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
2021
Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT, Brown S, Voelmle M, Emory E, Forlenza G, Wadwa R, Slover R, Cobry E, Messer L, Berget C, McCoy S, Shah V, Akturk H, Schneider N, Joseph H, Joshee P, Beatson C, Bode B, Narron B, Lopez T, Pinsker J, Church M, Castorino K, Piper M, Perez J, Levy C, Lam D, Levister C, O’Malley G, Ogyaadu S, Arasaratnam D, Plesser M, Nosova E, Bzdick S, Hansen D, Stone S, Weinstock R, Hirsch I, Trikudanathan S, Sanborn N, Khakpour D, Carlson A, Criego A, Bergenstal R, Martens T, Grieme A, Hyatt J, Punel A, Whipple D, Sherr J, Van Name M, Brei M, Zgorski M, Steffen A, Carria L, Mehta S, Laffel L, Roethke L, Fisher M, La Banca R, Volkening L, Ambler-Osborn L, Turcotte C, Freiner E, Bhargava A, Borg L, MacLeish S, Wood J, Kaminski B, Casey T, Campbell W, DeSalvo D, McKay S, DeLaO M, Villegas C, Jones T, Johns B, Gore A, Harvill L, Merritt K, Stanfield J, Sheldon J, Hichkad L, Burnett E, Castelot A, Bounds L, Preston K, Goldfaden R, Aleppo G, Kravarusic J, Bansal A, Buckingham B, Ekhlaspour L, Kingman R, Kivilaid K, Kleve K, Ly T, Dumais B, Vienneau T, Huyett L, Lee J, O’Connor J, Benjamin E. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care 2021, 44: 1630-1640. PMID: 34099518, PMCID: PMC8323171, DOI: 10.2337/dc21-0172.Peer-Reviewed Original ResearchConceptsInsulin delivery systemsGlycemic targetsDiabetic ketoacidosis eventsPrimary safety outcomePrimary effectiveness outcomeSevere hypoglycemia eventsTarget glucose rangeBurden of diseaseType 1 diabetesPivotal safety studiesKetoacidosis eventsDiabetic ketoacidosisStandard therapyMulticenter trialSevere hypoglycemiaDelivery systemProspective studyHypoglycemia eventsTreatment paradigmAutomated Insulin Delivery SystemsSafety outcomesEffectiveness outcomesTherapy phaseSensor glucoseType 1