2019
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
2018
Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adolescents with Type 1 Diabetes over Five Days Under Free-Living Conditions
FORLENZA G, BUCKINGHAM B, SHERR J, PEYSER T, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adolescents with Type 1 Diabetes over Five Days Under Free-Living Conditions. Diabetes 2018, 67 DOI: 10.2337/db18-1376-p.Peer-Reviewed Original ResearchModerate-intensity exerciseDiabetes careGlycemic outcomesFree-living conditionsType 1 diabetesMin/dAdvisory PanelHybrid closed-loop systemStandard therapyDays of useEligible participantsAge 14.3Percentage of timeCGM useInvestigational deviceMedtronic MiniMedType 1DlTime 70Usual routineCareEli LillyOmnipodAdolescentsConcomitant reductionSafety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Aged 6-12 Years with Type 1 Diabetes over Five Days Under Free-Living Conditions
SHERR J, FORLENZA G, BUCKINGHAM B, PEYSER T, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Aged 6-12 Years with Type 1 Diabetes over Five Days Under Free-Living Conditions. Diabetes 2018, 67 DOI: 10.2337/db18-1377-p.Peer-Reviewed Original ResearchModerate-intensity exerciseDiabetes careGlycemic outcomesFree-living conditionsType 1 diabetesChildren Aged 6Min/dAdvisory PanelAge 9.9Hybrid closed-loop systemStandard therapyDays of useEligible participantsPercentage of timeCGM useAged 6Investigational deviceMedtronic MiniMedType 1DlTime 70Usual routineCareEli LillyOmnipodSafety and Performance of the Omnipod® Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions
BUCKINGHAM B, SHERR J, FORLENZA G, PEYSER T, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions. Diabetes 2018, 67 DOI: 10.2337/db18-207-or.Peer-Reviewed Original ResearchModerate-intensity exerciseDiabetes careGlycemic outcomesFree-living conditionsType 1 diabetesMin/dAdvisory PanelHybrid closed-loop systemStandard therapyDays of useEligible participantsPercentage of timeCGM useInvestigational deviceMedtronic MiniMedType 1DlTime 70Usual routineCareEli LillyOmnipodAdultsConcomitant reductionDays