2023
Safety 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 TBR
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
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
2009
From pumps to prevention: recent advances in the treatment of type 1 diabetes
Sherr J, Cengiz E, Tamborlane WV. From pumps to prevention: recent advances in the treatment of type 1 diabetes. Drug Discovery Today 2009, 14: 973-981. PMID: 19580883, DOI: 10.1016/j.drudis.2009.06.011.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAutoimmunityBiosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Drug Therapy, CombinationGlycated HemoglobinHumansHypoglycemic AgentsImmunologic FactorsInfusion PumpsInsulinInsulin-Secreting CellsPancreas, ArtificialPrimary PreventionTreatment OutcomeConceptsContinuous subcutaneous insulin infusionContinuous glucose monitoringType 1 diabetes mellitusBeta-cell destructionRapid-acting insulinSubcutaneous insulin infusionTreatment of T1DMType 1 diabetesBlood glucose fluctuationsImproved insulin deliveryAutoimmune processDiabetes mellitusPediatric patientsSecondary interventionsTreatment optionsInsulin infusionNew medicationsGlucose fluctuationsGlucose monitoringInsulin deliveryArtificial pancreasPreventionTreatmentInitial studyMellitus