2018
Eligibility for clinical trials is limited for youth with type 2 diabetes: Insights from the Pediatric Diabetes Consortium T2D Clinic Registry
Tamborlane WV, Chang P, Kollman C, Klingensmith GJ, Ruedy K, Gal RL, Van Name M, Bacha F, Willi S, Beck RW, Consortium F. Eligibility for clinical trials is limited for youth with type 2 diabetes: Insights from the Pediatric Diabetes Consortium T2D Clinic Registry. Pediatric Diabetes 2018, 19: 1379-1384. PMID: 30175440, DOI: 10.1111/pedi.12763.Peer-Reviewed Original ResearchConceptsType 2 diabetesT2D durationT2D patientsClinical trialsEligibility criteriaPlacebo-assigned subjectsPercentage of patientsCurrent clinical trialsRestrictive eligibility criteriaBaseline HbA1cHbA1c levelsClinical characteristicsClinic registryRegistry enrollmentInvestigational treatmentPatientsCurrent trialTrialsNew drugsMonthsHbA1cRatio of femaleDiabetesRegistryEnrollmentThe present and future treatment of pediatric type 2 diabetes
Van Name MA, Guandalini C, Steffen A, Patel A, Tamborlane W. The present and future treatment of pediatric type 2 diabetes. Expert Review Of Endocrinology & Metabolism 2018, 13: 207-212. PMID: 30063424, DOI: 10.1080/17446651.2018.1499467.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsType 2 diabetesPediatric type 2 diabetesStandard initial treatmentMetformin monotherapyPediatric T2DClinical outcomesInitial treatmentPediatric populationClinical trialsRapid progressionInjectable agentsFuture treatmentMetabolic controlT2DDiabetesNew drugsInsulinPhase 3DrugsRegulatory approvalT2D.TreatmentPatientsMetforminCurrent use
2016
Barriers to participation in industry‐sponsored clinical trials in pediatric type 2 diabetes
Farrell R, Bethin K, Klingensmith G, Tamborlane WV, Gubitosi‐Klug R. Barriers to participation in industry‐sponsored clinical trials in pediatric type 2 diabetes. Pediatric Diabetes 2016, 18: 574-578. PMID: 27807915, DOI: 10.1111/pedi.12465.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAttitude of Health PersonnelChildDiabetes Mellitus, Type 2Drug ApprovalDrug IndustryDrugs, InvestigationalEndocrinologyHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInternetNeeds AssessmentPatient SelectionPediatricsRandomized Controlled Trials as TopicResearch PersonnelResearch Support as TopicSocieties, ScientificSurveys and QuestionnairesUnited StatesUnited States Food and Drug AdministrationWorkforceConceptsPediatric Endocrine SocietyType 2 diabetesClinical trialsPediatric endocrinologistsIndustry-sponsored clinical trialsPatients age 18 yearsPediatric type 2 diabetesCurrent glycemic controlNew T2D casesAdditional treatment optionsAge 18 yearsBaseline demographicsT2D patientsGlycemic controlMedication useMultiple medicationsPediatric patientsResearch nursesPediatric populationTreatment optionsEndocrine SocietyT2D casesDrug AdministrationVisit scheduleAnonymous online survey
2015
Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial
Libman IM, Miller KM, DiMeglio LA, Bethin KE, Katz ML, Shah A, Simmons JH, Haller MJ, Raman S, Tamborlane WV, Coffey JK, Saenz AM, Beck RW, Nadeau KJ. Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 2015, 314: 2241-2250. PMID: 26624824, DOI: 10.1001/jama.2015.16174.Peer-Reviewed Original ResearchConceptsType 1 diabetesBody mass indexGastrointestinal adverse eventsEffect of metforminTotal daily insulinGlycemic controlPlacebo groupOverweight adolescentsMetformin groupBaseline HbA1cAdverse eventsDaily insulinClinical trialsMultiple secondary end pointsOverweight/obese adolescentsSafety of metforminSecondary end pointsUse of metforminAddition of metforminBMI z-scoreMeasures of adipositySecondary outcomesBlood pressureInsulin dosePrimary outcome
2013
Extended 6-Month Follow-Up of 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
Tansey M, Weinzimer S, Beck R, Ruedy K, Cheng P, Tamborlane W, Kollman C, Mauras N, Fox L, Coffey J, White NH, Group F. Extended 6-Month Follow-Up of 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 2013, 36: e63-e63. PMID: 23613604, PMCID: PMC3631880, DOI: 10.2337/dc12-2021.Peer-Reviewed Original Research
2012
A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes
Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan D, Tollefsen S, Wilfley D, Kaufman F. A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes. New England Journal Of Medicine 2012, 366: 2247-2256. PMID: 22540912, PMCID: PMC3478667, DOI: 10.1056/nejmoa1109333.Peer-Reviewed Original ResearchConceptsType 2 diabetesDurable glycemic controlGlycated hemoglobin levelsGlycemic controlLifestyle interventionPrimary outcomeHemoglobin levelsRecent-onset type 2 diabetesIntensive lifestyle interventionSerious adverse eventsLifestyle intervention programAddition of rosiglitazoneNon-Hispanic black participantsHalf of childrenYears of ageAdverse eventsPatients 10Prespecified analysisMetabolic decompensationRate of failureTreatment regimensClinical trialsMetforminType 2RosiglitazoneA 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
2008
Effect of a Successful Intensive Lifestyle Program on Insulin Sensitivity and Glucose Tolerance in Obese Youth
Shaw M, Savoye M, Cali A, Dziura J, Tamborlane WV, Caprio S. Effect of a Successful Intensive Lifestyle Program on Insulin Sensitivity and Glucose Tolerance in Obese Youth. Diabetes Care 2008, 32: 45-47. PMID: 18840769, PMCID: PMC2606827, DOI: 10.2337/dc08-0808.Peer-Reviewed Original ResearchConceptsIntensive lifestyle programLifestyle programInsulin sensitivityObese youthBody fatGlucose metabolismLarge randomized clinical trialsOral glucose tolerance testGlucose tolerance testRandomized clinical trialsGlucose toleranceObese childrenControl subjectsTolerance testClinical trialsBody compositionBody weightSubject changesGreater decreaseSubjectsFatMetabolismBMIResearch designBright bodiesContinuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes
Tamborlane W, Beck R, Bode B, Buckingham B, Chase H, Clemons R, Fiallo-Scharer R, Fox L, Gilliam L, Hirsch I, Huang E, Kollman C, Kowalski A, Laffel L, Lawrence J, Lee J, Mauras N, O'Grady M, Ruedy K, Tansey M, Tsalikian E, Weinzimer S, Wilson D, Wolpert H, Wysocki T, Xing D. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. New England Journal Of Medicine 2008, 359: 1464-1476. PMID: 18779236, DOI: 10.1056/nejmoa0805017.Peer-Reviewed Original ResearchConceptsYears of ageContinuous glucose monitoringContinuous monitoring groupPatients 25 yearsGlycated hemoglobin levelsType 1 diabetesHemoglobin levelsGlucose monitoringStudy groupControl groupType 1 diabetes mellitusMulticenter clinical trialBetween-group differencesHemoglobin outcomesYounger patientsDiabetes mellitusGlycemic controlIntensive therapyPrimary outcomeSevere hypoglycemiaClinical trialsIntensive treatmentAge groupsBlood glucose metersType 1
2005
Comparison of fingerstick hemoglobin A1c levels assayed by DCA 2000 with the DCCT/EDIC central laboratory assay: results of a Diabetes Research in Children Network (DirecNet) Study
Tamborlane WV, Kollman C, Steffes MW, Ruedy KJ, Dongyuan X, Beck RW, Chase P, Fox LA, Wilson DM, Tsalikian E. Comparison of fingerstick hemoglobin A1c levels assayed by DCA 2000 with the DCCT/EDIC central laboratory assay: results of a Diabetes Research in Children Network (DirecNet) Study. Pediatric Diabetes 2005, 6: 13-16. PMID: 15787896, DOI: 10.1111/j.1399-543x.2005.00088.x.Peer-Reviewed Original ResearchConceptsDCA 2000Central laboratory valuesHbA1c valuesClinical centersLaboratory valuesComplications Trial/EpidemiologyType 1 diabetes mellitusMean differenceDiabetes researchBaseline HbA1c levelsHemoglobin A1c levelsCentral laboratoryOutpatient clinical trialAdditional blood samplesCentral laboratory methodHbA1c levelsA1c levelsDiabetes mellitusDiabetes practiceDiabetes controlDiabetes InterventionsClinical trialsSame visitBlood samplesReference standard
2004
Continuous glucose monitoring in type 1 diabetes
Weinzimer SA, Tamborlane WV, Chase HP, Garg SK. Continuous glucose monitoring in type 1 diabetes. Current Diabetes Reports 2004, 4: 95-100. PMID: 15035968, DOI: 10.1007/s11892-004-0063-z.Peer-Reviewed Original Research