Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Diabetes Canada | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is:
- Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets?
Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 2.5 mg daily | Experimental | Empagliflozin is a sodium/glucose cotransporter 2 inhibitor (SGLT2i) that inhibits glucose reabsorption in the kidney. In this study, a capsule of empagliflozin 2.5 mg will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks. |
|
| Placebo | Active Comparator | As a control, a placebo capsule will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | 26-week use of automated insulin delivery system with empagliflozin (2.5 mg daily) in individuals with suboptimal time in range. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adelyn Moore | Contact | (438) 866-4807 | adelyn.moore@mail.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Melissa-Rosina Pasqua, MD | Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 26-week use of automated insulin delivery system with placebo (daily) in individuals with suboptimal time in range. |
|
| 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided