[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FIDAM RDC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100655718","changes-in-person-reported-outcomes-and-behavior-using-the-accu-chek-smartguide-cgm-and-predict-app-100655718",false,"NCT07814508","Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App","Changes in Person-reported Outcomes and Behavior Due to a Predictive Algorithm: A Pre-post Trial With the Accu-Chek SmartGuide CGM and the Predict App Solution","Inclusion Criteria:\n\n* Type 1 diabetes or Type 2 diabetes with intensified insulin therapy (defined as basal-bolus therapy with self-adjustment of bolus doses)\n* CGM use during the past 3 months (without predictive features)\n* Age ≥ 18 years\n* HbA1c \\\u003C 10%\n* Informed consent\n\nExclusion Criteria:\n\n* Use of the SmartGuide CGM solution\n* AID use\n* Current treatment with psychiatric medications\n* Diabetes duration \\\u003C 3 months\n* Current or planned pregnancy\n* Peripheral neuropathy that will impact sleep quality according to the judgement of the participant\n* Severe complications (e.g. kidney disease, cancer)","ALL","18 Years",{"count":19,"type":20},89,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes.\n\nThe main questions this study aims to answer are:\n\n* Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia?\n* Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment?\n* Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information?\n\nParticipants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Diabetes (DM)","Diabetes Mellitus","Diabetes Mellitus Type 2","Diabetes Mellitus Type 1","Diabetes Mellitus ( Type 1 and Type 2)","Fear of Hypoglycemia","Sleep Quality","Diabetes Distress","Ecological Momentary Assessment","Glycemic Responses","Glycemic Variability","Glucose Control","Continuous Glucose Monitoring System","Prediction",[41,42,27,31,43],"Accu-Chek SmartGuide CGM","Predict App solution","Continuous glucose monitoring system","RECRUITING","2026-09-05",{"date":47,"type":48},"2026-09-11","ACTUAL",{"date":50,"type":48},"2026-02-01",{"date":52,"type":20},"2026-10-31",{"name":54,"class":55},"FIDAM RDC","NETWORK",""]