2024
Consensus Report on Glucagon-Like Peptide-1 Receptor Agonists as Adjunctive Treatment for Individuals With Type 1 Diabetes Using an Automated Insulin Delivery System.
Shah V, Peters A, Umpierrez G, Sherr J, Akturk H, Aleppo G, Bally L, Cengiz E, Cinar A, Dungan K, Fabris C, Jacobs P, Lal R, Mader J, Masharani U, Prahalad P, Schmidt S, Zijlstra E, Ho C, Ayers A, Tian T, Aaron R, Klonoff D. Consensus Report on Glucagon-Like Peptide-1 Receptor Agonists as Adjunctive Treatment for Individuals With Type 1 Diabetes Using an Automated Insulin Delivery System. Journal Of Diabetes Science And Technology 2024, 19322968241291512. PMID: 39517127, DOI: 10.1177/19322968241291512.Peer-Reviewed Original ResearchGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsGLP-1RA therapyGLP-1RAGLP-1RAsType 1 diabetesReceptor agonistsAdjunctive therapyAbsence of randomized controlled trialsIncreasing prevalence of obesityUS Food and Drug AdministrationRisk of severe hypoglycemiaEffective adjunctive therapyPrevalence of obesityTreatment of T1DFood and Drug AdministrationRandomized controlled trialsDiabetic ketoacidosisAdjunctive treatmentMetabolic outcomesSevere hypoglycemiaAutomated insulin deliveryConsensus reportDrug AdministrationTherapyGlycemic 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 systemsEpisodesSevere Hypoglycemia and Impaired Awareness of Hypoglycemia Persist in People With Type 1 Diabetes Despite Use of Diabetes Technology: Results From a Cross-sectional Survey
Sherr J, Laffel L, Liu J, Wolf W, Bispham J, Chapman K, Finan D, Titievsky L, Liu T, Hagan K, Gaglia J, Chandarana K, Bergenstal R, Pettus J. Severe Hypoglycemia and Impaired Awareness of Hypoglycemia Persist in People With Type 1 Diabetes Despite Use of Diabetes Technology: Results From a Cross-sectional Survey. Diabetes Care 2024, 47: 941-947. PMID: 38295397, PMCID: PMC11116910, DOI: 10.2337/dc23-1765.Peer-Reviewed Original ResearchImpaired awareness of hypoglycemiaSevere hypoglycemic eventsType 1 diabetesGlycemic targetsContinuous glucose monitoringInsulin delivery modalityDiabetes technologyImproved treatment strategiesAwareness of hypoglycemiaImpaired awarenessU.S. RESEARCH DESIGNAdvanced diabetes technologiesProportion of participantsCross-sectional surveySubgroup analysisSevere hypoglycemiaTreatment strategiesAutomated insulin deliveryImpact of continuous glucose monitoringGlycemic metricsHypoglycemic eventsObservational studyProportion of peopleResearch designInsulin delivery
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 rangeAdultsHbA1cChildrenEpisodesSafety 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 TBR
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 phase33-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 benefits100-LB: Glycemic Control Using Recommended Settings in Youth and Adults with Type 1 Diabetes (T1D) —Minimed 780G System with the Calibration-Free Guardian 4 Sensor Results
VIGERSKY R, BODE B, BRAZG R, BUCKINGHAM B, CARLSON A, KAISERMAN K, KIPNES M, LILJENQUIST D, PHILIS-TSIMIKAS A, PIHOKER C, POP-BUSUI R, REED J, SHERR J, SHULMAN D, SLOVER R, THRASHER J, CHEN X, LIU M, CORDERO T, VELLA M, RHINEHART A, SHIN J. 100-LB: Glycemic Control Using Recommended Settings in Youth and Adults with Type 1 Diabetes (T1D) —Minimed 780G System with the Calibration-Free Guardian 4 Sensor Results. Diabetes 2022, 71 DOI: 10.2337/db22-100-lb.Peer-Reviewed Original ResearchMannKind CorporationSpeakers bureauKidney diseaseNovo NordiskEli LillyAdvisory PanelNational InstituteHealth researchMonths of useEffectiveness endpointReata PharmaceuticalsGlycemic controlPivotal trialsSevere hypoglycemiaEffectiveness outcomesGlycemic metricsDiabetesBayer AGHealth groupsRoche DiagnosticsUnitedHealth GroupLexicon PharmaceuticalsMiniMedTarget rangeSanofi
2021
Multicenter 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 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
Effect 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
1424-P: Changes in Device Uptake and Glycemic Control among Pregnant Women with Type 1 Diabetes: Data from the T1D Exchange
LEVY C, FOSTER N, DUBOSE S, AGARWAL S, LYONS S, PETERS A, UWAIFO G, DIMEGLIO L, SHERR J, POLSKY S. 1424-P: Changes in Device Uptake and Glycemic Control among Pregnant Women with Type 1 Diabetes: Data from the T1D Exchange. Diabetes 2019, 68 DOI: 10.2337/db19-1424-p.Peer-Reviewed Original ResearchPregnant womenMannKind CorporationSanofi USKidney diseaseDiabetes FoundationPump useT1D Exchange Clinic RegistryEli LillyLexicon PharmaceuticalsBarbara Davis CenterInsulin pump useCohort of womenType 1 diabetesReal-world populationNational InstituteAdvisory PanelHelmsley Charitable TrustHealth researchPregnancy outcomesGlycemic controlSevere hypoglycemiaClinic registrySelf-reported useT1D ExchangeNovo Nordisk A/S
2012
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
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
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