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Clinical Trial Details

Trial ID: L3352
Source ID: NCT06046417
Associated Drug: Pramlintide
Title: A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
Acronym: FCL
Status: RECRUITING
Study Results: NO
Results:
Conditions: type1diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: Pramlintide|DRUG: Lyumjev|DEVICE: Automated Insulin Delivery (AID) system
Outcome Measures: Primary: Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)., 18 days | Secondary: Percentage of time of glucose levels spent between 3.9-7.8 mmol/L., 18 days|Percentage of time of glucose levels spent between 3.0-3.9 mmol/L., 18 days|Percentage of time of glucose levels spent between 10.0-13.9 mmol/L., 18 days|Mean glucose levels., 18 days|Standard deviation of glucose levels., 18 days|Coefficient of variance of glucose levels., 18 days|Total pramlintide delivery (overall, basal, and bolus)., 18 days|Total insulin delivery (overall, basal, and bolus)., 18 days|Mean score on the Type 1 Diabetes Distress Scale (T1DDS) excluding the physician subscale., A scale from 1-6 indicating overall diabetes distress. Higher scores indicate higher levels of diabetes distress. Any total subscale score of \>2.0 is considered clinically significant., 18 days|Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2)., A scale from 1-5 with higher scores indicating a greater fear of hypoglycemia., 18 days|Mean score on the INSPIRE questionnaire for adults (INSPIRE)., A scale from 1-5 with higher scores reflecting more favorable opinions about using Automated Insulin Delivery (AID)., 18 days|Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ)., A 1-5 scale with higher values reflecting a greater quantity and severity of diabetes bowel symptoms., 18 days|Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al., A 1-6 scale with higher values indicating more satisfaction with treatment., 18 days|Thematic interview analysis, Semi-structured interviews will be carried out after every intervention. We will analyze their qualitative content., 18 days | Other: Safety Endpoints, Number of adverse events, including gastrointestinal symptoms., 18 days
Sponsor/Collaborators: Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-30
Completion Date: 2025-06
Results First Posted:
Last Update Posted: 2024-04-18
Locations: Research Institute of the McGill University Health Center, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT06046417