2024
Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod® 5 Automated Insulin Delivery System
DeSalvo D, Bode B, Forlenza G, Laffel L, Buckingham B, Criego A, Schoelwer M, MacLeish S, Sherr J, Hansen D, Ly T. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod® 5 Automated Insulin Delivery System. Diabetes Technology & Therapeutics 2024, 26: 383-393. PMID: 38277156, DOI: 10.1089/dia.2023.0506.Peer-Reviewed Original ResearchType 1 diabetesExtension phaseEpisodes of diabetic ketoacidosisEpisodes of severe hypoglycemiaLong-term safetyLong-term useStandard therapyDiabetic ketoacidosisAutomated insulin deliverySevere hypoglycemiaYoung childrenConclusion:</i></b>Continuous glucose monitoring metricsExtension studyMethods:</i></b>MonthsGlycemic outcomesTarget rangeTrialsOmnipodHbA1cInsulin deliveryDelivery systemInsulin delivery systemsEpisodesReal-World Evidence of Automated Insulin Delivery System Use
Considine E, Sherr J. Real-World Evidence of Automated Insulin Delivery System Use. Diabetes Technology & Therapeutics 2024, 26: 53-65. PMID: 38377315, PMCID: PMC10890954, DOI: 10.1089/dia.2023.0442.Peer-Reviewed Original ResearchConceptsGlucose management indicatorAid useRetrospective real-world studyMode of insulin deliveryGlycemic benefitsFollow-up periodTrial findingsFood and Drug AdministrationStandard of careReal-world studyInsulin deliveryType 1 diabetesNonpregnant individualsPivotal trialsRetrospective analysisPrimary outcomeHemoglobin A1cConclusion:</i></b>Drug AdministrationInclusion criteriaHbA1cGlycemic outcomesSystematic reviewResults:</i></b>Target range
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
Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System
DuBose SN, Bauza C, Verdejo A, Beck RW, Bergenstal RM, Sherr J, Levy C, Levister C, Lam D, O'Malley G, Ogyaadu S, Lovett J, Abram V, Kudva Y, McCrady Spitzer S, Reid C, Kumari K, Dadlani V, Goland R, Pollak S, Alvarez A, Zagoren E, Deliard J, Kruger D, Hunter H, Smith A, Remtema H, Hiers P, Albanese-O'Neill A, Haller M, Adams J, Greco M, Peters A, Harmel M, Weinstock R, Bzdick S, Bulger J, Agonstini L, Conboy P, Doolittle S, Aleppo G, Bansal A, Thompson M, Arsiniega E, Hubacz L, Monzavi R, Raymond J, Brimberry D, Torres Sanchez A, Simmons J, Rainer K, Brendle F, Williams G, Kelley J, Clements M, McDonough R, Watkins D, Elrod A, Seuferling B, Harding H, James J, Orlich S, Raman V, Foster C, Davis C, Slater H, Ocanovic Z, Kingery S, Wintergerst K, Watson S, Eubanks S, Pierce G, Rush H, Wong J, Dapkus L, Wood J, Adams R, Blomquist G, Sterchi L, Welch S, Gouine D, Racki S, Hodax J, Beauregard N, Pascual C, Franklin C, Bethin K, Majumdar I, Mastrandrea L, Quattrin T, Tabaczynski E, House A. Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System. Diabetes Technology & Therapeutics 2021, 23: 791-798. PMID: 34524023, DOI: 10.1089/dia.2021.0176.Peer-Reviewed Original ResearchConceptsHybrid closed-loop systemHybrid closed-loop insulin delivery systemMean percent timeRoutine clinical visitsPatient-reported outcomesType 1 diabetesClosed-loop insulin delivery systemUsual careClinical outcomesClinical visitsInsulin delivery systemsSleep interruptionClinical dataClinic dataType 1Glucose monitor dataPercent timeMonthsTarget rangePatientsContinuous glucose monitor dataAdequate trainingBaselineCurrent knowledgeOutcomesSafety 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