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Clinical Trial Details

Trial ID: L7037
Source ID: NCT06021145
Associated Drug: Empagliflozin
Title: Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo), Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on an automated insulin delivery system vs empagliflozin (2.5 mg) on an automated insulin delivery system. Percent measured as per continuous glucose monitor (CGM) data., 4 weeks | Secondary: Percentage of time spent in the glucose range between 3.9 and 7.8 mmol/L, Percent as per CGM data, 4 weeks|Percentage of time spent in the glucose range below 3.9 mmol/L and 3.0 mmol/L, Percent as per CGM data, 4 weeks|Percentage of time spent in the glucose range above 10.0 mmol/L and 13.9 mmol/L, Percent as per CGM data, 4 weeks|Mean glucose levels, Defined as per CGM data, in mmol/L, 4 weeks|Standard deviation of glucose levels, Defined as per CGM data, in mmol/L, 4 weeks|Coefficient of variance of glucose levels, Percent as per CGM data, 4 weeks|Total insulin delivery (overall, basal, and bolus), Defined as per participant's pump data, 4 weeks|Mean daily carbohydrate intake, Defined as per participant's pump data, 4 weeks|HbA1c, Percent as per blood test, 26 weeks|Estimated glomerular filtration rate (eGFR), mL/min/1.73 m\^2 as per blood test, 26 weeks|Lipid profile, Includes measurements in mmol/L as per blood test: total cholesterol, triglycerides, HDL-C, LDL-C, nonHDL-C, 26 weeks|Brain Natriuretic Peptide (NT-pro-BNP), ng/L as per blood test, 26 weeks|Liver profile - bilirubin, umol/L as per blood test, 26 weeks|Liver profile - alanine transaminase (ALT) and alkaline phosphatase (ALP), U/L as per blood test, 26 weeks|Measurement of body mass: weight and height, Body measurement as described (weight in kilograms and height in meters). Weight and height will be combined to report body mass index in kg/m\^2., 26 weeks|Waist and hip circumference, and waist-to-hip ratio, Body measurements as described (waist and hip circumference in centimeters). Waist and hip cirumference will be combined to report waist-to-hip ratio., 26 weeks|Heart rate, Body measurement as described (beats per minutes), 26 weeks|Blood pressure, Body measurement as described (diastolic and systolic pressure; mmHg), 26 weeks|Average scores between interventions based on Type 1 Diabetes Distress Scale Questionnaire, Self-report scale (1 min = "not a problem" to 6 max = "a very serious problem") that assesses a participant's distress surrounding their diabetes with higher scores correlating to higher distress., 26 weeks|Average scores between interventions based on Hypoglycemic Fear Survey - II, Likert scale (1 min to 5 max) that assesses a participant's worry surrounding hypoglycemia with higher scores indicating increased fear of hypoglycemia., 26 weeks|Average scores between interventions based on Diabetes Treatment Satisfaction Questionnaire, Self-report scale (0 min = "very dissatisfied" to 6 max = "very satisfied") that assesses a participant's satisfaction surrounding the treatment for their diabetes with higher scores indicating greater satisfaction with treatment., 26 weeks|Fasting ketone levels, As per ketone test strip and meter; measured by participant, 7 days
Sponsor/Collaborators: Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Collaborators: Diabetes Canada
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-02
Completion Date: 2025-05
Results First Posted:
Last Update Posted: 2024-08-09
Locations: McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT06021145