same basal-bolus insulin regimen as in the usual-of-care arm at Steno Diabetes center Copenhagen, however, insulin is not manually titrated, but titration is based daily on the GlucoTab system, a clinical decision support validated for the inpatient setting in titrating insulin for patients with type 2 diabetes as this is the usual of care at Graz University hospital.",[19,20],"Procedure: GlucoTab","Procedure: Control-arm",[22,30,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","automated insulin delivery system","To date, no randomized controlled trials have evaluated inpatient use - including bolus insulin - in patients with infectious disease.",[9],[28,29],"AID","cloosed-loop system",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","GlucoTab","Participants at Graz University Hospital are basal-bolus insulin regimen , however, insulin is not manually titrated, but titration is based daily on the GlucoTab system, a clinical decision support validated for the inpatient setting in titrating insulin for patients with type 2 diabetes as this is the usual of care at MUG. The GlucoTab-arm will be titrated initially by the principal Investigator or sub principal investigator and afterwards by the general ward nurses of MUG.",[15],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Control-arm","In the control-arm, glucose levels are assessed with POC glucose testing at 03:00 h, pre-prandial at breakfast, lunch, and dinner, and before bedtime (22:00 h) or for participants not eating at 03:00 h, 08:00 h, 12:00 h, 17:00 h, and 22:00 h. Those collected glucose levels will be automatically transferred to the EHR. If POC glucose testing is not prescribed or performed five times daily as standard of care, the research staff may encourage usual ward nurses to do so. The investigat will also mount a FreeStyle Libre-3 CGM on each participant like descripted in the section above to be able to have a better comparison of the glucose levels throughout the day in both arms. This glucose data will be blinded and as such only be available for the diabetes research team in the end of the trial and not for the general wards.\n\nAt admission, non-insulin antidiabetic medications will be paused, and the control-arm participants will be treated by usual-of-care with a pen based a basal-bolus regimen",[15],[41,66],{"facility":42,"status":35,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University Hospital of Graz","Graz","Styria","8036","Austria","AT",{"type":49,"coordinates":50},"Point",[51,52],15.44197,47.06733,{"lat":52,"lon":51},[55,60,64],{"name":56,"role":57,"phone":58,"phoneExt":35,"email":59},"Julia Mader, Prof. PD Dr.","CONTACT","+43 318 385 80254","julia.mader@medunigraz.at",{"name":61,"role":57,"phone":62,"phoneExt":35,"email":63},"Paul Klopf","+4331638526176","paul.klopf@stud.medunigraz.at",{"name":56,"role":65,"phone":35,"phoneExt":35,"email":35},"PRINCIPAL_INVESTIGATOR",{"facility":5,"status":35,"city":67,"state":35,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Copenhagen","2730","Denmark","DK",{"type":49,"coordinates":72},[73,74],12.56553,55.67594,{"lat":74,"lon":73},[77,81],{"name":78,"role":57,"phone":79,"phoneExt":35,"email":80},"Mikkel Thor Olsen, MD, PhD","+45 31 49 72 95","mikkel.thor.olsen@regionh.dk",{"name":78,"role":65,"phone":35,"phoneExt":35,"email":35},{"type":83,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100641892","automated-insulin-delivery-versus-daily-injections-for-hospital-diabetes-care-100641892",false,"NCT07645079","Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care","Inpatient Diabetes Management With Automated Insulin Delivery Systems Compared to Multiple Daily Injections With a Basal-bolus Regimen - a Randomized Controlled Trial","Inclusion Criteria:\n\n* A documented history of Type 2 diabetes mellitus (T2DM) which requires subcutaneous insulin therapy\n* acute infectious disease of any kind\n* age ≥ 18 years old\n* willingness and ability to comply with theclinical investigation plan\n* ability to communicate with the trial personal\n* an expected length of hospital stay for at least 2 days after enrolment\n\nExclusion Criteria:\n\n* Patients already using AID for their glycemic management\n* Patients in use of an insulin pump\n* Skin pathologies that hinder application of a FreeStyle Libre-3 CGM and mylife YpsoPump\n* Participation in another trial, which could influence the outcome of the trial\n* Any mental condition rendering the patient incapable of giving informed consent\n* Known or suspected allergy to adhesive material\u002Ftape of the Libre-3-sensor and\u002For YpsoPump\n* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient\n* Diagnoses\u002Ftreatments\u002Fclinical parameters prohibiting use of Insulin\u002FAID such as\n\n  * Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2 OR\n  * Treated with hydroxyurea\u002Fhydroxycarbamide OR\n  * Nutritional therapy (continuous enteral or parenteral feeding) OR\n  * Clinically relevant pancreatic disease OR\n  * Aystemic glucocorticoid treatment with prednisone equivalent dose \\>5 mg\u002Fday OR\n  * Expected to require admission to the intensive-care unit OR \\> Patients in dialysis","ALL","18 Years",{"count":94,"type":95},92,"ESTIMATED","INTERVENTIONAL",[98],"NA","Aim\n\nThe investigators aim to investigate if automated insulin delivery systems (AID) improve in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard-of-care with a pen-basal-bolus insulin regimen manually titrated by general staff at Herlev-Gentofte Hospital and a clinical decision support system (GlucoTab) titrating the basal-bolus regimen automatically daily at Graz University Hospital.\n\nPopulation\n\nHospitalized patients with type 2 diabetes in non-intensive care units (non-ICU) at medical wards at Copenhagen University Hospitals of Herley-Gentofte (affiliated with Steno Diabetes Center Copenhagen) and Medical University Hospital of Graz (N = 92).\n\nDesign\n\nThis is an investigator-initiated, two-armed, two-site, prospective, randomized, open-label, blinded endpoint (PROBE) trial.\n\nObjectives\n\nThe objective is to determine the glycemic and clinical effects of inpatient AID systems in non-ICU patients with type 2 diabetes. Participants will be randomized in a usual-of-care and an AID arm. Diabetes management will be performed by usual care in the control arm based on a basal-bolus insulin regimen and point-of-care (POC) glucose testing. A continuous glucose monitoring (CGM) system (Abbott FreeStyle Libre 3) will be used in all groups for outcome analysis and comparison between the groups. The CGM will be blinded for the control arm, to not interfere with the usual of care because of the higher amount of glucose data. The AID-arm will be managed by an AID system with real-time CGM data transmitted to nursing stations.\n\nOutcomes\n\nPrimary outcome: The primary outcome is the difference in CGM-recorded time in range (TIR) (70-180 mg\u002Fdl (3.9-10.0 mmol\u002Fl)) between the POC- and the CGM-arm according to the 2023 in-hospital CGM consensus during the entire hospital stay.\n\nSecondary outcomes: Outcomes are reported according to the 2023 in-hospital CGM consensus and specified in the protocol during the entire hospital stay, including three levels of time above range (TAR) 180-250mg\u002Fdl (10.0-13.9 mmol\u002Fl), \\>250mg\u002Fdl (\\>13.9 mmol\u002Fl), and \\>180mg\u002Fdl (\\>10.0 mmol\u002Fl); three levels of time below range (TBR) 54-70mg\u002Fdl (3.0-3.9 mmol\u002Fl), \\\u003C54mg\u002Fdl (\\\u003C3.0 mmol\u002Fl), and \\\u003C70mg\u002Fdl (\\\u003C3.9 mmol\u002Fl); events of hypoglycemia in three levels, 54-68mg\u002Fdl (3.0-3.8 mmol\u002Fl), \\\u003C54mg\u002Fdl (\\\u003C 3.0 mmol\u002Fl), and \\\u003C70mg\u002Fdl (\\\u003C3.9 mmol\u002Fl), where the glucose values between the two hypoglycemic events must all be \\>70mg\u002Fdl (\\>3.9 mmol\u002Fl) for at least 15 consecutive minutes(1), including prolonged hypoglycemic events (\\> 120 minutes), recurrent hypoglycemic events (events preceded by another hypoglycemic event), and recurrent hypoglycemic days (percentage of days with at least one hypoglycemic event on separate days that is preceded by another in-hospital day with hypoglycemia(1)); mean glucose level; standard deviation (SD) of the CGM glucose distribution; coefficient of variation (CV); and insulin doses during hospitalization.\n\nClinical outcomes: The investigator assess the length of hospital stay as calculated from time of admission until discharge; in-hospital mortality; admissions to intensive care unit; any in-hospital-related complications occurring at least one day after randomization and until discharge, as documented and defined by the treating physician in the electronic health record (e.g., acute kidney injurie, sepsis, etc.)\n\nMethod\n\nFor the usual-of-care-arm, glucose assessment is done by standard POC glucose testing and insulin is manually titrated by general staff at Herlev-Gentofte Hospital and the glucose assessment is done by standard POC glucose testing and insulin is manually titrated by the GlucoTab system titrating the basal-bolus regimen automatically daily at Graz University Hospital. For the AID-arm, CGM data informs in real time the mylife Ypsopump for automated insulin delivery.\n\nDevice\n\nThe investigational device is the AID system, containing of the mylife YpsoPump and the FreeStyle Libre 3 sensor.",[101,102,103],"Diabetes Mellitus Type 2","Infection","CGM",[105,28,103,106,107,108,109,32],"automated insulin delivery systems","continouse glucose monitoring","infectiouse disease","type 2 diabetes mellitus","diabetes mellitus type 2","NOT_YET_RECRUITING","2026-06-08",{"date":113,"type":114},"2026-06-12","ACTUAL",{"date":116,"type":95},"2026-07-01",{"date":118,"type":95},"2027-07-30",{"name":5,"class":6},2]