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Clinical Trial Details

Trial ID: L2539
Source ID: NCT04053712
Associated Drug: Glucagon
Title: Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes
Acronym: DHCL2019
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Hypoglycemia
Interventions: DRUG: Glucagon|DEVICE: Closed-loop system
Outcome Measures: Primary: Percentage of time with glucose values < 3.9 mmol/l as measured by glucose sensor, 33 hours|Number of carbohydrate interventions to treat hypoglycemia, Carbohydrate interventions are predefined and provided in case of hypoglycemia, 33 hours | Secondary: Percentage of time with glucose values < 3.9 mmol/l as measured by venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Percentage of participants achieving (A) time in range (3.9-10 mmol/l) > 70 %, (B) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (C) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by glucose sensor and venous plasma glucose, A composite outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Mean blood glucose value measured by glucose sensor and venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Percentage of time with glucose values in the range 3.9-8.0 mmol/l measured by glucose sensor and venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by glucose sensor and venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Percentage of time with glucose values in the range > 13.9 measured by glucose sensor and venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Percentage of time with glucose values < 3.0 mmol/l as measured by glucose sensor and venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Number of hypoglycemic episodes (<3.9 mmol/l and <3.0 mmol/l) overnight and during daytime, 33 hours|Nadir blood glucose value for each hypoglycemic episode as measured by glucose sensor and venous plasma glucose, 33 hours|Glucose sensor glycemic variability measured as SD and CV during overnight and during daytime, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Low Blood Glucose Index (LBGI) overnight and during daytime by glucose sensor and venous plasma glucose, Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Percentage of participants with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol), 33 hours|Percentage of patients with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ their standard therapy mean glucose value (calculated based on HbA1c measurement), 33 hours|Mean Absolute Relative Difference (MARD) between glucose sensor and venous plasma glucose, Participants have two glucose sensors during the study, 33 hours|Percentages of values between glucose sensor and venous plasma glucose in zone A, B, C, D and E in the Clarke Error Grid analysis., Participants have two glucose sensors during the study. One sensor closed to the infusion of glucagon., 33 hours|Mean blood pressure over the study period (mmHG), Blood pressure and pulse taken at predefined timepoints, 33 hours|Mean pulse rate over the study period (beats per min), Blood pressure and pulse taken at predefined timepoints, 33 hours|Mean nausea level measured with a visual analog scale (VAS range: 0-10), Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Total insulin dose per study day (UI), 33 hours|Total time of insulin suspension per study day (UI), 33 hours|Total glucagon dose per study day (microgram), the outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Mean plasma glucagon, the outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Mean plasma insulin aspart, the outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00., 33 hours|Difference in participant estimated grams of carbohydrate and actual carbohydrate in study meals, Meals presented at the study will be estimated for carbohydrate content by the participant on, 33 hours|Difference in participant estimated blood glucose level and plasma glucose level at predefined timepoints, Self-assessment of glucose levels (Clarke Error Grid), 33 hours|Total energy expenditure during the study visit (kcal/kg) measured by ActiGraph GT9X Link, Freedson and Sasaki MET prediction equations to determine energy expenditure in MET, 33 hours|Steps taken during the study visit measured by ActiGraph GT9X Link, 33 hours|Minutes per study day (min/d) spent in different levels of activity (sedentary, light, moderate, vigorous, or MVPA) measured by ActiGraph GT9X Link, 45 min|Minutes between lights off and the first sleep episode (Sleep latency) measured by ActiGraph GT9X Link, 14 hours|Total sleep time measured by ActiGraph GT9X Link, Minutes between sleep onset and wake time, 14 hours|The percentage of time asleep from lights off to lights on (sleep efficiency) measured by ActiGraph GT9X Link, 14 hours|Mean Borg scale level during exercise (RANGE:0-10), Assessed every 5-10 minutes during bicycling, 45 min
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Technical University of Denmark|University of Copenhagen|Danish Diabetes Academy
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2019-07-16
Completion Date: 2021-03-19
Results First Posted:
Last Update Posted: 2022-08-18
Locations: Steno Diabetes Center Copenhagen, Gentofte, Denmark
URL: https://clinicaltrials.gov/show/NCT04053712