Presenter of 3 Presentations
Q&A
The Value of Customization in Automated Insulin Delivery: Preschool and Beyond
PERFORMANCE OF OMNIPOD® 5 AUTOMATED INSULIN DELIVERY SYSTEM AT SPECIFIC GLUCOSE TARGETS FROM 110-150MG/DL OVER THREE MONTHS IN VERY YOUNG CHILDREN WITH TYPE 1 DIABETES
Abstract
Background and Aims
Insulin therapy should be individualized for users’ unique treatment goals. The Omnipod 5 System provides automated insulin delivery (AID) with customizable glucose targets from 110-150mg/dL (6.1-8.3mmol/L). This analysis assessed system performance at specific glucose targets during the 3-month pivotal study in very young children (aged 2-5.9y) with type 1 diabetes (T1D).
Methods
Participants with A1C<10% (86mmol/mol) used the AID system for 3 months at home after a 14-day standard therapy (ST) phase. Glucose targets from 110-150mg/dL (6.1-8.3mmol/L) in 10mg/dL (0.55mmol/L) increments were programmable by time of day. Primary safety and efficacy endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and sensor glucose percent time in target range (TIR) (70-180mg/dL, 3.9-10.0mmol/L) during AID at each glucose target compared with ST.
Results
Participants (N=80), aged (mean±SD) 4.7±1.0y with T1D duration 2.3±1.1y, had a total daily dose (TDD) of 13.7±4.4units (range 5.3-27.1units) and baseline A1C of 7.4±1.0% (57±10.9mmol/mol) (range 5.4-10.2%, 36-88mmol/mol). TIR improved during the AID phase with all targets, while time <70mg/dL (<3.9mmol/L) remained low at the 110mg/dL (6.1mmol/L) target and decreased with all other targets (Table). There was no correlation between time-weighted average target and age (r=-0.02) or TDD (r=0.05), (both p>0.05). There were no SH or DKA episodes.
Conclusions
The Omnipod 5 System was safely used by a large cohort of very young children with T1D at glucose targets from 110-150mg/dL (6.1-8.3mmol/L). The 110mg/dL (6.1mmol/L) and 120mg/dL (6.7mmol/L) targets were used most often, at a combined 75% of the time.