Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D)
Buckingham B, Forlenza G, Criego A, Hansen D, Bode B, Brown S, MacLeish S, Pinsker J, DeSalvo D, Sherr J, Mehta S, Laffel L, Bhargava A, Ly T. Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D). Journal Of The Endocrine Society 2021, 5: a454-a454. PMCID: PMC8090047, DOI: 10.1210/jendso/bvab048.927.Peer-Reviewed Original ResearchDiabetic ketoacidosisSevere hypoglycemiaPercentage of timePivotal studiesLarge cohortEpisodes of DKAEpisodes of SHExtension phaseTarget rangeType 1 diabetesEnd of studyHours/dayMonths of useBaseline A1CEffectiveness endpointHybrid closed-loop systemNeurologic outcomePrevious therapyT1D durationStandard therapyGlucose targetsPediatric populationPrimary safetyGlycemic outcomesTreatment paradigm