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 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 phasePharmacodynamics, 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 cohortsCohortAutoinjectorPlasmaBaselineAgeYears
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
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
2013
Lack of Association Between Residual Insulin Production and Glucagon Response to Hypoglycemia in Youth With Short Duration of Type 1 Diabetes
Sherr J, Xing D, Ruedy KJ, Beck RW, Kollman C, Buckingham B, White NH, Fox L, Tsalikian E, Weinzimer S, Arbelaez AM, Tamborlane WV, Network F. Lack of Association Between Residual Insulin Production and Glucagon Response to Hypoglycemia in Youth With Short Duration of Type 1 Diabetes. Diabetes Care 2013, 36: 1470-1476. PMID: 23288858, PMCID: PMC3661789, DOI: 10.2337/dc12-1697.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentChildDiabetes Mellitus, Type 1FemaleGlucagonHumansHypoglycemiaInsulinMaleYoung AdultConceptsMixed meal tolerance testΒ-cell functionResidual β-cell functionC-peptide levelsGlucagon responseT1D subjectsHypoglycemic clampPlasma glucagonPg/Endogenous β-cell functionPlasma C-peptide levelsAbsent glucagon responsesNondiabetic young adultsResidual insulin productionC-peptide responseNondiabetic control subjectsType 1 diabetesLack of associationT1D durationIncremental increaseControl subjectsTolerance testHypoglycemiaInsulin productionType 1
2012
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
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 treatmentHypoglycemia
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