Outcome Measures: |
Primary: Time-in-serious hypoglycemia, % spent less than 54mg/dl, averaged across all daily measures averaged across two CGM sensors, 6 months after randomization|Time-in-range (TIR), % between 70 and 180mg/dl inclusive, averaged across two CGM sensors, 6 months after randomization | Secondary: Time-in-hypoglycemia, % spent less than 70mg/dl, 6 months after randomization|Time-above-range, % spent greater than 180mg/dl, 6 months after randomization|Nocturnal hypoglycemic events, Number of events (defined as \>=15mins in duration \< 70mg/dl) between 1200 and 0600, 6 months after randomization|Glycemic control (HbA1c), Mean HbA1c lab result, baseline, 3, 6, 9 and 12 months after randomization|Rate of severe hypoglycemic events, Events requiring the assistance of an external third party person, 6 months after randomization|Rate of Diabetic Ketoacidosis, Hospitalization or Emergency Room Visit with primary diagnosis of Diabetic Ketoacidosis. This will be measured by self-report and confirmed through review of hospital records, 6 months after randomization|Quality of Life (e.g. PedsQL Pediatric Quality of Life Inventory), The PedsQLTM 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years. Items are scaled on a 5-point scale from 0 (never) to 4 (almost always). Scores are transformed on a scale range from 0 to 100. The total score is the sum of all the items over the number of items answered on all scales., Baseline and at 6 and 12 months after randomization
|