P-139: Performance of a NEXT-generation algorithm for a tubeless automated insulin delivery system in children with type 1 diabetes: findings from the STRIVE randomized trial
G Forlenza, D DeSalvo, L Laffel, A Criego, K Castorino, S MacLeish, D Raghinaru, R Beck, T Ly, J Sherr, , STRIVE ConsortiumAbstract
Introduction
A recent randomized crossover trial compared a next-generation algorithm for Omnipod (Omnipod 6) with the first-generation Omnipod® 5 Automated Insulin Delivery System in a diverse population including adults (T1D/T2D) and children (T1D).
Objectives
This subgroup analysis assessed safety and efficacy within the vulnerable population of children with T1D who face elevated hypoglycemia risk.
Methods
This multicenter, randomized, crossover study compared Omnipod 6 at a 100mg/dL (5.6mmol/L) target with Omnipod 5 at a 110mg/dL (6.1mmol/L) target (4 weeks each) in current Omnipod 5 users. Users continued use of Omnipod 6 for an additional 4 weeks in a restricted bolus phase (goal of ≤3 boluses/day). Safety and efficacy outcomes were evaluated in children ages 2-<6 and 6-<14y.
Results
Children aged 2-<6y (n=29; age: 4±1y, baseline A1C: 7.0±0.8%) and 6-<14y (n=36; age: 11±2y, baseline A1C: 7.0±0.8%) with T1D were randomly assigned. The 100mg/dL target was used 82% and 95% of time in the 2-<6y and 6-<14y groups, respectively, with Omnipod 6. Time in tight range (70-140mg/dL) increased by 5.5% (+1.3h/d) with Omnipod 6 in those aged 6-<14y with no significant change in those aged 2-<6y. Time <54 and <70mg/dL remained low in both groups, meeting the non-inferiority margins of 0.75% and 3%, respectively (Table). A total of 63 children entered and completed the restricted bolus phase. TIR and TITR remained high with less boluses per day and algorithm insulin delivery increasing by a mean treatment group difference of 6% (4%, 8%) and 5% (2%, 7%), both p<0.001, vs. the Omnipod 6 phase in children 2-<6y and 6-<14y, respectively. No severe hypoglycemia or DKA events occurred.
Conclusions
These results demonstrate safety and strong efficacy potential of the next-generation Omnipod 6 algorithm in children with T1D as young as 2y.