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 rangeAdultsHbA1cChildrenEpisodes
2022
100-LB: Glycemic Control Using Recommended Settings in Youth and Adults with Type 1 Diabetes (T1D) —Minimed 780G System with the Calibration-Free Guardian 4 Sensor Results
VIGERSKY R, BODE B, BRAZG R, BUCKINGHAM B, CARLSON A, KAISERMAN K, KIPNES M, LILJENQUIST D, PHILIS-TSIMIKAS A, PIHOKER C, POP-BUSUI R, REED J, SHERR J, SHULMAN D, SLOVER R, THRASHER J, CHEN X, LIU M, CORDERO T, VELLA M, RHINEHART A, SHIN J. 100-LB: Glycemic Control Using Recommended Settings in Youth and Adults with Type 1 Diabetes (T1D) —Minimed 780G System with the Calibration-Free Guardian 4 Sensor Results. Diabetes 2022, 71 DOI: 10.2337/db22-100-lb.Peer-Reviewed Original ResearchMannKind CorporationSpeakers bureauKidney diseaseNovo NordiskEli LillyAdvisory PanelNational InstituteHealth researchMonths of useEffectiveness endpointReata PharmaceuticalsGlycemic controlPivotal trialsSevere hypoglycemiaEffectiveness outcomesGlycemic metricsDiabetesBayer AGHealth groupsRoche DiagnosticsUnitedHealth GroupLexicon PharmaceuticalsMiniMedTarget rangeSanofi
2021
Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Adults and Adolescents With Type 1 Diabetes (T1D)
Brown S, Levy C, Hirsch I, Bode B, Carlson A, Shah V, Pinsker J, Weinstock R, Bhargava A, Mehta S, Laffel L, Jones T, Sherr J, Aleppo G, Forlenza G, Ly T. Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Adults and Adolescents With Type 1 Diabetes (T1D). Journal Of The Endocrine Society 2021, 5: a671-a672. DOI: 10.1210/jendso/bvab048.1370.Peer-Reviewed Original ResearchStandard therapyType 1 diabetesDiabetic ketoacidosisSevere hypoglycemiaInsulin delivery systemsPivotal studiesLarge cohortTarget rangeEpisodes of DKAEpisodes of SHExtension phaseMultiple daily injectionsBurden of diseaseEnd of studyHours/dayMonths of useEffectiveness endpointBaseline A1CHybrid closed-loop systemPrevious therapyPrior therapyT1D durationGlucose targetsInsulin needsDaily injectionsSafety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D)
Buckingham B, Forlenza G, Criego A, Hansen D, Bode B, Brown S, MacLeish S, Pinsker J, DeSalvo D, Sherr J, Mehta S, Laffel L, Bhargava A, Ly T. Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D). Journal Of The Endocrine Society 2021, 5: a454-a454. PMCID: PMC8090047, DOI: 10.1210/jendso/bvab048.927.Peer-Reviewed Original ResearchDiabetic ketoacidosisSevere hypoglycemiaPercentage of timePivotal studiesLarge cohortEpisodes of DKAEpisodes of SHExtension phaseTarget rangeType 1 diabetesEnd of studyHours/dayMonths of useBaseline A1CEffectiveness endpointHybrid closed-loop systemNeurologic outcomePrevious therapyT1D durationStandard therapyGlucose targetsPediatric populationPrimary safetyGlycemic outcomesTreatment paradigm