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 rangeAdultsHbA1cChildrenEpisodesSafety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes
Pihoker C, Shulman D, Forlenza G, Kaiserman K, Sherr J, Thrasher J, Buckingham B, Kipnes M, Bode B, Carlson A, Lee S, Latif K, Liljenquist D, Slover R, Dai Z, Niu F, Shin J, Jonkers R, Roy A, Grosman B, Vella M, Cordero T, McVean J, Rhinehart A, Vigersky R, Bode B, Buckingham B, Carlson A, Casaubon L, Christiansen M, Cordero T, Garg S, Grosman B, Kaiserman K, Kipnes M, Latif K, Lee S, Liljenquist D, Lintereur L, Liu M, McVean J, Parikh N, Peng F, Pihoker C, Philis-Tsimikas A, Pop-Busui R, Reed J, Rhinehart A, Roy A, Sherr J, Shin J, Shulman D, Singh K, Slover R, Thrasher J, Vella M, Vigersky R, Wu D. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 25: 755-764. PMID: 37782145, DOI: 10.1089/dia.2023.0255.Peer-Reviewed Original ResearchConceptsDiabetic ketoacidosisSensor glucosePivotal trialsSevere hypoglycemiaPredictive low glucose managementSingle-arm studySensor-augmented pumpType 1 diabetesEnd of studyMean sensor glucoseEffectiveness endpointTreat populationGlycemic targetsGlucose targetsInvestigational centersPrimary safetyGlycemic outcomesMean TIRA1CType 1Higher TIRStudy periodClosed-loop useCoefficient of variationLower TBRGlycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor
Cordero T, Dai Z, Arrieta A, Niu F, Vella M, Shin J, Rhinehart A, McVean J, Lee S, Slover R, Forlenza G, Shulman D, Pop-Busui R, Thrasher J, Kipnes M, Christiansen M, Buckingham B, Pihoker C, Sherr J, Kaiserman K, Vigersky R, Group F. Glycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor. Diabetes Technology & Therapeutics 2023, 25: 652-658. PMID: 37252734, PMCID: PMC10460682, DOI: 10.1089/dia.2023.0123.Peer-Reviewed Original Research
2022
How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System
Polonsky WH, Hood KK, Levy CJ, MacLeish SA, Hirsch IB, Brown SA, Bode BW, Carlson AL, Shah VN, Weinstock RS, Bhargava A, Jones TC, Aleppo G, Mehta SN, Laffel LM, Forlenza GP, Sherr JL, Huyett LM, Vienneau TE, Ly TT, Group F. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System. Diabetes Research And Clinical Practice 2022, 190: 109998. PMID: 35853530, PMCID: PMC10901155, DOI: 10.1016/j.diabres.2022.109998.Peer-Reviewed Original ResearchConceptsType 1 diabetesPsychosocial outcomesTreatment satisfactionInsulin delivery systemsSleep qualityPsychosocial measuresParticipant characteristicsBaseline participant characteristicsDiabetes distressGlycemic outcomesProspective safetyEfficacy studiesLinear regression analysisDelivery systemAid useAdultsOutcomesOmnipodT1D.DiabetesRegression analysisMonthsSignificant improvementDistressMulticenter
2021
Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes
Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics 2021, 24: 178-189. PMID: 34694909, PMCID: PMC8971997, DOI: 10.1089/dia.2021.0319.Peer-Reviewed Original ResearchConceptsAdvanced hybrid closed-loop systemMulticenter single-arm studyPredictive low glucose managementDiabetic ketoacidosis eventsSingle-arm studySensor-augmented pumpType 1 diabetesWilcoxon signed-rank testStudy phaseKetoacidosis eventsTreat populationHybrid closed-loop systemMean A1CGlycemic targetsGlucose targetsPivotal trialsStudy endpointGlucose managementGlycemic outcomesSigned-rank testAge groupsStudy participantsType 1Safety eventsA1CReal-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 knowledgeOutcomesContinuous Ketone Monitoring Consensus Report 2021
Nguyen KT, Xu NY, Zhang JY, Shang T, Basu A, Bergenstal RM, Castorino K, Chen KY, Kerr D, Koliwad SK, Laffel LM, Mathioudakis N, Midyett LK, Miller JD, Nichols JH, Pasquel FJ, Prahalad P, Prausnitz MR, Seley JJ, Sherr JL, Spanakis EK, Umpierrez GE, Wallia A, Klonoff DC. Continuous Ketone Monitoring Consensus Report 2021. Journal Of Diabetes Science And Technology 2021, 16: 689-715. PMID: 34605694, PMCID: PMC9294575, DOI: 10.1177/19322968211042656.Peer-Reviewed Original ResearchConceptsDiabetic ketoacidosisMedical literaturePrevention of DKAAdvanced practice nursingAdult endocrinologyDiabetes Technology SocietyClinical trialsInsulin delivery systemsConsensus panelHuman trialsPractice nursingPediatric endocrinologyKetone monitoringPrivate practiceDiabetes technologyClinical chemistryKetone productionTrialsEndocrinologyDelivery systemReportConclusionKetoacidosisKetonuriaKetonemiaMulticenter 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
2020
Incident diabetes complications among women with type 1 diabetes based on parity
Polsky S, Foster NC, DuBose SN, Agarwal S, Lyons S, Peters AL, Uwaifo GI, DiMeglio LA, Sherr JL, Levy CJ. Incident diabetes complications among women with type 1 diabetes based on parity. The Journal Of Maternal-Fetal & Neonatal Medicine 2020, 35: 4629-4634. PMID: 33280471, DOI: 10.1080/14767058.2020.1858278.Peer-Reviewed Original ResearchConceptsType 1 diabetesParous womenNulliparous womenDiabetes complicationsRisk factorsHigher body mass indexAdverse lipid profileTriglyceride/HDLOverweight/obesityBody mass indexAdvanced nephropathyMass indexT1D ExchangeFirst pregnancyPregnant womenChildbirth QuestionnaireLipid profileCardiovascular diseaseComplicationsWomenHypertensionYear 5Further studiesSignificant differencesDiabetesEffect of Exercise and Meals on Continuous Glucose Monitor Data in Healthy Individuals Without Diabetes
DuBose SN, Li Z, Sherr JL, Beck RW, Tamborlane WV, Shah VN. Effect of Exercise and Meals on Continuous Glucose Monitor Data in Healthy Individuals Without Diabetes. Journal Of Diabetes Science And Technology 2020, 15: 593-599. PMID: 32064911, PMCID: PMC8120054, DOI: 10.1177/1932296820905904.Peer-Reviewed Original ResearchConceptsEffects of exerciseSensor glucose levelsHealthy individualsResistance exerciseNadir glucoseGlucose levelsNonobese body mass indexT1D Exchange Clinic NetworkPeak postprandial glucoseBody mass indexGlucose concentrationTime of mealsNadir glucose concentrationsConsumption of alcoholMass indexPostprandial glucoseNonexercise dayAerobic exerciseExercise dayClinic networkMean changeFuture therapiesDiabetesDexcom G6Glucose monitor data
2019
Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions
Sherr J, Buckingham BA, Forlenza G, Galderisi A, Ekhlaspour L, Wadwa RP, Carria L, Hsu L, Berget C, Peyser TA, Lee JB, O'Connor J, Dumais B, Huyett L, Layne JE, Ly TT. Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions. Diabetes Technology & Therapeutics 2019, 22: 174-184. PMID: 31596130, PMCID: PMC7047109, DOI: 10.1089/dia.2019.0286.Peer-Reviewed Original ResearchConceptsDaily physical activityPhysical activityFree-living conditionsPercentage timeMultiple daily injectionsType 1 diabetesRespective age groupsCohort of participantsHybrid closed-loop systemPrimary endpointDaily injectionsEligible participantsClosed-loop studiesPercentage of timeTherapy phaseInvestigational deviceNights of useAge groupsSensor glucoseType 1Home settingDlSignificant decreaseUsual routineAdults
2012
Effect of Pramlintide on Prandial Glycemic Excursions During Closed-Loop Control in Adolescents and Young Adults With Type 1 Diabetes
Weinzimer SA, Sherr JL, Cengiz E, Kim G, Ruiz JL, Carria L, Voskanyan G, Roy A, Tamborlane WV. Effect of Pramlintide on Prandial Glycemic Excursions During Closed-Loop Control in Adolescents and Young Adults With Type 1 Diabetes. Diabetes Care 2012, 35: 1994-1999. PMID: 22815298, PMCID: PMC3447854, DOI: 10.2337/dc12-0330.Peer-Reviewed Original ResearchConceptsGlycemic excursionsBG excursionsEffects of pramlintideBlood glucose excursionsAbsorption of insulinContent of mealsPreprandial injectionsInsulin levelsPostprandial glycemiaGlucose excursionsInsulin delivery systemsInsulin concentrationsGlucose riseManual bolusesInsulin feedbackPostprandial BGStudy daysPramlintideCL controlInsulin absorptionType 1Beneficial effectsSubcutaneous sitesTarget glucoseYoung adultsEffect of Insulin Feedback on Closed-Loop Glucose Control: A Crossover Study
Ruiz JL, Sherr JL, Cengiz E, Carria L, Roy A, Voskanyan G, Tamborlane WV, Weinzimer SA. Effect of Insulin Feedback on Closed-Loop Glucose Control: A Crossover Study. Journal Of Diabetes Science And Technology 2012, 6: 1123-1130. PMID: 23063039, PMCID: PMC3570847, DOI: 10.1177/193229681200600517.Peer-Reviewed Original ResearchConceptsBG excursionsPostprandial hypoglycemiaBG levelsMeal-related glucose excursionsInsulin deliveryLate postprandial hypoglycemiaTotal insulin deliveryOverall glycemic controlOccurrence of hypoglycemiaClosed-loop glucose controlMean BG levelClosed-loop insulin delivery systemAverage BG levelsBlood glucose responseSeparate admissionsGlycemic controlCrossover studyGlucose controlHypoglycemic eventsGlucose excursionsInsulin delivery systemsGlucose riseBG controlInsulin feedbackManual boluses
2010
Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes
Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. New England Journal Of Medicine 2010, 363: 311-320. PMID: 20587585, DOI: 10.1056/nejmoa1002853.Peer-Reviewed Original ResearchConceptsInjection therapy groupPump-therapy groupSensor-augmented pump therapyGlycated hemoglobin levelsHemoglobin levelsType 1 diabetesPump therapyBaseline glycated hemoglobin levelMultiple daily insulin injectionsType 1 diabetes mellitusGlycated haemoglobin targetPrimary end pointProportion of patientsDaily insulin injectionsSignificant weight gainRecombinant insulin analogueHemoglobin targetsInjection therapyDiabetes mellitusSevere hypoglycemiaInsulin injectionsClinical teamInsulin analoguesEnd pointTherapy