O-26: Glycemic outcomes with a tubeless automated insulin delivery (AID) system in infants and toddlers <2 years of age: evidence from Real-World users
J Wood, D DeSalvo, G Forlenza, D Do, L Huyett, K Miller, T LyAbstract
Introduction
The Omnipod 5 System is indicated for use in individuals with T1D aged ≥2 years. Infants and toddlers <2 years old, who are highly insulin-sensitive and vulnerable to glycemic variability, remain outside current indications despite potential AID benefits, partly due to limited data.
Objectives
Understand real-world Omnipod 5 System use among this vulnerable population.
Methods
We analyzed real-world CGM and insulin delivery data from Omnipod 5 System users <2 years of age with T1D in the U.S., between January 1, 2022 to July 30, 2025. Outcomes were evaluated in users with sufficient CGM data (≥14 days with ≥1 reading and ≥75% of days with ≥220 readings) inclusive of data up to 1 day before their 2nd birthday.
Results
Data from 288 users were analyzed (mean±SD age: 11±2.4 months, TDI: 7.9U/day). Average target glucose settings of 110mg/dL, 120mg/dL, 130mg/dL, 140mg/dL, and 150mg/dL were utilized by 4%, 14%, 25%, 26%, and 31% of users, respectively, and users spent a median 89% of time in Automated Mode. Median time spent in level 1 (<70mg/dL) and level 2 (<54mg/dL) hypoglycemia was <1%, with 98% and 94% of users meeting the clinical targets of <4% and <1%, respectively. Median time in range (TIR, 70-180mg/dL) was 49% overall and was 63% among those using the lowest targets of 110 or 120mg/dL (Table).
Conclusions
These real-world findings demonstrate the safe use of Omnipod 5 in infants and toddlers, with minimal hypoglycemia, underscoring the value of customizable glucose targets in this unique, challenging to manage population.