| Trial ID: | L5747 |
| Source ID: | NCT03510000
|
| Associated Drug: |
Empagliflozin 25mg
|
| Title: |
Alleviating Carbohydrate-Counting Burden in T1DM Using Artificial Pancreas and Empagliflozin
|
| Acronym: |
CLASS15
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type1diabetes
|
| Interventions: |
DRUG: Empagliflozin 25mg|DEVICE: Single hormone artificial pancreas|BEHAVIORAL: Meal strategies
|
| Outcome Measures: |
Primary: Comparison of mean glucose levels between artificial pancreas (AP) with empagliflozin with no-meal announcement meal approach strategy and AP without empagliflozin with carb-counting meal approach strategy., Non-inferiority comparison of mean 14-hour glucose level obtained by continuous glucose monitoring between i) the AP with empagliflozin with no meal-announcement and ii) the AP with quantitative carbohydrate-counting without empagliflozin., After completing 5 meal interventions (3-9 weeks)|Comparison of mean glucose levels between AP with empagliflozin with simple meal announcement strategy and AP without empagliflozin with carb-counting., If there is a significant difference in the previous non-inferiority comparison, the following conditional primary comparison will be conducted: Non-inferiority comparison of mean 14-hour sensor glucose level obtained by continuous glucose monitoring between i) the AP with empagliflozin with simple meal-announcement and ii) the AP with quantitative carbohydrate-counting without empagliflozin., After completing 5 meal interventions (3-9 weeks) | Secondary: Time spent in hypoglycemia, Percentage of time spent in the following glucose sensor levels: 1. Between 3.9 and 10.0 mmol/l 2. Between 3.9 and 7.8 mmol/l 3. Above 7.8 mmol/l 4. Above 10.0 mmol/l 5. Above 13.9 mmol/l 6. Below 3.9 mmol/l 7. Below 3.3 mmol/l 8. Below 2.8 mmol/l., After completing 5 meal interventions (3-9 weeks)|Number of hypoglycemic events below 3.3 mmol/L, Number of hypoglycemic events (\> 20 minutes) below 3.3 mmol/L based on continuous glucose monitoring sensor glucose level values., After completing 5 meal interventions (3-9 weeks)|Number of clinically remarkable hypoglycemic events, Number of symptomatic hypoglycemic events below 4.0 mmol/l or below 3.5 mmol/l without symptoms., After completing 5 meal interventions (3-9 weeks)|Number of treated hypoglycemic events, Number of hypoglycemic events or events perceived as hypoglycemia which prompt treatment by glucose or glucagon or overriding AP insulin dosing algorithm suggestion or by administering the regular meal earlier than planned., After completing 5 meal interventions (3-9 weeks)|Mean continuous glucose monitoring (CGM) glucose level, Comparison of mean CGM glucose levels between different meal interventions on and off empagliflozin., After completing 5 meal interventions (3-9 weeks)|Standard deviation of glucose levels, Comparison of values obtained from CGM on different meal intervention days., After completing 5 meal interventions (3-9 weeks)|Coefficient of variation of glucose levels, Comparison of values obtained from CGM on different meal intervention days., After completing 5 meal interventions (3-9 weeks)|Total insulin delivery, Comparison of total insulin delivered by AP on different meal intervention days., After completing 5 meal interventions (3-9 weeks)|Morning capillary ketone concentration, Safety outcome to assess risk of Empagliflozin related most serious side effect-diabetic ketoacidosis. Evaluated will be all days of study participation (i.e.not only meal intervention days), After completing 5 meal interventions (3-9 weeks)
|
| Sponsor/Collaborators: |
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Collaborators: Canadian Diabetes Association|Institut de Recherches Cliniques de Montreal|McGill University Health Centre/Research Institute of the McGill University Health Centre
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-05-15
|
| Completion Date: |
2019-11-21
|
| Results First Posted: |
|
| Last Update Posted: |
2021-06-24
|
| Locations: |
Sinai Health System, Toronto, Ontario, M5T 3L9, Canada|Institut de recherches cliniques de Montréal, Montréal, Quebec, H2W 1R7, Canada|McGill University Health Center, Montréal, Quebec, H3A 2B4, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03510000
|
