[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594610":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":72,"collaborators":41,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":41,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":99,"whyStopped":41,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",[8,14,19,23,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Start high-GI","ACTIVE_COMPARATOR","T=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for high GI meal, meal starts T=30: meal ends",[13],"Other: High glyceamic index meal",{"label":15,"type":16,"description":17,"interventionNames":18},"Pre high-GI","EXPERIMENTAL","T=0: meal bolus for high GI meal T=15: meal starts T=30: meal ends",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Post high-GI","T=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for high GI meal",[13],{"label":24,"type":16,"description":25,"interventionNames":26},"Pre low-GI","T=0: meal bolus for low GI meal T=15: meal starts T=30: meal ends",[27],"Other: Low glyceamic index meal",{"label":29,"type":16,"description":30,"interventionNames":31},"Start low-GI","T=0: having already rested for 30 min, the participant continues to rest T=15: meal bolus for low GI meal, meal starts T=30: meal ends",[27],{"label":33,"type":16,"description":34,"interventionNames":35},"Post low-GI","T=0: having already rested for 30 min, the participant continues to rest T=15: meal starts T=30: meal ends T=45: meal bolus for low GI meal",[27],[37,42],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"High glyceamic index meal","Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with high glycemic index.",[20,15,9],null,{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Low glyceamic index meal","Meal sizes are standardized regarding the amount of carbohydrate, always 50 g. The composition of these meals focuses on selecting carbohydrates with low glycemic index.",[33,24,29],[47],{"name":48,"affiliation":49,"role":50},"Kirsten Nørgaard, Professor","Steno Diabetes Center Copenhagen Clinical Translational Research, Diabetes Technology","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":41,"email":56},"Karen Rytter, RN, PhD","CONTACT","+45 39680800","karen.rytter@regionh.dk",{"name":58,"role":54,"phone":55,"phoneExt":41,"email":59},"Ajenthen Ranjan, MD, PhD","ajenthen.ranjan@regionh.dk",[61],{"facility":49,"status":41,"city":62,"state":41,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":41},"Herlev","DK-2730","Denmark","DK",{"type":67,"coordinates":68},"Point",[69,70],12.43998,55.72366,{"lat":70,"lon":69},{"type":50,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Kirsten Nørgaard","MD, DMSc","100594610","the-steno-opti-bolus-timing-studies-100594610",false,"NCT07021690","The Steno Opti-Bolus-Timing Studies","Timing Insulin for Meals Using AID Systems","OBT Studies","Inclusion criteria:\n\nType 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR \\> 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol\u002FL\n\nExclusion criteria:\n\nUse of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.\n\nCurrent participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results","ALL","18 Years","70 Years",{"count":87,"type":88},40,"ESTIMATED","INTERVENTIONAL",[91],"NA","The project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates.\n\nWe hypothesise that a bolus given 15 minutes before the meal will result in the best blood glucose levels after the meal, regardless of the type of carbohydrates.\n\nParticipants will attend 6 experimental days over a maximum of 3 months, where they will be served either breakfast or lunch at the research site, depending on sub-study (breakfast or Lunch sub-study). Three different bolus timings will be tested, with either rapidly absorbed carbohydrates or slowly absorbed carbohydrates, in a randomized order for each participant. Participants will take insulin for the meal using the bolus calculator in the pump, either 15 minutes before, at the start of the meal, or 30 minutes after the meal. The development in sensor glucose will then be monitored for up to 4 hours after the meal.",[94],"Type 1 Diabetes (T1D)",[96,97,98],"AID system","bolus timing","Glycemic index","NOT_YET_RECRUITING","2025-06-13",{"date":102,"type":103},"2025-06-15","ACTUAL",{"date":105,"type":88},"2025-06-30",{"date":107,"type":88},"2027-06",{"name":5,"class":6},1]