2024
326-OR: Activity Feature Attenuates Drop in Glucose for Individuals with Type 1 Diabetes Using Omnipod 5 Automated Insulin Delivery System
TURNER L, SHERR J, ZAHARIEVA D, BARAN J, BODE B, BROWN S, BZDICK S, MEI CHURCH M, HANSEN D, KINGMAN R, LAFFEL L, SHAH V, STONE S, VIENNEAU T, HUYETT L, DUMAIS B, LY T, RIDDELL M, 5 EXERCISE RESEARCH GROUP O. 326-OR: Activity Feature Attenuates Drop in Glucose for Individuals with Type 1 Diabetes Using Omnipod 5 Automated Insulin Delivery System. Diabetes 2024, 73 DOI: 10.2337/db24-326-or.Peer-Reviewed Original ResearchGeneralized estimating equationsInternational Society for Pediatric and Adolescent DiabetesActivity sessionsEstimating equationsType 1 diabetesExerciseAdolescent DiabetesAF-30Glucose declineDeliveryInsulin deliveryInsuletSessionsDelivery systemInsulin delivery systemsDiabetesAutomated deliveryOmnipodRiskGlucoseT1DPeopleGlycemic 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 sample
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 rangeAdultsHbA1cChildrenEpisodesPsychosocial 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 improvementDiabetes Technology Meeting 2022
Huang J, Yeung A, DuBord A, Wolpert H, Jacobs P, Lee W, Drincic A, Spanakis E, Sherr J, Prahalad P, Fleming A, Hsiao V, Kompala T, Lal R, Fayfman M, Ginsberg B, Galindo R, Stuhr A, Chase J, Najafi B, Masharani U, Seley J, Klonoff D. Diabetes Technology Meeting 2022. Journal Of Diabetes Science And Technology 2023, 17: 1085-1120. PMID: 36704821, PMCID: PMC10347991, DOI: 10.1177/19322968221148743.Peer-Reviewed Case Reports and Technical NotesConceptsDiabetes technologyPainful diabetic neuropathyDiabetic foot ulcersSpinal cord stimulationContinuous glucose monitoringElectronic health recordsDiabetic neuropathyFoot ulcersCord stimulationDiabetes careInsulin delivery systemsInsulin pensMeasurement of glucoseGlucose monitor dataGlucose monitoringInsulin deliveryHealth recordsContinuous glucose monitor dataNovel insulinInsulinDelivery systemDigital healthNeuropathyHypoglycemiaUlcers
2022
Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association
Sherr JL, Heinemann L, Fleming GA, Bergenstal RM, Bruttomesso D, Hanaire H, Holl RW, Petrie JR, Peters AL, Evans M. Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetologia 2022, 66: 3-22. PMID: 36198829, PMCID: PMC9534591, DOI: 10.1007/s00125-022-05744-z.Peer-Reviewed Original ResearchConceptsAmerican Diabetes AssociationStudy of DiabetesDiabetes AssociationEuropean AssociationConsensus reportClinical careInsulin pumpInsulin deliveryIntensive insulin therapyType 1 diabetesManagement of diabetesRegulatory approvalContinuous glucose monitoringWorking GroupInsulin therapyInsulin delivery systemsDiabetesGlucose monitoringGlucose dataInternal review processAssociationSensor glucose dataCareReportGroupAutomated Insulin Delivery: Benefits, Challenges, and Recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.
Sherr JL, Heinemann L, Fleming GA, Bergenstal RM, Bruttomesso D, Hanaire H, Holl RW, Petrie JR, Peters AL, Evans M. Automated Insulin Delivery: Benefits, Challenges, and Recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetes Care 2022, 45: 3058-3074. PMID: 36202061, DOI: 10.2337/dci22-0018.Peer-Reviewed Original ResearchConceptsAmerican Diabetes AssociationStudy of DiabetesDiabetes AssociationEuropean AssociationConsensus reportClinical careInsulin pumpInsulin deliveryIntensive insulin therapyType 1 diabetesManagement of diabetesRegulatory approvalContinuous glucose monitoringWorking GroupInsulin therapyInsulin delivery systemsDiabetesGlucose monitoringGlucose dataInternal review processAssociationSensor glucose dataCareReportGroupSafety 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 improvementDistressMulticenterClinical Implementation of the Omnipod 5 Automated Insulin Delivery System: Key Considerations for Training and Onboarding People With Diabetes
Berget C, Sherr JL, DeSalvo DJ, Kingman RS, Stone SL, Brown SA, Nguyen A, Barrett L, Ly TT, Forlenza GP. Clinical Implementation of the Omnipod 5 Automated Insulin Delivery System: Key Considerations for Training and Onboarding People With Diabetes. Clinical Diabetes 2022, 40: 168-184. PMID: 35669307, PMCID: PMC9160549, DOI: 10.2337/cd21-0083.Peer-Reviewed Original ResearchInsulin delivery systemsDiabetes specialty clinicPrimary care providersPrimary care settingContinuous glucose monitoring systemTherapeutic burdenDelivery systemGlucose monitoring systemDiabetes careSpecialty clinicCare settingsCare providersDiabetesInsulin pumpInsulin deliveryClinical implementationGlycemic dataGlycemiaClinicTherapyAid technologyCliniciansCare
2021
Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System
DuBose SN, Bauza C, Verdejo A, Beck RW, Bergenstal RM, Sherr J, Levy C, Levister C, Lam D, O'Malley G, Ogyaadu S, Lovett J, Abram V, Kudva Y, McCrady Spitzer S, Reid C, Kumari K, Dadlani V, Goland R, Pollak S, Alvarez A, Zagoren E, Deliard J, Kruger D, Hunter H, Smith A, Remtema H, Hiers P, Albanese-O'Neill A, Haller M, Adams J, Greco M, Peters A, Harmel M, Weinstock R, Bzdick S, Bulger J, Agonstini L, Conboy P, Doolittle S, Aleppo G, Bansal A, Thompson M, Arsiniega E, Hubacz L, Monzavi R, Raymond J, Brimberry D, Torres Sanchez A, Simmons J, Rainer K, Brendle F, Williams G, Kelley J, Clements M, McDonough R, Watkins D, Elrod A, Seuferling B, Harding H, James J, Orlich S, Raman V, Foster C, Davis C, Slater H, Ocanovic Z, Kingery S, Wintergerst K, Watson S, Eubanks S, Pierce G, Rush H, Wong J, Dapkus L, Wood J, Adams R, Blomquist G, Sterchi L, Welch S, Gouine D, Racki S, Hodax J, Beauregard N, Pascual C, Franklin C, Bethin K, Majumdar I, Mastrandrea L, Quattrin T, Tabaczynski E, House A. Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technology & Therapeutics 2021, 23: 791-798. PMID: 34524023, DOI: 10.1089/dia.2021.0176.Peer-Reviewed Original ResearchConceptsHybrid closed-loop systemHybrid closed-loop insulin delivery systemMean percent timeRoutine clinical visitsPatient-reported outcomesType 1 diabetesClosed-loop insulin delivery systemUsual careClinical outcomesClinical visitsInsulin delivery systemsSleep interruptionClinical dataClinic dataType 1Glucose monitor dataPercent timeMonthsTarget rangePatientsContinuous glucose monitor dataAdequate trainingBaselineCurrent knowledgeOutcomesContinuous Ketone Monitoring Consensus Report 2021
Nguyen KT, Xu NY, Zhang JY, Shang T, Basu A, Bergenstal RM, Castorino K, Chen KY, Kerr D, Koliwad SK, Laffel LM, Mathioudakis N, Midyett LK, Miller JD, Nichols JH, Pasquel FJ, Prahalad P, Prausnitz MR, Seley JJ, Sherr JL, Spanakis EK, Umpierrez GE, Wallia A, Klonoff DC. Continuous Ketone Monitoring Consensus Report 2021. Journal Of Diabetes Science And Technology 2021, 16: 689-715. PMID: 34605694, PMCID: PMC9294575, DOI: 10.1177/19322968211042656.Peer-Reviewed Original ResearchConceptsDiabetic ketoacidosisMedical literaturePrevention of DKAAdvanced practice nursingAdult endocrinologyDiabetes Technology SocietyClinical trialsInsulin delivery systemsConsensus panelHuman trialsPractice nursingPediatric endocrinologyKetone monitoringPrivate practiceDiabetes technologyClinical chemistryKetone productionTrialsEndocrinologyDelivery systemReportConclusionKetoacidosisKetonuriaKetonemiaMulticenter 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 170-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 injections
2012
Effect of Pramlintide on Prandial Glycemic Excursions During Closed-Loop Control in Adolescents and Young Adults With Type 1 Diabetes
Weinzimer SA, Sherr JL, Cengiz E, Kim G, Ruiz JL, Carria L, Voskanyan G, Roy A, Tamborlane WV. Effect of Pramlintide on Prandial Glycemic Excursions During Closed-Loop Control in Adolescents and Young Adults With Type 1 Diabetes. Diabetes Care 2012, 35: 1994-1999. PMID: 22815298, PMCID: PMC3447854, DOI: 10.2337/dc12-0330.Peer-Reviewed Original ResearchConceptsGlycemic excursionsBG excursionsEffects of pramlintideBlood glucose excursionsAbsorption of insulinContent of mealsPreprandial injectionsInsulin levelsPostprandial glycemiaGlucose excursionsInsulin delivery systemsInsulin concentrationsGlucose riseManual bolusesInsulin feedbackPostprandial BGStudy daysPramlintideCL controlInsulin absorptionType 1Beneficial effectsSubcutaneous sitesTarget glucoseYoung adultsEffect of Insulin Feedback on Closed-Loop Glucose Control: A Crossover Study
Ruiz JL, Sherr JL, Cengiz E, Carria L, Roy A, Voskanyan G, Tamborlane WV, Weinzimer SA. Effect of Insulin Feedback on Closed-Loop Glucose Control: A Crossover Study. Journal Of Diabetes Science And Technology 2012, 6: 1123-1130. PMID: 23063039, PMCID: PMC3570847, DOI: 10.1177/193229681200600517.Peer-Reviewed Original ResearchConceptsBG excursionsPostprandial hypoglycemiaBG levelsMeal-related glucose excursionsInsulin deliveryLate postprandial hypoglycemiaTotal insulin deliveryOverall glycemic controlOccurrence of hypoglycemiaClosed-loop glucose controlMean BG levelClosed-loop insulin delivery systemAverage BG levelsBlood glucose responseSeparate admissionsGlycemic controlCrossover studyGlucose controlHypoglycemic eventsGlucose excursionsInsulin delivery systemsGlucose riseBG controlInsulin feedbackManual boluses