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 170-OR: Evaluation of the Omnipod 5 Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes (T1D)
SHERR J, BODE B, FORLENZA G, LAFFEL L, BROWN S, BUCKINGHAM B, CRIEGO A, DESALVO D, MACLEISH S, HANSEN D, LY T. 70-OR: Evaluation of the Omnipod 5 Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes (T1D). Diabetes 2021, 70 DOI: 10.2337/db21-70-or.Peer-Reviewed Original ResearchDiabetes careDiabetic ketoacidosisStandard therapySevere hypoglycemiaSpeakers bureauEli LillyYoung childrenPrimary safety outcomePrimary effectiveness outcomeSerious adverse eventsAdvisory PanelLexicon PharmaceuticalsDaily dose requirementsType 1 diabetesNovo NordiskBoehringer Ingelheim PharmaceuticalsMannKind CorporationPermissive hyperglycemiaBaseline characteristicsHybrid closed-loop systemT1D durationAdverse eventsGlucose targetsEfficacy analysisInsulin delivery systemsDiabetes prevention in the Caribbean using Lifestyle Intervention and Metformin Escalation (LIME): Protocol for a hybrid Type-1 effectiveness-implementation trial using a quasi-experimental study design
Hassan S, Sobers N, Paul-Charles J, Herbert J, Dharamraj K, Cruz E, Garcia E, Fredericks L, Desai MM, Roy S, Williams S, Linnander E, Crusto C, Horowitz CR, Arniella G, Cattamanchi A, Adams OP, Nunez-Smith M. Diabetes prevention in the Caribbean using Lifestyle Intervention and Metformin Escalation (LIME): Protocol for a hybrid Type-1 effectiveness-implementation trial using a quasi-experimental study design. Contemporary Clinical Trials Communications 2021, 22: 100750. PMID: 33997458, PMCID: PMC8095103, DOI: 10.1016/j.conctc.2021.100750.Peer-Reviewed Original ResearchDiabetes prevention interventionPrevention interventionsLifestyle interventionHybrid type 1 effectiveness-implementation trialPrimary effectiveness outcomeIncidence of diabetesEffectiveness-implementation trialType 2 diabetesHigh-risk individualsQuasi-experimental study designMetformin medicationMetformin prescribingIntervention armEligible participantsLifestyle changesProportion of individualsEffectiveness outcomesQuasi-experimental studyClinical sitesPrediabetesClinical settingStudy designInterventionDiabetesIndividuals
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