2023
Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes
Pihoker C, Shulman D, Forlenza G, Kaiserman K, Sherr J, Thrasher J, Buckingham B, Kipnes M, Bode B, Carlson A, Lee S, Latif K, Liljenquist D, Slover R, Dai Z, Niu F, Shin J, Jonkers R, Roy A, Grosman B, Vella M, Cordero T, McVean J, Rhinehart A, Vigersky R, Bode B, Buckingham B, Carlson A, Casaubon L, Christiansen M, Cordero T, Garg S, Grosman B, Kaiserman K, Kipnes M, Latif K, Lee S, Liljenquist D, Lintereur L, Liu M, McVean J, Parikh N, Peng F, Pihoker C, Philis-Tsimikas A, Pop-Busui R, Reed J, Rhinehart A, Roy A, Sherr J, Shin J, Shulman D, Singh K, Slover R, Thrasher J, Vella M, Vigersky R, Wu D. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 25: 755-764. PMID: 37782145, DOI: 10.1089/dia.2023.0255.Peer-Reviewed Original ResearchConceptsDiabetic ketoacidosisSensor glucosePivotal trialsSevere hypoglycemiaPredictive low glucose managementSingle-arm studySensor-augmented pumpType 1 diabetesEnd of studyMean sensor glucoseEffectiveness endpointTreat populationGlycemic targetsGlucose targetsInvestigational centersPrimary safetyGlycemic outcomesMean TIRA1CType 1Higher TIRStudy periodClosed-loop useCoefficient of variationLower TBR
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
Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes
Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2021, 24: 178-189. PMID: 34694909, PMCID: PMC8971997, DOI: 10.1089/dia.2021.0319.Peer-Reviewed Original ResearchConceptsAdvanced hybrid closed-loop systemMulticenter single-arm studyPredictive low glucose managementDiabetic ketoacidosis eventsSingle-arm studySensor-augmented pumpType 1 diabetesWilcoxon signed-rank testStudy phaseKetoacidosis eventsTreat populationHybrid closed-loop systemMean A1CGlycemic targetsGlucose targetsPivotal trialsStudy endpointGlucose managementGlycemic outcomesSigned-rank testAge groupsStudy participantsType 1Safety eventsA1C