2024
Real-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 rangePostprandial Glucose Variability Following Typical Meals in Youth Living with Type 1 Diabetes
Patton S, Bergford S, Sherr J, Gal R, Calhoun P, Clements M, Riddell M, Martin C. Postprandial Glucose Variability Following Typical Meals in Youth Living with Type 1 Diabetes. Nutrients 2024, 16: 162. PMID: 38201991, PMCID: PMC10781146, DOI: 10.3390/nu16010162.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentBlood GlucoseBlood Glucose Self-MonitoringChildDiabetes Mellitus, Type 1FemaleGlucoseHumansInsulinMaleMealsConceptsGlycemic variabilityGlucose variabilityType 1Continuous glucose monitoringPediatric studiesCarbohydrate intakeDay observation periodMacronutrient intakeDietary guidelinesPhysical activityExercise intensityT1DGlucose monitoringObservation periodTypical mealMeal contentMealIntakeCoefficient of variationAssociationMacronutrient contentMore carbohydratesCliniciansLarge 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 rangeAdultsHbA1cChildrenEpisodesThe Acute Effects of Real-World Physical Activity on Glycemia in Adolescents With Type 1 Diabetes: The Type 1 Diabetes Exercise Initiative Pediatric (T1DEXIP) Study.
Riddell M, Gal R, Bergford S, Patton S, Clements M, Calhoun P, Beaulieu L, Sherr J. The Acute Effects of Real-World Physical Activity on Glycemia in Adolescents With Type 1 Diabetes: The Type 1 Diabetes Exercise Initiative Pediatric (T1DEXIP) Study. Diabetes Care 2023, 47: 132-139. PMID: 37922335, DOI: 10.2337/dc23-1548.Peer-Reviewed Original ResearchConceptsReal-world physical activityPhysical activityType 1Pediatric studiesHeart rateLower baseline HbA1c levelsReal-world observational studySelf-reported physical activityBaseline HbA1c levelsShorter disease durationPeak heart rateType 1 diabetesSelf-management strategiesDisease durationHbA1c levelsMedian durationLess hypoglycemiaLower BMIAcute effectsContinuous glucose monitoring dataObservational studyFood intakeEvent-level factorsInsulin dosingActive adolescentsSafety 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 TBROGTT Metrics Surpass Continuous Glucose Monitoring Data for T1D Prediction in Multiple-Autoantibody–Positive Individuals
Ylescupidez A, Speake C, Pietropaolo S, Wilson D, Steck A, Sherr J, Gaglia J, Bender C, Lord S, Greenbaum C. OGTT Metrics Surpass Continuous Glucose Monitoring Data for T1D Prediction in Multiple-Autoantibody–Positive Individuals. The Journal Of Clinical Endocrinology & Metabolism 2023, 109: 57-67. PMID: 37572381, PMCID: PMC10735531, DOI: 10.1210/clinem/dgad472.Peer-Reviewed Original ResearchMeSH KeywordsAutoantibodiesBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Glucose Tolerance TestHumansConceptsContinuous glucose monitoringClinical trialsPositive individualsOral glucose tolerance testPrediction of T1DGlucose tolerance testType 1 diabetesCGM dataTrialNet PathwayMultiple autoantibodiesT1D diagnosisTolerance testAncillary studiesContinuous glucose monitoring dataMultivariable modelCGM metricsInsufficient evidenceAcademic centersGlucose monitoring dataHigh discriminative abilityT1D predictionGlucose monitoringCGM measuresCharacteristic curveOGTTGlycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor
Cordero T, Dai Z, Arrieta A, Niu F, Vella M, Shin J, Rhinehart A, McVean J, Lee S, Slover R, Forlenza G, Shulman D, Pop-Busui R, Thrasher J, Kipnes M, Christiansen M, Buckingham B, Pihoker C, Sherr J, Kaiserman K, Vigersky R, Group F. Glycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor. Diabetes Technology & Therapeutics 2023, 25: 652-658. PMID: 37252734, PMCID: PMC10460682, DOI: 10.1089/dia.2023.0123.Peer-Reviewed Original ResearchImpact of school‐supervised ultra‐long‐acting basal insulin injections on ketosis in youth with T1D and elevated haemoglobin A1c: A pilot study
Nally L, Sherr J, Tichy E, Weyman K, Urban A, Shabanova V, McCollum S, Steffen A, Tamborlane W, Van Name M. Impact of school‐supervised ultra‐long‐acting basal insulin injections on ketosis in youth with T1D and elevated haemoglobin A1c: A pilot study. Diabetic Medicine 2023, 40: e15123. PMID: 37078999, PMCID: PMC10524154, DOI: 10.1111/dme.15123.Peer-Reviewed Original ResearchConceptsBasal insulin injectionsDiabetic ketoacidosisPercent of participantsBlood β-hydroxybutyrateInsulin injectionsBasal insulin dosesBasal insulin typeType 1 diabetesManagement of youthDegludec groupSignificant ketosisAcute complicationsBasal insulinInsulin dosesRisk of ketosisInjected insulinHigher hemoglobinInsulin administrationElevated hemoglobinInsulin typeKetone levelsHigh riskSchool nursesDegludecLarger sample sizeCGM Metrics Identify Dysglycemic States in Participants From the TrialNet Pathway to Prevention Study.
Wilson D, Pietropaolo S, Acevedo-Calado M, Huang S, Anyaiwe D, Scheinker D, Steck A, Vasudevan M, McKay S, Sherr J, Herold K, Dunne J, Greenbaum C, Lord S, Haller M, Schatz D, Atkinson M, Nelson P, Pietropaolo M. CGM Metrics Identify Dysglycemic States in Participants From the TrialNet Pathway to Prevention Study. Diabetes Care 2023, 46: 526-534. PMID: 36730530, PMCID: PMC10020029, DOI: 10.2337/dc22-1297.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAutoantibodiesBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleGlucoseHumansMaleConceptsOral glucose tolerance testNormal oral glucose tolerance testType 1 diabetesDiabetes-related autoantibodiesGlucose levelsCGM metricsTrialNet PathwayPrevention StudyAbnormal oral glucose tolerance testGlucose valuesGlucose tolerance testContinuous glucose monitoring parametersStage 2 participantsRelatives of individualsCGMS assessmentDysglycemic statesTolerance testIdentification of individualsDiabetesNegative testAutoantibodiesProgressionBaseline dataIndividualsParticipantsDiabetes 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 ResearchMeSH KeywordsBlood GlucoseBlood Glucose Self-MonitoringDiabetes MellitusHumansInsulinTechnologyUnited StatesConceptsAmerican 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 dataCareReportGroupWhen insulin isn’t enough: targeting glucagon in type 1 diabetes
Van Name M, Sherr J. When insulin isn’t enough: targeting glucagon in type 1 diabetes. Nature Medicine 2022, 28: 2007-2008. PMID: 36192555, DOI: 10.1038/s41591-022-02019-3.Commentaries, Editorials and LettersConsensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice
Phillip M, Nimri R, Bergenstal RM, Barnard-Kelly K, Danne T, Hovorka R, Kovatchev BP, Messer LH, Parkin CG, Ambler-Osborn L, Amiel SA, Bally L, Beck RW, Biester S, Biester T, Blanchette JE, Bosi E, Boughton CK, Breton MD, Brown SA, Buckingham BA, Cai A, Carlson AL, Castle JR, Choudhary P, Close KL, Cobelli C, Criego AB, Davis E, de Beaufort C, de Bock MI, DeSalvo DJ, DeVries JH, Dovc K, Doyle FJ, Ekhlaspour L, Shvalb NF, Forlenza GP, Gallen G, Garg SK, Gershenoff DC, Gonder-Frederick LA, Haidar A, Hartnell S, Heinemann L, Heller S, Hirsch IB, Hood KK, Isaacs D, Klonoff DC, Kordonouri O, Kowalski A, Laffel L, Lawton J, Lal RA, Leelarathna L, Maahs DM, Murphy HR, Nørgaard K, O’Neal D, Oser S, Oser T, Renard E, Riddell MC, Rodbard D, Russell SJ, Schatz DA, Shah VN, Sherr JL, Simonson GD, Wadwa RP, Ward C, Weinzimer SA, Wilmot EG, Battelino T. Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice. Endocrine Reviews 2022, 44: 254-280. PMID: 36066457, PMCID: PMC9985411, DOI: 10.1210/endrev/bnac022.Peer-Reviewed Original ResearchMeSH KeywordsBlood GlucoseBlood Glucose Self-MonitoringConsensusDiabetes Mellitus, Type 1HumansHypoglycemic AgentsInsulinConceptsInsulin delivery technologiesGlycemic goalsNear-normal glucose levelsLong-term complicationsReal-world studyHypoglycemia riskDiabetes QualityConsensus recommendationsGlucose levelsGlobal prevalenceDiabetes managementEligibility criteriaClinical practiceDelivery technologiesHealthcare providersClinical settingDiabetesInsurance coverageSignificant proportionCliniciansAid successPWDPayersComplicationsTremendous advancesSafety 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 improvementDistressMulticenterPharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes
Buckingham B, Sherr J, Prestrelski S, Conoscenti V. Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes. Pediatric Diabetes 2022, 23: 754-762. PMID: 35562186, DOI: 10.1111/pedi.13360.Peer-Reviewed Original ResearchConceptsPlasma glucose concentrationType 1 diabetesAged 2 to <Common adverse eventsAge-appropriate dosesGlucose concentrationGlucagon formulationsManagement of hypoglycemiaPrimary endpointAdverse eventsMedical complicationsPK parametersPharmacodynamicsPharmacokineticsReady-to-useT1DGlucagonHypoglycemiaAge cohortsCohortAutoinjectorPlasmaBaselineAgeYearsDiabetes Technology Meeting 2021
Xu NY, Nguyen KT, DuBord AY, Pickup J, Sherr JL, Teymourian H, Cengiz E, Ginsberg BH, Cobelli C, Ahn D, Bellazzi R, Bequette BW, Pickett L, Parks L, Spanakis EK, Masharani U, Akturk HK, Melish JS, Kim S, Kang GE, Klonoff DC. Diabetes Technology Meeting 2021. Journal Of Diabetes Science And Technology 2022, 16: 1016-1056. PMID: 35499170, PMCID: PMC9264449, DOI: 10.1177/19322968221090279.Peer-Reviewed Original Research
2021
Continuous glucose monitoring use and glucose variability in very young children with type 1 diabetes (VibRate): A multinational prospective observational real‐world cohort study
Dovc K, Van Name M, Bizjan B, Rusak E, Piona C, Yesiltepe‐Mutlu G, Mentink R, Frontino G, Macedoni M, Ferreira SH, Serra‐Caetano J, Galhardo J, Pelicand J, Silvestri F, Sherr J, Chobot A, Biester T, Group F. Continuous glucose monitoring use and glucose variability in very young children with type 1 diabetes (VibRate): A multinational prospective observational real‐world cohort study. Diabetes Obesity And Metabolism 2021, 24: 564-569. PMID: 34820985, PMCID: PMC9306649, DOI: 10.1111/dom.14607.Peer-Reviewed Original ResearchSafety 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 eventsA1C