2020
Transforming 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 femaleDiabetesRegistryEnrollment