Safety and Glycemic Outcomes Among Youth With New‐Onset Type 1 Diabetes Using a Tubeless Automated Insulin Delivery System

INTRODUCTION: Automated insulin delivery (AID) systems aim to safely optimize glycemic outcomes; however, data in the new-onset type 1 diabetes (T1D) period are limited. We evaluated safety and glycemic outcomes of Omnipod 5 AID System use in the new-onset period. METHODS: This was a retrospective observational analysis of youth at a single center who initiated Omnipod 5 within 90 days of T1D diagnosis. Safety outcomes included diabetic ketoacidosis (DKA) and severe hypoglycemia. Continuous glucose monitoring (CGM) metrics and insulin delivery data were analyzed across the first 3 months of use and between pediatric age groups (<6-year-olds, 6 to <12-year-olds, and 12 to <18-year-olds). RESULTS: Among 74 youth initiating Omnipod 5 within 90 days of T1D diagnosis, there was no occurrence of DKA or severe hypoglycemia in the first 3 months of AID system use. The time-weighted average glucose target value on the device setting was 118.8 mg/dL (6.6 mmol/L) with a median of 97% time in Automated Mode over 3 months. Median total daily insulin was 7.4 units (45.5% basal) in <6-year-olds, 11.4 units (48% basal) in 6 to <12-year-olds, and 25.7 units (45% basal) in 12 to <18-year-olds. The median glucose management indicator (GMI) was 7.1% (54 mmol/mol) and time in range (70-180 mg/dL, 3.9-10.0 mmol/L) was 72.1% with minimal hypoglycemia: 1.0% Level 1 time below range (TBR, 54-69 mg/dL, 3.0-3.8 mmol/L) and 0% Level 2 TBR (<54 mg/dL, <3.0 mmol/L). CONCLUSION: These real-world observational data from youth with new-onset T1D using a tubeless AID system indicate safety and favorable glycemic outcomes with AID system initiation early after diagnosis. Future studies should assess the long-term glycemic and quality of life impact of early AID system adoption.