2023
Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes
Criego A, Carlson A, Brown S, Forlenza G, Bode B, Levy C, Hansen D, Hirsch I, Bergenstal R, Sherr J, Mehta S, Laffel L, Shah V, Bhargava A, Weinstock R, MacLeish S, DeSalvo D, Jones T, Aleppo G, Buckingham B, Ly T, Group F. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 26: 11-23. PMID: 37850941, PMCID: PMC10794844, DOI: 10.1089/dia.2023.0364.Peer-Reviewed Original ResearchConceptsAdolescents/adultsPivotal trialsInsulin delivery systemsSingle-arm multicenter trialYears of useClinical trial registrationType 1 diabetesLong-term safetyMonths of useLong-term useDiabetic ketoacidosisMulticenter trialSevere hypoglycemiaTRIAL REGISTRATIONGlycemic outcomesType 1Delivery systemExtension phaseMonthsTrialsTarget rangeAdultsHbA1cChildrenEpisodesPsychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers
Hood K, Polonsky W, MacLeish S, Levy C, Forlenza G, Criego A, Buckingham B, Bode B, Hansen D, Sherr J, Brown S, DeSalvo D, Mehta S, Laffel L, Bhargava A, Huyett L, Vienneau T, Ly T. Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers. Pediatric Diabetes 2023, 2023: 1-12. DOI: 10.1155/2023/8867625.Peer-Reviewed Original ResearchType 1 diabetesGlycemic outcomesInsulin delivery systemsPsychosocial outcomesSleep qualityDiabetes-related distressCaregivers of childrenRegression analysisBaseline characteristicsDelivery systemProspective studyClinical trialsLinear regression analysisPsychosocial measuresParticipant characteristicsDiabetesCaregiversOutcomesOmnipodChildrenAdolescentsTrialsMonthsAdditional benefitSignificant improvement
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
2012
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
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