2022
A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes
Reiss AL, Jo B, Arbelaez AM, Tsalikian E, Buckingham B, Weinzimer SA, Fox LA, Cato A, White NH, Tansey M, Aye T, Tamborlane W, Englert K, Lum J, Mazaika P, Foland-Ross L, Marzelli M, Mauras N. A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes. Nature Communications 2022, 13: 4940. PMID: 36042217, PMCID: PMC9427757, DOI: 10.1038/s41467-022-32289-x.Peer-Reviewed Original ResearchConceptsHybrid closed-loop insulin delivery systemStandard care groupType 1 diabetesClosed-loop insulin delivery systemWhite matter volumeCare groupPrimary outcomeInsulin delivery systemsMatter volumeFractional anisotropyCognitive AssessmentRigorous glucose controlDiagnosis of T1DClosed-loop groupBetter diabetes controlDiabetes care groupsConcept pilot studyYears of ageAcademic medical centerFunctional brain activityCortical surface areaMonths study durationRandomized participantsDiabetes controlGlucose controlEfficacy 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 personnelYouth with type 2 diabetes have a high rate of treatment failure after discontinuation of insulin: A Pediatric Diabetes Consortium study
Wolf RM, Cheng P, Gal RL, Beaulieu LC, Kollman C, Isganaitis E, Magge S, Mastrandrea LD, Klingensmith GJ, Tamborlane W, Van Name M, Consortium P. Youth with type 2 diabetes have a high rate of treatment failure after discontinuation of insulin: A Pediatric Diabetes Consortium study. Pediatric Diabetes 2022, 23: 439-446. PMID: 35138021, DOI: 10.1111/pedi.13325.Peer-Reviewed Original ResearchConceptsIntensive lifestyle interventionTreatment failureType 2 diabetesDiabetes medicationsLifestyle interventionGlycemic controlDiscontinuation of insulinExperienced treatment failureInitial insulin treatmentYouth-onset T2DHigh rateMetformin monotherapyPrimary outcomeMedian timeRisk factorsInsulin treatmentMetforminProgressive natureConsortium studyLogistic regressionInsulinT2DIntensive lifestyleMedicationsDiabetes
2017
Continuous 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 weight
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
2014
Reversal of Early Abnormalities in Glucose Metabolism in Obese Youth: Results of an Intensive Lifestyle Randomized Controlled Trial
Savoye M, Caprio S, Dziura J, Camp A, Germain G, Summers C, Li F, Shaw M, Nowicka P, Kursawe R, DePourcq F, Kim G, Tamborlane WV. Reversal of Early Abnormalities in Glucose Metabolism in Obese Youth: Results of an Intensive Lifestyle Randomized Controlled Trial. Diabetes Care 2014, 37: 317-324. PMID: 24062325, PMCID: PMC3898759, DOI: 10.2337/dc13-1571.Peer-Reviewed Original ResearchConceptsStandard of careClinical careBlood glucoseObese adolescentsObese youthOral glucose tolerance test glucoseIntensive lifestyle modificationDiabetes Prevention ProgramStandard clinical careInsulin sensitivity indexHealthy lifestyle programType 2 diabetesRisk of T2DChildhood obesity epidemicΒ-cell dysfunctionLifestyle modificationControlled TrialsOGTT glucosePrimary outcomeGlucose toleranceInsulin resistanceLifestyle programAnthropometric assessmentEarly abnormalitiesGlucose levels
2013
Effectiveness of Early Intensive Therapy on β-Cell Preservation in Type 1 Diabetes
Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV, . Effectiveness of Early Intensive Therapy on β-Cell Preservation in Type 1 Diabetes. Diabetes Care 2013, 36: 4030-4035. PMID: 24130350, PMCID: PMC3836135, DOI: 10.2337/dc13-1074.Peer-Reviewed Original ResearchConceptsUsual care groupC-peptide concentrationsType 1 diabetesΒ-cell functionHybrid closed-loop controlSAP therapyPump therapyContinuous glucose monitorNew-onset type 1 diabetesPeak C-peptide concentrationMixed-meal tolerance testSensor-augmented pump therapyEarly intensive therapyΒ-cell preservationUsual care participantsDays of diagnosisC-peptide areaMultiple daily injectionsInsulin pump therapyDays/weekMean glucose concentrationMedian durationIntensive therapyPrimary outcomeDaily injections
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
2011
Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study Results from the 6-month continuation phase
Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Perkins BA, Welsh JB, Willi SM, Wood MA, . Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study Results from the 6-month continuation phase. Diabetes Care 2011, 34: 2403-2405. PMID: 21933908, PMCID: PMC3198292, DOI: 10.2337/dc11-1248.Peer-Reviewed Original Research
2008
Continuous 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