2021
Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT, Brown S, Voelmle M, Emory E, Forlenza G, Wadwa R, Slover R, Cobry E, Messer L, Berget C, McCoy S, Shah V, Akturk H, Schneider N, Joseph H, Joshee P, Beatson C, Bode B, Narron B, Lopez T, Pinsker J, Church M, Castorino K, Piper M, Perez J, Levy C, Lam D, Levister C, O’Malley G, Ogyaadu S, Arasaratnam D, Plesser M, Nosova E, Bzdick S, Hansen D, Stone S, Weinstock R, Hirsch I, Trikudanathan S, Sanborn N, Khakpour D, Carlson A, Criego A, Bergenstal R, Martens T, Grieme A, Hyatt J, Punel A, Whipple D, Sherr J, Van Name M, Brei M, Zgorski M, Steffen A, Carria L, Mehta S, Laffel L, Roethke L, Fisher M, La Banca R, Volkening L, Ambler-Osborn L, Turcotte C, Freiner E, Bhargava A, Borg L, MacLeish S, Wood J, Kaminski B, Casey T, Campbell W, DeSalvo D, McKay S, DeLaO M, Villegas C, Jones T, Johns B, Gore A, Harvill L, Merritt K, Stanfield J, Sheldon J, Hichkad L, Burnett E, Castelot A, Bounds L, Preston K, Goldfaden R, Aleppo G, Kravarusic J, Bansal A, Buckingham B, Ekhlaspour L, Kingman R, Kivilaid K, Kleve K, Ly T, Dumais B, Vienneau T, Huyett L, Lee J, O’Connor J, Benjamin E. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care 2021, 44: 1630-1640. PMID: 34099518, PMCID: PMC8323171, DOI: 10.2337/dc21-0172.Peer-Reviewed Original ResearchConceptsInsulin delivery systemsGlycemic targetsDiabetic ketoacidosis eventsPrimary safety outcomePrimary effectiveness outcomeSevere hypoglycemia eventsTarget glucose rangeBurden of diseaseType 1 diabetesPivotal safety studiesKetoacidosis eventsDiabetic ketoacidosisStandard therapyMulticenter trialSevere hypoglycemiaDelivery systemProspective studyHypoglycemia eventsTreatment paradigmAutomated Insulin Delivery SystemsSafety outcomesEffectiveness outcomesTherapy phaseSensor glucoseType 1
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