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 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 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 TBRGlycemic 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 size
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 phase
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 ResearchHemoglobin A1c Patterns of Youth With Type 1 Diabetes 10 Years Post Diagnosis From 3 Continents
Sherr JL, Schwandt A, Phelan H, Clements MA, Holl RW, Benitez-Aguirre PZ, Miller KM, Woelfle J, Dover T, Maahs DM, Fröhlich-Reiterer E, Craig ME. Hemoglobin A1c Patterns of Youth With Type 1 Diabetes 10 Years Post Diagnosis From 3 Continents. Pediatrics 2021, 148: e2020048942. PMID: 34315809, PMCID: PMC8785705, DOI: 10.1542/peds.2020-048942.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentChildChild, PreschoolDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansInternationalityMaleRegistriesTime FactorsMulticenter 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
2020
A Pilot Study of Youth With Type 1 Diabetes Initiating Use of a Hybrid Closed-Loop System While Receiving a Behavioral Economics Intervention
Nally LM, Wagner J, Sherr J, Tichy E, Weyman K, Ginley MK, Zajac K, Desousa M, Shabanova V, Petry NM, Tamborlane WV, Van Name M. A Pilot Study of Youth With Type 1 Diabetes Initiating Use of a Hybrid Closed-Loop System While Receiving a Behavioral Economics Intervention. Endocrine Practice 2020, 27: 545-551. PMID: 34120699, PMCID: PMC8206518, DOI: 10.1016/j.eprac.2020.11.017.Peer-Reviewed Original ResearchIncident diabetes complications among women with type 1 diabetes based on parity
Polsky S, Foster NC, DuBose SN, Agarwal S, Lyons S, Peters AL, Uwaifo GI, DiMeglio LA, Sherr JL, Levy CJ. Incident diabetes complications among women with type 1 diabetes based on parity. The Journal Of Maternal-Fetal & Neonatal Medicine 2020, 35: 4629-4634. PMID: 33280471, DOI: 10.1080/14767058.2020.1858278.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultDiabetes ComplicationsDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansHypertensionParityPregnancyRisk FactorsYoung AdultConceptsType 1 diabetesParous womenNulliparous womenDiabetes complicationsRisk factorsHigher body mass indexAdverse lipid profileTriglyceride/HDLOverweight/obesityBody mass indexAdvanced nephropathyMass indexT1D ExchangeFirst pregnancyPregnant womenChildbirth QuestionnaireLipid profileCardiovascular diseaseComplicationsWomenHypertensionYear 5Further studiesSignificant differencesDiabetesChanges 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 evaluationEffect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes
Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes. JAMA 2020, 323: 2388-2396. PMID: 32543683, PMCID: PMC7298603, DOI: 10.1001/jama.2020.6940.Peer-Reviewed Original ResearchConceptsType 1 diabetesContinuous glucose monitoringGlycemic controlPatient-reported outcomesGlucose monitoringYoung adultsSecondary outcomesCGM groupHbA1c outcomesEffects of CGMType 1 diabetes exhibitBGM groupRandomized clinical trialsWorse glycemic controlBlood glucose monitoringDiabetic ketoacidosisMean HbA1cUsual careEndocrinology practiceAdverse eventsMonth 6Primary outcomeSevere hypoglycemiaClinical trialsCGM metrics
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 routineAdults
2012
Teplizumab treatment may improve C-peptide responses in participants with type 1 diabetes after the new-onset period: a randomised controlled trial
Herold KC, Gitelman SE, Willi SM, Gottlieb PA, Waldron-Lynch F, Devine L, Sherr J, Rosenthal SM, Adi S, Jalaludin MY, Michels AW, Dziura J, Bluestone JA. Teplizumab treatment may improve C-peptide responses in participants with type 1 diabetes after the new-onset period: a randomised controlled trial. Diabetologia 2012, 56: 391-400. PMID: 23086558, PMCID: PMC3537871, DOI: 10.1007/s00125-012-2753-4.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAntibodies, Monoclonal, HumanizedC-PeptideDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansInsulinMaleConceptsC-peptide responseType 1 diabetesImmune therapyHigh C-peptide responseCentral randomisation centreChronic autoimmune processPlacebo-treated participantsPlacebo-controlled trialPrimary outcome analysisCharacteristics of patientsC-peptide levelsSubgroup of patientsC-peptide productionTeplizumab groupClinical respondersAutoimmune processPrimary outcomeExogenous insulinMixed mealSubgroup analysisResultsThirty-fourInsulin secretionTreatment benefitBaseline imbalancesTeplizumabAchievement of Target A1C Levels With Negligible Hypoglycemia and Low Glucose Variability in Youth With Short-Term Type 1 Diabetes and Residual β-Cell Function
Sherr J, Tamborlane WV, Xing D, Tsalikian E, Mauras N, Buckingham B, White NH, Arbelaez AM, Beck RW, Kollman C, Ruedy K, . Achievement of Target A1C Levels With Negligible Hypoglycemia and Low Glucose Variability in Youth With Short-Term Type 1 Diabetes and Residual β-Cell Function. Diabetes Care 2012, 35: 817-820. PMID: 22323414, PMCID: PMC3308298, DOI: 10.2337/dc11-2190.Peer-Reviewed Original ResearchConceptsResidual β-cell functionΒ-cell functionSensor glucose levelsLower glucose variabilityType 1 diabetesGlucose levelsContinuous glucose monitoringT1D participantsGlucose variabilityMean sensor glucose levelPeak C-peptide levelsMixed meal tolerance testTarget A1C levelsC-peptide levelsLong-term T1DShort-term groupNondiabetic groupT1D groupA1c levelsT1D patientsLess hyperglycemiaNondiabetic individualsTolerance testInsulin treatmentHypoglycemiaA Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children Aged 4 to <10 Years
Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C, . A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children Aged 4 to <10 Years. Diabetes Care 2012, 35: 204-210. PMID: 22210571, PMCID: PMC3263860, DOI: 10.2337/dc11-1746.Peer-Reviewed Original ResearchConceptsType 1 diabetesContinuous glucose monitoringGlycemic controlPrimary outcomeParental satisfactionReal-time continuous glucose monitoringGlucose monitoringSevere hypoglycemia ratesDays/weekGlucose dataUsual careHypoglycemia ratesSevere hypoglycemiaCGM groupClinical trialsChildren Aged 4Control groupDiabetesHypoglycemiaDay managementAged 4WeeksParental fearYoung childrenChildren
2011
Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes
Tsalikian E, Fox L, Weinzimer S, Buckingham B, White NH, Beck R, Kollman C, Xing D, Ruedy K, Group D. Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes. Pediatric Diabetes 2011, 13: 301-307. PMID: 22151826, PMCID: PMC3665108, DOI: 10.1111/j.1399-5448.2011.00837.x.Peer-Reviewed Original ResearchConceptsType 1 diabetesParental satisfactionMultiple daily injectionsContinuous glucose monitoring useYr of ageYoung childrenContinuous glucose monitoringMean HbA1cMean hemoglobinGlycemic controlMonth 6Daily injectionsMean ageSkin reactionsBiochemical hypoglycemiaCGM useGlucose valuesGlucose readingsInsulin pumpHyperglycemic excursionsHyperglycemic rangeGlucose monitoringMonthsWkDiabetes
2010
Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes
Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. New England Journal Of Medicine 2010, 363: 311-320. PMID: 20587585, DOI: 10.1056/nejmoa1002853.Peer-Reviewed Original ResearchConceptsInjection therapy groupPump-therapy groupSensor-augmented pump therapyGlycated hemoglobin levelsHemoglobin levelsType 1 diabetesPump therapyBaseline glycated hemoglobin levelMultiple daily insulin injectionsType 1 diabetes mellitusGlycated haemoglobin targetPrimary end pointProportion of patientsDaily insulin injectionsSignificant weight gainRecombinant insulin analogueHemoglobin targetsInjection therapyDiabetes mellitusSevere hypoglycemiaInsulin injectionsClinical teamInsulin analoguesEnd pointTherapy