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Clinical Trial Details

Trial ID: L4375
Source ID: NCT05660941
Associated Drug: Lispro
Title: Automated Fully Closed-Loop Insulin Delivery in Type 1 Diabetes With Ultra-Rapid Lispro (ACOLYTE Study)
Acronym: ACOLYTE
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Lispro|DRUG: Lispro
Outcome Measures: Primary: Time in range, The primary outcome is time spent in the target glucose range (3.9 to 10.0 mmol/l) based on sensor glucose levels, between the hours of 11:00 and 17:00 hours, during inpatient stay, 6 hours | Secondary: Area under curve, • Incremental area above the curve of sensor glucose level during the first 4 hours after the meal., 4 hours|Time below target, Time spent below target glucose (\<3.9mmol/l), 6 Hours|Time above target, Time spent abovetarget glucose (10.0mmol/l), 6 Hours|Mean glucose and glycaemic variability, Average, coefficient of variation and standard deviation glucose levels, 6 hours|Insulin dose, Total, basal and bolus insulin dose, 6 hours|Time above and below significant sensor glucose levels, The time with sensor glucose levels \< 3.5 mmol/l, 3.0 and \<2.8 mmol/l and the time with sensor glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l), 6 hours
Sponsor/Collaborators: Sponsor: Manchester University NHS Foundation Trust
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: 2023-07-21
Completion Date: 2024-05-01
Results First Posted:
Last Update Posted: 2023-10-31
Locations: Manchester University NHS Foundation Trust, Manchester, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05660941