2022
Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study
Tamborlane WV, Laffel LM, Shehadeh N, Isganaitis E, Van Name M, Ratnayake J, Karlsson C, Norjavaara E. Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. The Lancet Diabetes & Endocrinology 2022, 10: 341-350. PMID: 35378069, PMCID: PMC10851108, DOI: 10.1016/s2213-8587(22)00052-3.Peer-Reviewed Original ResearchConceptsType 2 diabetesPlacebo-assigned participantsPrespecified sensitivity analysisSafety of dapagliflozinPhase 3 studyBetween-group differencesAdverse eventsPrimary outcomeProtocol populationTreat analysisYoung adultsWeek double-blind periodRandomised phase 3 studyDouble-blind periodSerious adverse eventsNew safety signalsOral dapagliflozinDiabetic ketoacidosisSevere hypoglycaemiaMean ageTreatment optionsCare treatmentParallel groupSafety signalsStudy personnelLong-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study
Van Name MA, Kanapka LG, DiMeglio LA, Miller KM, Albanese-O’Neill A, Commissariat P, Corathers SD, Harrington KR, Hilliard ME, Anderson BJ, Kelley JC, Laffel LM, MacLeish SA, Nathan BM, Tamborlane WV, Wadwa RP, Willi SM, Williams KM, Wintergerst KA, Woerner S, Wong JC, DeSalvo DJ. Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study. Journal Of Diabetes Science And Technology 2022, 17: 976-987. PMID: 35343269, PMCID: PMC10348002, DOI: 10.1177/19322968221084667.Peer-Reviewed Original ResearchConceptsFamily behavioral interventionsContinuous glucose monitoringBlood glucose monitoringCGM useYoung childrenGlucose monitoringOne-year resultsType 1 diabetesContinuous glucose monitor useHemoglobin A1cCGM groupGlycemic outcomesType 1Behavioral interventionsExtension phaseBGM groupMonitor useOne-year studyCGM technologyDiabetes technologyGlycemiaHypoglycemiaChildrenBehavioural supportGroup
2020
Alcohol Use and Clinical Outcomes in Adults in the Type 1 Diabetes Exchange
Alessi SM, Foster NC, Rash CJ, Van Name MA, Tamborlane WV, Cengiz E, Polsky S, Wagner J. Alcohol Use and Clinical Outcomes in Adults in the Type 1 Diabetes Exchange. Canadian Journal Of Diabetes 2020, 44: 501-506. PMID: 32792103, DOI: 10.1016/j.jcjd.2020.06.005.Peer-Reviewed Original ResearchConceptsBody mass indexSevere hypoglycemiaFormer drinkersLower oddsAlcohol consumptionNonbinge drinkersType 1Current binge drinkersPresence of neuropathyDiabetes-related distressDiabetes-related outcomesType 1 diabetesCross-sectional studyYears of ageNon-Hispanic whitesDiabetic ketoacidosisRecent severe hypoglycemiaMedical chartsClinical outcomesMass indexProspective studyDiabetes distressBlood glucoseBinge drinkersDrinking statusEfficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care 2020, 43: 1512-1519. PMID: 32430458, PMCID: PMC7305011, DOI: 10.2337/dc19-1926.Peer-Reviewed Original Research
2019
Greater parental comfort with lower glucose targets in young children with Type 1 diabetes using continuous glucose monitoring
Van Name MA, Miller KM, Commissariat PV, Whitehouse AL, Harrington KR, Anderson BJ, Mantravadi MG, Levy W, DeSalvo DJ, Tamborlane WV, Hilliard ME, Laffel LM, DiMeglio LA. Greater parental comfort with lower glucose targets in young children with Type 1 diabetes using continuous glucose monitoring. Diabetic Medicine 2019, 36: 1508-1510. PMID: 31295359, PMCID: PMC7027357, DOI: 10.1111/dme.14074.Peer-Reviewed Original ResearchBenefits and Barriers of Continuous Glucose Monitoring in Young Children with Type 1 Diabetes
Hilliard ME, Levy W, Anderson BJ, Whitehouse AL, Commissariat PV, Harrington KR, Laffel LM, Miller KM, Van Name M, Tamborlane WV, DeSalvo DJ, DiMeglio LA. Benefits and Barriers of Continuous Glucose Monitoring in Young Children with Type 1 Diabetes. Diabetes Technology & Therapeutics 2019, 21: 493-498. PMID: 31287721, PMCID: PMC6708264, DOI: 10.1089/dia.2019.0142.Peer-Reviewed Original ResearchConceptsContinuous glucose monitoringCGM useDiabetes managementDiabetes careBenefits of CGMYoung childrenGlucose monitoringMean child ageChildren's diabetes careType 1 diabetes managementPainful insertionT1D durationParents of childrenGlucose excursionsImproved sleepClinical strategiesSemistructured qualitative interviewsType 1Parental comfortChild's ageChildrenBehavioural supportMultiple barriersParents' experiencesCaregiversContinuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study
Shah VN, DuBose SN, Li Z, Beck RW, Peters AL, Weinstock RS, Kruger D, Tansey M, Sparling D, Woerner S, Vendrame F, Bergenstal R, Tamborlane WV, Watson SE, Sherr J. Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. The Journal Of Clinical Endocrinology & Metabolism 2019, 104: 4356-4364. PMID: 31127824, PMCID: PMC7296129, DOI: 10.1210/jc.2018-02763.Peer-Reviewed Original ResearchConceptsContinuous glucose monitoringMedian timeAge groupsProspective studyNondiabetic individualsGlucose levelsAverage glucoseNonobese body mass indexT1D Exchange Clinic NetworkContinuous glucose monitoring (CGM) profilesInsulin-requiring patientsMulticenter prospective studyBody mass indexDifferent age groupsNondiabetic childrenNondiabetic populationGlycemic profileMass indexNondiabetic participantsGlycemic variabilityMean glucoseClinic networkCGM metricsGlycemic metricsGlucose monitoringImpact of Switching Youth With Diabetes to Insulin Degludec in Clinical Practice
Elahi S, Patel AD, Guandalini C, Steffen A, Sherr J, Tamborlane WV, Van Name MA. Impact of Switching Youth With Diabetes to Insulin Degludec in Clinical Practice. Endocrine Practice 2019, 25: 226-229. PMID: 30913005, DOI: 10.4158/ep-2018-0417.Peer-Reviewed Original ResearchConceptsType 1 diabetesInsulin degludecDiabetic ketoacidosisGlycemic controlCurrent regimenPatient's current regimenRetrospective chart reviewMonths of treatmentBeta-cell functionType 2 diabetesDiabetes-PatientenUltralong durationChart reviewGlycemic targetsBasal insulinHemoglobin A1cGlycemic outcomesMissed dosesOutcome differencesIDegClinical practiceDiabetes struggleDiabetesType 2Degludec
2017
International Consensus on Use of Continuous Glucose Monitoring
Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Nørgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care 2017, 40: 1631-1640. PMID: 29162583, PMCID: PMC6467165, DOI: 10.2337/dc17-1600.Peer-Reviewed Original ResearchContinuous Glucose Monitoring in Very Preterm Infants: A Randomized Controlled Trial
Galderisi A, Facchinetti A, Steil GM, Ortiz-Rubio P, Cavallin F, Tamborlane WV, Baraldi E, Cobelli C, Trevisanuto D. Continuous Glucose Monitoring in Very Preterm Infants: A Randomized Controlled Trial. Pediatrics 2017, 140: e20171162. PMID: 28916591, DOI: 10.1542/peds.2017-1162.Peer-Reviewed Original ResearchConceptsVery preterm infantsGlucose infusion rateContinuous glucose monitoringPreterm infantsCGM groupPercentage of timeEuglycemic rangeSevere hyperglycemiaSevere hypoglycemiaGlycemic variabilityGlucose monitoringCare blood glucose monitoringUse of CGMPoor neurologic outcomeImpaired glucose controlBlood glucose monitoringBlood glucose determinationNeurologic outcomeSecondary outcomesInsulin titrationPrimary outcomeWeeks' gestationControlled TrialsGlucose controlBirth weightPostprandial Dosing of Bolus Insulin in Patients with type 1 Diabetes: a Cross-sectional Study Using Data From the T1d Exchange Registry
Peters A, Van Name MA, Thorsted B, Piltoft JS, Tamborlane WV. Postprandial Dosing of Bolus Insulin in Patients with type 1 Diabetes: a Cross-sectional Study Using Data From the T1d Exchange Registry. Endocrine Practice 2017, 23: 1201-1209. PMID: 28704103, DOI: 10.4158/ep171813.or.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overBlood GlucoseBlood Glucose Self-MonitoringChildChild, PreschoolCross-Sectional StudiesDiabetes Mellitus, Type 1Diabetic KetoacidosisDrug Dosage CalculationsFemaleHumansHypoglycemiaInfantInsulinInsulin Infusion SystemsMaleMiddle AgedPostprandial PeriodRegistriesYoung AdultConceptsRapid-acting insulin analoguesLarger insulin doseT1D Exchange RegistryType 1 diabetesCross-sectional studyDiabetic ketoacidosisInsulin doseGreater prevalenceCurrent rapid-acting insulin analoguesInsulin analoguesSelf-monitoring blood glucosePercent of patientsCharacteristics of patientsPoor glycemic controlExclusion of patientsBody mass indexContinuous glucose monitoringPostprandial dosingGlycemic controlSevere hypoglycemiaBolus insulinMass indexEnrollment questionnaireBlood glucoseGlucose levelsThe Risk of Severe Hypoglycemia in Type 1 Diabetes Over 30 Years of Follow-up in the DCCT/EDIC Study
Gubitosi-Klug RA, Braffett BH, White NH, Sherwin RS, Service FJ, Lachin JM, Tamborlane WV, Group T. The Risk of Severe Hypoglycemia in Type 1 Diabetes Over 30 Years of Follow-up in the DCCT/EDIC Study. Diabetes Care 2017, 40: dc162723. PMID: 28550194, PMCID: PMC5521975, DOI: 10.2337/dc16-2723.Peer-Reviewed Original ResearchConceptsSevere hypoglycemiaTreatment groupsMean HbADiabetes therapyDCCT/EDIC cohortDCCT/EDIC studyIntensive diabetes therapyIntensive treatment groupSevere hypoglycemia ratesConventional treatment groupDuration of diabetesConventional diabetes therapyType 1 diabetesComplications (DCCT/EDIC) cohortEDIC studySimilar HbAComplications TrialHypoglycemia ratesLower HbADiabetes controlDCCT studyRisk factorsRelative riskHypoglycemiaLower riskNighttime is the worst time: Parental fear of hypoglycemia in young children with type 1 diabetes
Van Name MA, Hilliard ME, Boyle CT, Miller KM, DeSalvo DJ, Anderson BJ, Laffel LM, Woerner SE, DiMeglio LA, Tamborlane WV. Nighttime is the worst time: Parental fear of hypoglycemia in young children with type 1 diabetes. Pediatric Diabetes 2017, 19: 114-120. PMID: 28429581, PMCID: PMC5650950, DOI: 10.1111/pedi.12525.Peer-Reviewed Original Research
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 surveyClinical outcomes in youth beyond the first year of type 1 diabetes: Results of the Pediatric Diabetes Consortium (PDC) type 1 diabetes new onset (NeOn) study
Cengiz E, Cheng P, Ruedy KJ, Kollman C, Tamborlane WV, Klingensmith GJ, Gal RL, Silverstein J, Lee J, Redondo MJ, Beck RW, Consortium F. Clinical outcomes in youth beyond the first year of type 1 diabetes: Results of the Pediatric Diabetes Consortium (PDC) type 1 diabetes new onset (NeOn) study. Pediatric Diabetes 2016, 18: 566-573. PMID: 27758023, PMCID: PMC5397378, DOI: 10.1111/pedi.12459.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdolescentChildChild, PreschoolCohort StudiesDiabetes Mellitus, Type 1Diabetic KetoacidosisDisease ProgressionDrug MonitoringFemaleFollow-Up StudiesGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInsulinInsulin SecretionInsulin-Secreting CellsMaleProspective StudiesRiskSeverity of Illness IndexUnited StatesConceptsType 1 diabetesPercentage of participantsClinical outcomesDiabetic ketoacidosisGlycemic controlResidual endogenous insulin secretionCourse of T1D.Pediatric Diabetes ConsortiumYears of diabetesOnset StudyEndogenous insulin secretionOptimal glycemic controlTime of diagnosisDuration of T1DNew insulin analoguesNovel treatment strategiesAdjunctive pharmacologic agentsFirst yearPartial remissionDiabetes CenterInsulin doseYears postdiagnosisMonths postdiagnosisGlycated hemoglobinPharmacologic agentsResponse to Comment on Rickels et al. Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study. Diabetes Care 2016;39:264–270
Rickels MR, Ruedy KJ, Foster NC, Piché CA, Dulude H, Sherr JL, Tamborlane WV, Bethin KE, DiMeglio LA, Wadwa RP, Ahmann AJ, Haller MJ, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW. Response to Comment on Rickels et al. Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study. Diabetes Care 2016;39:264–270. Diabetes Care 2016, 39: e193-e194. PMID: 27660135, PMCID: PMC5033081, DOI: 10.2337/dci16-0025.Peer-Reviewed Original ResearchA cross‐sectional view of the current state of treatment of youth with type 2 diabetes in the USA: enrollment data from the Pediatric Diabetes Consortium Type 2 Diabetes Registry
Nambam B, Silverstein J, Cheng P, Ruedy KJ, Beck RW, Wadwa R, Klingensmith G, Willi SM, Wood JR, Bacha F, Thomas IH, Tamborlane WV, Consortium F. A cross‐sectional view of the current state of treatment of youth with type 2 diabetes in the USA: enrollment data from the Pediatric Diabetes Consortium Type 2 Diabetes Registry. Pediatric Diabetes 2016, 18: 222-229. PMID: 26970319, DOI: 10.1111/pedi.12377.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdolescentAdultChildCohort StudiesCombined Modality TherapyComorbidityCross-Sectional StudiesDiabetes Mellitus, Type 2Glycated HemoglobinHumansHyperglycemiaHypoglycemiaMedical RecordsPractice Patterns, Physicians'PrevalenceRegistriesRisk FactorsUnited StatesYoung AdultGlucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes
Sherr JL, Ruedy KJ, Foster NC, Piché CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care 2016, 39: 555-562. PMID: 26884472, PMCID: PMC4806770, DOI: 10.2337/dc15-1606.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntranasalAdolescentBlood GlucoseChildChild, PreschoolCohort StudiesCross-Over StudiesDiabetes Mellitus, Type 1Dose-Response Relationship, DrugDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleGlucagonHumansHypoglycemiaInjections, IntramuscularInsulinMaleNauseaPowdersConceptsIntramuscular glucagonType 1 diabetesIntranasal dosesIntranasal glucagonYounger cohortsWeight-based doseMin of dosingTreatment of hypoglycemiaDose-response relationshipTransient nauseaDl riseSevere hypoglycemiaGlucagon levelsIntranasal doseClinical centersPlasma glucosePharmacodynamic studiesHospital settingGlucagon preparationPotential efficacyGlucagonType 1Adverse effectsCohortAge range
2015
Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study
Rickels MR, Ruedy KJ, Foster NC, Piché CA, Dulude H, Sherr JL, Tamborlane WV, Bethin KE, DiMeglio LA, Wadwa RP, Ahmann AJ, Haller MJ, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW. Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study. Diabetes Care 2015, 39: 264-270. PMID: 26681725, PMCID: PMC4722945, DOI: 10.2337/dc15-1498.Peer-Reviewed Original ResearchConceptsInsulin-induced hypoglycemiaType 1 diabetesIntramuscular glucagonIntranasal glucagonSevere hypoglycemiaPlasma glucoseCrossover noninferiority trialTreatment of hypoglycemiaLoss of consciousnessReal-world managementDosing visitsGlucagon responseIntravenous insulinNoninferiority studyGlucagon administrationClinical centersFacial discomfortNoninferiority trialHospital settingGlucagon preparationHypoglycemiaTherapeutic insulinGlucagonType 1Mean timeAssessing Rates of Hypoglycemia as an End Point in Clinical Trials
Muchmore DB, Heinemann L, Tamborlane W, Wu XW, Fleming A. Assessing Rates of Hypoglycemia as an End Point in Clinical Trials. Diabetes Care 2015, 38: e160-e161. PMID: 26283738, DOI: 10.2337/dc15-0808.Peer-Reviewed Original Research