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Clinical Trial Details

Trial ID: L2504
Source ID: NCT04243629
Associated Drug: Rapid-Acting Insulin
Title: Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Type 1 Diabetes|Postprandial Hyperglycemia
Interventions: DRUG: Rapid-Acting Insulin|DRUG: Placebo|DRUG: Pramlintide Acetate|DEVICE: Artificial Pancreas
Outcome Measures: Primary: Time in target range, Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L), 4 weeks | Secondary: Time between 3.9 - 7.8 mmol/L, Percentage of time each participant spent with glucose levels between 3.9 - 7.8 mmol/L, 4 weeks|Time below 3,9, 3.3, and 2.8 mmol/L, Percentage of time each participant spent with glucose levels below 3.9, 3.3, and 2.8 mmol/L, 4 weeks|Time above 7.8, 10.0, 13.9, 16.7 mmol/L, Percentage of time each participant spent with glucose levels above 7.8, 10.0, 13.9, and 16.7 mmol/L, 4 weeks|Mean glucose level, Each participant's mean glucose level, 4 weeks|Total insulin delivery, Each participant's total insulin delivery, 4 weeks|Standard deviation and coefficient of variance, Each participant's standard deviation and coefficient of variance of glucose levels as a measure of glucose variability, 4 weeks|Gastrointestinal symptoms, Number of each participant's gastrointestinal symptoms, 4 weeks|Number of hypoglycemia events, Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L with the end of the event being 15 minutes \> 3.9 mmol/L., 4 weeks
Sponsor/Collaborators: Sponsor: McGill University | Collaborators: Canadian Institutes of Health Research (CIHR)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-12
Completion Date: 2024-04
Results First Posted:
Last Update Posted: 2023-03-15
Locations: McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT04243629