| Outcome Measures: |
Primary: Measured Glomerular Filtration Rate (mGFR), Change in mGFR from baseline to the end of the 16-week treatment period., 16 weeks | Secondary: Glycated Hemoglobin A1c (HbA1c), Change in HbA1c from baseline to the end of the 16-week treatment period., 16 weeks|Adverse events, Rate of adverse events reported from baseline to the end of the 16-week treatment period., 16 weeks|Diabetes Ketoacidosis (DKA), Rate of confirmed DKA events from baseline to the end of the 16-week treatment period. All reported and suspected DKA events will be reviewed for confirmation by the study's DKA Adjudication Committee., 16 weeks|Hypoglycemic events, Rate of hypoglycemic events requiring assistance from baseline to the end of the 16-week treatment period., 16 weeks|Urinary and Genitourinary Tract Infections, Rate of urinary and genitourinary tract infections reported from baseline to the end of the 16-week treatment period., 16 weeks|Blood Glucose Profile, Change in ambulatory glucose profiles (AGP) from pre-drug initiation to the end of the 16-week treatment period., 16 weeks|Glycemic Variability, Change in time-in-range (TIR) from baseline to the end of the 16-week treatment period as measured by CGM. TIR is defined as the proportion of time (in %) spent with blood glucose levels between 3.9 and 10.0 mmol/L and will be determined using CGM., 16 weeks|Weight, Change in body weight (in kg) from baseline to the end of the 16-week treatment period., 16 weeks|Body Mass Index (BMI), Change in Body Mass Index in (kg/m\<sup\>2\</sup\>) from baseline to the end of the 16-week treatment period., 16 weeks|Maturation, Assessed by Tanner pubertal staging at baseline and the end of the 16-week treatment period., 16 weeks|Total Daily Insulin Dose (TDID), Change in the total daily dose of insulin (in IU) from baseline to the end of the 16-week treatment period., 16 weeks | Other: Flow-Mediated Dilation (FMD), Change in flow mediated dilation using high resolution ultrasound from baseline to the end of the 16-week treatment period., 16 weeks|Pulse Wave Velocity (PWV), Change in pulse pressure waveforms from baseline to the end of the 16-week treatment period., 16 weeks|Heart Rate Variability (HRV), Change in heart rate variability from baseline to the end of the 16-week treatment period., 16 weeks|Caloric Intake, Change in daily caloric intake (in kcals) from baseline to the end of the 16-week treatment period., 16 weeks|Macronutrient Intake, Change in daily macronutrient intake (carbohydrates, fat, protein) in grams per kcals from baseline to the end of the 16-week treatment period., 16 weeks|Treatment Satisfaction, Assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), using a standardized scoring system., 16 weeks|Diabetes Management, Assessed using the Diabetes Management Questionnaire (DMQ) using a 20 item questionnaire with standardized scoring., 16 weeks|BOLD MRI, Changes in functional renal imaging, 16 weeks|Exercise Session - Blood Glucose Levels, Change in blood glucose levels from pre- to post-exercise from baseline to 4 weeks post-drug initiation. Participants in the optional exercise component will undergo a moderate activity exercise session and will have their blood tested before and at the end of the 60-minute session., 4 weeks|Exercise Session - Blood Glucose Variability, Change in time-in-range (TIR) during a moderate activity exercise session from baseline to 4 weeks post-drug initiation. TIR is defined as the proportion of time (in %) spent with blood glucose levels between 3.9 and 10.0 mmol/L and will be determined using CGM., 4 weeks
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| Locations: |
Children's Hospital Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|London Health Sciences Centre Children's Hospital, London, Ontario, N6A5W9, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
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