2024
270-OR: Real-World Outcomes with the Omnipod 5 Automated Insulin Delivery (AID) System for >7,500 Users with High HbA1c (>9%) at Baseline
FORLENZA G, SHERR J, DESALVO D, ALEPPO G, WILMOT E, BERGET C, HUYETT L, HADJIYIANNI I, MENDEZ J, CONROY L, LY T. 270-OR: Real-World Outcomes with the Omnipod 5 Automated Insulin Delivery (AID) System for >7,500 Users with High HbA1c (>9%) at Baseline. Diabetes 2024, 73 DOI: 10.2337/db24-270-or.Peer-Reviewed Original ResearchGlycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod® 5 Automated Insulin Delivery System
DeSalvo D, Bode B, Forlenza G, Laffel L, Buckingham B, Criego A, Schoelwer M, MacLeish S, Sherr J, Hansen D, Ly T. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod® 5 Automated Insulin Delivery System. Diabetes Technology & Therapeutics 2024, 26: 383-393. PMID: 38277156, DOI: 10.1089/dia.2023.0506.Peer-Reviewed Original ResearchType 1 diabetesExtension phaseEpisodes of diabetic ketoacidosisEpisodes of severe hypoglycemiaLong-term safetyLong-term useStandard therapyDiabetic ketoacidosisAutomated insulin deliverySevere hypoglycemiaYoung childrenConclusion:</i></b>Continuous glucose monitoring metricsExtension studyMethods:</i></b>MonthsGlycemic outcomesTarget rangeTrialsOmnipodHbA1cInsulin deliveryDelivery systemInsulin delivery systemsEpisodesReal-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes
Forlenza G, DeSalvo D, Aleppo G, Wilmot E, Berget C, Huyett L, Hadjiyianni I, Méndez J, Conroy L, Ly T, Sherr J. Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technology & Therapeutics 2024, 26: 514-525. PMID: 38375861, DOI: 10.1089/dia.2023.0578.Peer-Reviewed Original ResearchGlucose targetsType 1 diabetesSubgroup analysisGlycemic outcomesReal-world evidenceMultiple daily injectionsYounger age groupsBaseline characteristicsDaily injectionsRetrospective analysisClinical trialsMedian percentageAge groupsResults:</i></b>OmnipodDelivery systemOutcomesInsulin delivery systemsT1DSubgroupsDiverse sampleReal-World Evidence of Automated Insulin Delivery System Use
Considine E, Sherr J. Real-World Evidence of Automated Insulin Delivery System Use. Diabetes Technology & Therapeutics 2024, 26: 53-65. PMID: 38377315, PMCID: PMC10890954, DOI: 10.1089/dia.2023.0442.Peer-Reviewed Original ResearchConceptsGlucose management indicatorAid useRetrospective real-world studyMode of insulin deliveryGlycemic benefitsFollow-up periodTrial findingsFood and Drug AdministrationStandard of careReal-world studyInsulin deliveryType 1 diabetesNonpregnant individualsPivotal trialsRetrospective analysisPrimary outcomeHemoglobin A1cConclusion:</i></b>Drug AdministrationInclusion criteriaHbA1cGlycemic outcomesSystematic reviewResults:</i></b>Target range
2023
Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes
Criego A, Carlson A, Brown S, Forlenza G, Bode B, Levy C, Hansen D, Hirsch I, Bergenstal R, Sherr J, Mehta S, Laffel L, Shah V, Bhargava A, Weinstock R, MacLeish S, DeSalvo D, Jones T, Aleppo G, Buckingham B, Ly T, Group F. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 26: 11-23. PMID: 37850941, PMCID: PMC10794844, DOI: 10.1089/dia.2023.0364.Peer-Reviewed Original ResearchConceptsAdolescents/adultsPivotal trialsInsulin delivery systemsSingle-arm multicenter trialYears of useClinical trial registrationType 1 diabetesLong-term safetyMonths of useLong-term useDiabetic ketoacidosisMulticenter trialSevere hypoglycemiaTRIAL REGISTRATIONGlycemic outcomesType 1Delivery systemExtension phaseMonthsTrialsTarget rangeAdultsHbA1cChildrenEpisodesContinuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12‐Month Follow‐Up Results
Miller K, Bauza C, Kanapka L, Clements M, DeSalvo D, Hood K, Messer L, Sherr J, Bergamo K, Criego A, Freiner E, Lyons S, Monzavi R, Moore W, Prahalad P, Simmons J, Sulik M, Wadwa R, Weinstock R, Willi S, Williams K, Laffel L, Group F. Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12‐Month Follow‐Up Results. Pediatric Diabetes 2023, 2023: 1-12. DOI: 10.1155/2023/6718115.Peer-Reviewed Original ResearchType 1 diabetesMedian percent timeUse of CGMBlood glucose monitoringYoung adultsCGM initiationExtension phaseGlucose monitoringPercent timeContinuous glucose monitoringMean hemoglobinGlycemic controlCGM groupUp ResultsClinical trialsGlycemic outcomesGlycemic benefitsCGM useMonitoring interventionsType 1Further evaluationBGM groupWeeksDlAdultsSafety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes
Pihoker C, Shulman D, Forlenza G, Kaiserman K, Sherr J, Thrasher J, Buckingham B, Kipnes M, Bode B, Carlson A, Lee S, Latif K, Liljenquist D, Slover R, Dai Z, Niu F, Shin J, Jonkers R, Roy A, Grosman B, Vella M, Cordero T, McVean J, Rhinehart A, Vigersky R, Bode B, Buckingham B, Carlson A, Casaubon L, Christiansen M, Cordero T, Garg S, Grosman B, Kaiserman K, Kipnes M, Latif K, Lee S, Liljenquist D, Lintereur L, Liu M, McVean J, Parikh N, Peng F, Pihoker C, Philis-Tsimikas A, Pop-Busui R, Reed J, Rhinehart A, Roy A, Sherr J, Shin J, Shulman D, Singh K, Slover R, Thrasher J, Vella M, Vigersky R, Wu D. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 25: 755-764. PMID: 37782145, DOI: 10.1089/dia.2023.0255.Peer-Reviewed Original ResearchConceptsDiabetic ketoacidosisSensor glucosePivotal trialsSevere hypoglycemiaPredictive low glucose managementSingle-arm studySensor-augmented pumpType 1 diabetesEnd of studyMean sensor glucoseEffectiveness endpointTreat populationGlycemic targetsGlucose targetsInvestigational centersPrimary safetyGlycemic outcomesMean TIRA1CType 1Higher TIRStudy periodClosed-loop useCoefficient of variationLower TBRPsychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers
Hood K, Polonsky W, MacLeish S, Levy C, Forlenza G, Criego A, Buckingham B, Bode B, Hansen D, Sherr J, Brown S, DeSalvo D, Mehta S, Laffel L, Bhargava A, Huyett L, Vienneau T, Ly T. Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers. Pediatric Diabetes 2023, 2023: 1-12. DOI: 10.1155/2023/8867625.Peer-Reviewed Original ResearchType 1 diabetesGlycemic outcomesInsulin delivery systemsPsychosocial outcomesSleep qualityDiabetes-related distressCaregivers of childrenRegression analysisBaseline characteristicsDelivery systemProspective studyClinical trialsLinear regression analysisPsychosocial measuresParticipant characteristicsDiabetesCaregiversOutcomesOmnipodChildrenAdolescentsTrialsMonthsAdditional benefitSignificant improvement898-P: Real-World Glycemic Outcomes of >3,300 Children and Adolescents with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management
SHERR J, DESALVO D, HUYETT L, SNOW K, MENDEZ J, HADJIYIANNI I, LY T. 898-P: Real-World Glycemic Outcomes of >3,300 Children and Adolescents with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management. Diabetes 2023, 72 DOI: 10.2337/db23-898-p.Peer-Reviewed Original ResearchCloud-based data managementCloud-based data management systemsJuvenile Diabetes Research FoundationType 1 diabetesUploading of dataNational Institutes of HealthData management systemAge groupsEvaluate real-world outcomesContinuous glucose monitoringGlycemic outcomesAutomatic uploadCloud-basedData managementReal worldUsersMedian timePersonalized therapyGlucose targetsManagement systemInstitutes of HealthTime of analysisReal-world outcomesMedtronicSystem use
2022
Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial
Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT, Sherr J, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode B, Busby A, Forlenza G, Wadwa R, Slover R, Cobry E, Messer L, Laffel L, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown S, Krauthause K, Emory E, Oliveri M, Buckingham B, Ekhlaspour L, Kingman R, Criego A, Schwartz B, Gandrud L, Grieme A, Hyatt J, DeSalvo D, McKay S, DeLaO K, Villegas C, MacLeish S, Wood J, Kaminski B, Casey T, Campbell W, Behm K, Adams R, Hansen D, Stone S, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly T, Dumais B, Vienneau T, Huyett L, Lee J, O’Connor J, Benjamin E. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care 2022, 45: 1907-1910. PMID: 35678724, PMCID: PMC9346983, DOI: 10.2337/dc21-2359.Peer-Reviewed Original ResearchConceptsInsulin delivery systemsSingle-arm studyLong-term complicationsMulticenter clinical trialType 1 diabetesSensor glucose levelsYoung childrenBaseline data collectionReduced hypoglycemiaDiabetic ketoacidosisGlycemic targetsUsual therapyGlycemic measuresSevere hypoglycemiaDelivery systemStudy endGlycemic outcomesClinical trialsGlucose levelsType 1HypoglycemiaInvestigational systemDlChildrenStudy phaseHow introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System
Polonsky WH, Hood KK, Levy CJ, MacLeish SA, Hirsch IB, Brown SA, Bode BW, Carlson AL, Shah VN, Weinstock RS, Bhargava A, Jones TC, Aleppo G, Mehta SN, Laffel LM, Forlenza GP, Sherr JL, Huyett LM, Vienneau TE, Ly TT, Group F. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System. Diabetes Research And Clinical Practice 2022, 190: 109998. PMID: 35853530, PMCID: PMC10901155, DOI: 10.1016/j.diabres.2022.109998.Peer-Reviewed Original ResearchConceptsType 1 diabetesPsychosocial outcomesTreatment satisfactionInsulin delivery systemsSleep qualityPsychosocial measuresParticipant characteristicsBaseline participant characteristicsDiabetes distressGlycemic outcomesProspective safetyEfficacy studiesLinear regression analysisDelivery systemAid useAdultsOutcomesOmnipodT1D.DiabetesRegression analysisMonthsSignificant improvementDistressMulticenter
2021
Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes
Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2021, 24: 178-189. PMID: 34694909, PMCID: PMC8971997, DOI: 10.1089/dia.2021.0319.Peer-Reviewed Original ResearchConceptsAdvanced hybrid closed-loop systemMulticenter single-arm studyPredictive low glucose managementDiabetic ketoacidosis eventsSingle-arm studySensor-augmented pumpType 1 diabetesWilcoxon signed-rank testStudy phaseKetoacidosis eventsTreat populationHybrid closed-loop systemMean A1CGlycemic targetsGlucose targetsPivotal trialsStudy endpointGlucose managementGlycemic outcomesSigned-rank testAge groupsStudy participantsType 1Safety eventsA1CSafety 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
2020
Changes in Device Uptake and Glycemic Control Among Pregnant Women With Type 1 Diabetes: Data From the T1D Exchange
Levy CJ, Foster NC, DuBose SN, Agarwal S, Lyons SK, Peters AL, Uwaifo GI, DiMeglio LA, Sherr JL, Polsky S. Changes in Device Uptake and Glycemic Control Among Pregnant Women With Type 1 Diabetes: Data From the T1D Exchange. Journal Of Diabetes Science And Technology 2020, 15: 1297-1302. PMID: 33218278, PMCID: PMC8655289, DOI: 10.1177/1932296820972123.Peer-Reviewed Original ResearchConceptsContinuous subcutaneous insulin infusionPregnant womenEligible participantsCohort 2Continuous glucose monitorGlycemic outcomesT1D Exchange Clinic RegistryDevice useSubcutaneous insulin infusionHemoglobin A1c resultsT1D pregnancyGlycemic controlClinic registryT1D ExchangeCSII useA1C resultsInsulin infusionMedical recordsCohort 1CGM useType 1Device uptakeWomenSurvey completionAdditional evaluation
2019
215-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