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Clinical Trial Details

Trial ID: L3566
Source ID: NCT04949867
Associated Drug: Glucagon
Title: Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes
Acronym: DHCL2021
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Glucagon|DEVICE: Closed-loop System
Outcome Measures: Primary: Percentage of time with glucose values < 3.9 mmol/l as measured by the continuous glucose monitor, Percentage, 26 hours during closed-loop control | Secondary: Number of carbohydrate interventions to treat hypoglycemia, 26 hours during closed-loop control|Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by continuous glucose monitor and plasma glucose, Percentage, 26 hours during closed-loop control|Percentage of time with glucose values < 3.9 mmol/l as measured by plasma glucose, Percentage, 26 hours during closed-loop control|Percentage of time with glucose values in the range > 13.9 mmol/l measured by continuous glucose monitor and plasma glucose, Percentage, 26 hours during closed-loop control|Percentage of time with glucose values < 3.0 mmol/l as measured by continuous glucose monitor and plasma glucose, Percentage, 26 hours during closed-loop control|Mean blood glucose value measured by continuous glucose monitor and plasma glucose, mmol/L, 26 hours during closed-loop control|Number of hypoglycemic episodes < 3.9 mmol/l on continuous glucose monitor and plasma glucose, No., 26 hours during closed-loop control|Continuous glucose monitored glycemic variability measured as SD, mmol/L, 26 hours during closed-loop control|Continuous glucose monitored glycemic variability measured as CV, percentage, 26 hours during closed-loop control|Composite outcome: Percentage of participants achieving (1) time in range (3.9-10) > 70 %, (2) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (3) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by CGM and YSI, percentage, 26 hours during closed-loop control|Total insulin dose, units, 26 hours during closed-loop control|Total glucagon dose, mg, 26 hours during closed-loop control|Number of manual insulin boluses, No., 26 hours during closed-loop control|Number of adverse events - Nausea, No of event if visual analog scale (0-100) increase \>10 from baseline, 26 hours during closed-loop control|Number of adverse events - Headache, No of event if visual analog scale (0-100) increase \>10 from baseline, 26 hours during closed-loop control|Number of adverse events - Palpitation, No of event if visual analog scale (0-100) increase \>10 from baseline, 26 hours during closed-loop control|Number of vomits, No of event if visual analog scale (0-100) increase \>10 from baseline, 26 hours during closed-loop control|Difference between actual and participant-estimated carbohydrate content in meals, g per meal, 26 hours of closed-loop glucose control|Mean Borg scale, Scale of perceived exertion from 6 (no effort activity) to 20 (max effort activity), During 45 minutes exercise|Physical activity intensity measured by ActiGraph GT9X Link, Percentage of sedentary activity, 26 hours|Sleep efficiency measured by ActiGraph GT9X Link, The ratio of total sleep time to time in bed, 26 hours
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Technical University of Denmark|Herlev Hospital
Gender: ALL
Age: CHILD
Phases: PHASE4
Enrollment: 11
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-05-20
Completion Date: 2022-04-26
Results First Posted:
Last Update Posted: 2022-08-18
Locations: Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark|Herlev Hospital, Herlev, 2730, Denmark
URL: https://clinicaltrials.gov/show/NCT04949867