Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions
Sherr J, Buckingham BA, Forlenza G, Galderisi A, Ekhlaspour L, Wadwa RP, Carria L, Hsu L, Berget C, Peyser TA, Lee JB, O'Connor J, Dumais B, Huyett L, Layne JE, Ly TT. Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions. Diabetes Technology & Therapeutics 2019, 22: 174-184. PMID: 31596130, PMCID: PMC7047109, DOI: 10.1089/dia.2019.0286.Peer-Reviewed Original ResearchConceptsDaily physical activityPhysical activityFree-living conditionsPercentage timeMultiple daily injectionsType 1 diabetesRespective age groupsCohort of participantsHybrid closed-loop systemPrimary endpointDaily injectionsEligible participantsClosed-loop studiesPercentage of timeTherapy phaseInvestigational deviceNights of useAge groupsSensor glucoseType 1Home settingDlSignificant decreaseUsual routineAdults215-OR: Safety and Performance of the Omnipod Hybrid Closed-Loop System in Young Children Aged 2-6 Years with Type 1 Diabetes
BUCKINGHAM B, FORLENZA G, SHERR J, GALDERISI A, EKHLASPOUR L, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. 215-OR: Safety and Performance of the Omnipod Hybrid Closed-Loop System in Young Children Aged 2-6 Years with Type 1 Diabetes. Diabetes 2019, 68 DOI: 10.2337/db19-215-or.Peer-Reviewed Original ResearchDiabetes careMedtronic MiniMedSevere hypoglycemic eventsChildren Aged 2Advisory PanelYoung childrenMin/dAge 4.2Oral carbohydrateHybrid closed-loop systemHypoglycemic eventsGlycemic outcomesMean glucoseAged 2CGM useTherapy phaseInvestigational deviceType 1T1D therapyPercent timeMiniMedLexicon PharmaceuticalsCareUsual routineAdult participants