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 phase
2021
Long-Term Complications in Youth-Onset Type 2 Diabetes
Bjornstad P, Drews K, Caprio S, Gubitosi-Klug R, Nathan D, Tesfaldet B, Tryggestad J, White N, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. New England Journal Of Medicine 2021, 385: 416-426. PMID: 34320286, PMCID: PMC8697255, DOI: 10.1056/nejmoa2100165.Peer-Reviewed Original ResearchConceptsType 2 diabetesDiabetic kidney diseaseNerve diseaseKidney diseaseRetinal diseasesYouth-Onset Type 2Minority raceDevelopment of complicationsIncidence of dyslipidemiaRisk of complicationsMulticenter clinical trialDiagnosis of diabetesMicrovascular complicationsAdverse eventsCumulative incidenceTerm complicationsGlycemic controlRelated complicationsObservational followMean ageRisk factorsClinical trialsComplicationsDyslipidemiaHypertension
2020
A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes.
Laffel L, Harrington K, Hanono A, Naik N, Ambler-Osborn L, Schultz A, DiMeglio L, Woerne S, Jolivette H, Ismail H, Tebbe M, Newman A, Legge M, Tamborlane W, Van Name M, Weyman K, Finnegan J, Steffen A, Zgorski M, DeSalvo D, Hilliard M, DeLaO K, Xie C, Levy W, Wadwa R, Forlenza G, Majidi S, Alonso G, Weber I, Clay M, Simmons E, Nathan B, Sunni M, Sweet J, Pappenfus B, Kogler A, Ludwig M, Nelson B, Street A, Weingartner D, Albanese-O’Neill A, Haller M, Adams J, Cintron M, Thomas N, Kelley J, Simmons J, William G, Brendle F, Goland R, Williams K, Gandica R, Pollak S, Casciano E, Robinson E, Willi S, Minnock P, Olivos D, Carchidi C, Grant B, Wong J, Adi S, Corathers S, Sheanon N, Fox C, Weis T, MacLeish S, Wood J, Casey T, Campbell W, McGuigan P, Wintergerst K, Watson S, Kingery S, Pierce G, Ruch H, Rayborn L, Rodriguez-Luna M, Deuser A. A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes. Diabetes Care 2020, 44: 464-472. PMID: 33334807, PMCID: PMC9162100, DOI: 10.2337/dc20-1060.Peer-Reviewed Original ResearchConceptsType 1 diabetesBlood glucose monitoringContinuous glucose monitoringFamily behavioral interventionsGlucose monitoringFingerstick blood glucose monitoringBehavioral interventionsSevere hypoglycemic eventsDays/weekYears of ageFear of hypoglycemiaYoung childrenTreatment group comparisonsChildren ages 2Very Young ChildrenHypoglycemic eventsCGM groupDiabetes burdenClinical trialsGlycemic outcomesGlucose levelsPrimary analysisDiabetesBGM groupPercent timeTransforming Performance of Clinical Trials in Pediatric Type 2 Diabetes: A Consortium Model
Van Name M, Klingensmith G, Nelson B, Wintergerst K, Mitchell J, Norris K, Tamborlane W, Clements M, Hannon T, Shoemaker A, Wood J, Gal R. Transforming Performance of Clinical Trials in Pediatric Type 2 Diabetes: A Consortium Model. Diabetes Technology & Therapeutics 2020, 22: 330-336. PMID: 31859529, PMCID: PMC7869879, DOI: 10.1089/dia.2019.0448.Peer-Reviewed Original ResearchConceptsPediatric Diabetes ConsortiumType 2 diabetesClinical centersCoordinating CenterPediatric treatment centerPediatric type 1 diabetesPhase 3 trialType 2 Diabetes StudyType 1 diabetesPediatric Type 2Diabetes-related studiesTreatment of youthPivotal trialsRandomized subjectsDiabetes StudyStudy protocolClinical trialsContract research organizationsConsortium modelTreatment centersType 2DiabetesNew drugsTrialsEnrollment strategies
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