2024
Real-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 sample
2023
Safety 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 TBR898-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
33-OR: ADA Presidents' Select Abstract: Glycemic Outcomes over 12 Months in Very Young Children with the Omnipod 5 Automated Insulin Delivery (AID) System
DESALVO D, BODE B, FORLENZA G, LAFFEL L, BUCKINGHAM B, CRIEGO A, SCHOELWER M, MACLEISH S, SHERR J, HANSEN D, LY T. 33-OR: ADA Presidents' Select Abstract: Glycemic Outcomes over 12 Months in Very Young Children with the Omnipod 5 Automated Insulin Delivery (AID) System. Diabetes 2022, 71 DOI: 10.2337/db22-33-or.Peer-Reviewed Original ResearchDiabetic ketoacidosisSevere hypoglycemiaMannKind CorporationGlycemic outcomesExtension studyEpisodes of diabetic ketoacidosisOccurrence of severe hypoglycemiaNational Institute of DiabetesDigestive and Kidney DiseasesCenter for Health ResearchChildren aged 2Type 1 diabetesStandard therapySafety endpointsPivotal studiesPotential long-term benefitsKidney diseaseStudy groupGlucose targetsLong-term benefitsSpeakers bureauImprove glycemic outcomesAged 2MedtronicGlycemic benefits
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 eventsA1C70-OR: Evaluation of the Omnipod 5 Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes (T1D)
SHERR J, BODE B, FORLENZA G, LAFFEL L, BROWN S, BUCKINGHAM B, CRIEGO A, DESALVO D, MACLEISH S, HANSEN D, LY T. 70-OR: Evaluation of the Omnipod 5 Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes (T1D). Diabetes 2021, 70 DOI: 10.2337/db21-70-or.Peer-Reviewed Original ResearchDiabetes careDiabetic ketoacidosisStandard therapySevere hypoglycemiaSpeakers bureauEli LillyYoung childrenPrimary safety outcomePrimary effectiveness outcomeSerious adverse eventsAdvisory PanelLexicon PharmaceuticalsDaily dose requirementsType 1 diabetesNovo NordiskBoehringer Ingelheim PharmaceuticalsMannKind CorporationPermissive hyperglycemiaBaseline characteristicsHybrid closed-loop systemT1D durationAdverse eventsGlucose targetsEfficacy analysisInsulin delivery systemsSafety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Adults and Adolescents With Type 1 Diabetes (T1D)
Brown S, Levy C, Hirsch I, Bode B, Carlson A, Shah V, Pinsker J, Weinstock R, Bhargava A, Mehta S, Laffel L, Jones T, Sherr J, Aleppo G, Forlenza G, Ly T. Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Adults and Adolescents With Type 1 Diabetes (T1D). Journal Of The Endocrine Society 2021, 5: a671-a672. DOI: 10.1210/jendso/bvab048.1370.Peer-Reviewed Original ResearchStandard therapyType 1 diabetesDiabetic ketoacidosisSevere hypoglycemiaInsulin delivery systemsPivotal studiesLarge cohortTarget rangeEpisodes of DKAEpisodes of SHExtension phaseMultiple daily injectionsBurden of diseaseEnd of studyHours/dayMonths of useEffectiveness endpointBaseline A1CHybrid closed-loop systemPrevious therapyPrior therapyT1D durationGlucose targetsInsulin needsDaily injectionsSafety 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
1296-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Children Aged 2-12 Years without Increasing Risk of Hypoglycemia
SHERR J, BUCKINGHAM B, FORLENZA G, GALDERISI A, EKHLASPOUR L, WADWA R, ZGORSKI M, KINGMAN R, BERGET C, LEE J, OCONNOR J, DUMAIS B, VIENNEAU T, HUYETT L, LY T. 1296-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Children Aged 2-12 Years without Increasing Risk of Hypoglycemia. Diabetes 2020, 69 DOI: 10.2337/db20-1296-p.Peer-Reviewed Original ResearchDiabetes careGlucose targetsEli LillySerious adverse eventsHigh-fat mealRisk of hypoglycemiaAdvisory PanelType 1 diabetesChildren Aged 2MannKind CorporationHybrid closed-loop systemT1D durationAdverse eventsT1D ExchangeFat mealGlucose managementMean glucosePivotal studiesAged 2Bolus challengeDaily exerciseInvestigational deviceDlPercent timeTarget glucose978-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Adults and Adolescents without Increasing Risk of Hypoglycemia
FORLENZA G, BUCKINGHAM B, SHERR J, WADWA R, GALDERISI A, EKHLASPOUR L, BERGET C, HSU L, ZGORSKI M, LEE J, OCONNOR J, DUMAIS B, VIENNEAU T, HUYETT L, LY T. 978-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Adults and Adolescents without Increasing Risk of Hypoglycemia. Diabetes 2020, 69 DOI: 10.2337/db20-978-p.Peer-Reviewed Original ResearchDiabetes careMeal bolusEli LillyPercent timeRisk of hypoglycemiaAdvisory PanelType 1 diabetesHigh-fat dinnerMannKind CorporationHybrid closed-loop systemT1D durationGlucose targetsT1D ExchangeGlucose managementPivotal studiesDaily exerciseInvestigational deviceDlTarget glucoseCareLexicon PharmaceuticalsMedtronicBolusLower targetsAdults