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Clinical Trial Details

Trial ID: L3208
Source ID: NCT04450563
Associated Drug: 14-Day Outpatient Intervention
Title: Low Dose Empagliflozin in Adults With Type 1 Diabetes on Closed Loop Insulin System
Acronym: CL-LoDE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: 14-day outpatient intervention
Outcome Measures: Primary: Percentage of time of plasma glucose levels spent in target range (placebo vs empagliflozin 2.5 mg), Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on closed-loop system vs. empagliflozin 2.5 mg ono closed-loop insulin system., 10 days|Percentage of time of plasma glucose levels spent in target range (placebo vs empagliflozin 5 mg), Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on closed-loop system vs. empagliflozin 5 mg ono closed-loop insulin system., 10 days | Secondary: Percentage of time spent in the following ranges of glucose levels between 3.9 and 7.8 mmol/L, 10 days (for each intervention)|Percentage of time spent in the following ranges of glucose levels: below 3.9, 3.3 and 2.8 mmol/L, 10 days|Percentage of time spent in the following ranges of glucose levels: above 7.8, 10, 13.9, and 16.7 mmol/L, 10 days|Average glucose level, 10 days|Percentage coefficient of variation of glucose levels, 10 days|Quality of life measure by Type 1 Diabetes Distress Scale: score is the average of 28 items from 1 to 6 (higher score indicates more emotional distress), 10 days|Quality of life measure by Hypoglycemic Fear Survey - II: score is the average of 33 items from 1 to 5 (average of higher scorer equates to more distress), 10 days|Quality of life measure by INSPIRE (Insulin delivery Systems: Perceptions, Ideas, Reflections and Expectations) questionnaire for adults: score is the average of 22 items from 1 to 5 (average of higher scorer equates to more distress), 10 days|Total daily insulin dose, 10 days|Average point-of-care ketone level per intervention, 10 days|Rise in ketone level between interventions, 10 days
Sponsor/Collaborators: Sponsor: McGill University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-11-02
Completion Date: 2022-01-13
Results First Posted:
Last Update Posted: 2022-10-12
Locations: Clinique Médicale Hygea, Montreal, Quebec, H4A 3T2, Canada
URL: https://clinicaltrials.gov/show/NCT04450563