2023
Utility and precision evidence of technology in the treatment of type 1 diabetes: a systematic review
Jacobsen L, Sherr J, Considine E, Chen A, Peeling S, Hulsmans M, Charleer S, Urazbayeva M, Tosur M, Alamarie S, Redondo M, Hood K, Gottlieb P, Gillard P, Wong J, Hirsch I, Pratley R, Laffel L, Mathieu C. Utility and precision evidence of technology in the treatment of type 1 diabetes: a systematic review. Communications Medicine 2023, 3: 132. PMID: 37794113, PMCID: PMC10550996, DOI: 10.1038/s43856-023-00358-x.Peer-Reviewed Original ResearchType 1 diabetesTreatment of peopleSystematic reviewAdvanced hybrid closed-loop systemBaseline glycemic levelsSelf-care burdenOptimization of outcomesContinuous glucose monitoring systemHybrid closed-loop systemAdvanced complicationsStandard careGlucose monitoring systemHypoglycemia riskGlycemic levelsGlycemic variabilityDiabetes therapyDiabetesHealthcare teamInsulin pumpType 1Glucose monitoringInsulin deliveryDevice initiationBehavioral modificationFurther studiesGlycemic 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 ResearchConceptsBlood glucose measurementsGlycemic targetsHybrid closed-loop systemAdvanced hybrid closed-loop systemSerious adverse events
2022
92-OR: Persistence of Impaired Awareness of Hypoglycemia, Severe Hypoglycemic Events, and Suboptimal Glycemic Control Despite Advanced Diabetes Technologies
PETTUS J, LIU J, TITIEVSKY L, HAGAN K, LIU T, CHANDARANA K, GAGLIA J, WOLF W, BISPHAM J, CHAPMAN K, FINAN D, SHERR J. 92-OR: Persistence of Impaired Awareness of Hypoglycemia, Severe Hypoglycemic Events, and Suboptimal Glycemic Control Despite Advanced Diabetes Technologies. Diabetes 2022, 71 DOI: 10.2337/db22-92-or.Peer-Reviewed Original ResearchImpaired awareness of hypoglycemiaSevere hypoglycemic eventsRate of severe hypoglycemic eventsAwareness of hypoglycemiaGlycemic controlContinuous glucose monitoringHypoglycemic eventsPrevalence of impaired awareness of hypoglycemiaHybrid closed-loop systemProportion of patientsTarget glycemic controlNational Institute of DiabetesSuboptimal glycemic controlDigestive and Kidney DiseasesT1D Exchange RegistryPatient cohortMedical historyKidney diseaseNon-CGM usersSelf-reported medical historyT1D treatment
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 knowledgeOutcomes70-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 systemsSafety 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
2020
A Pilot Study of Youth With Type 1 Diabetes Initiating Use of a Hybrid Closed-Loop System While Receiving a Behavioral Economics Intervention
Nally LM, Wagner J, Sherr J, Tichy E, Weyman K, Ginley MK, Zajac K, Desousa M, Shabanova V, Petry NM, Tamborlane WV, Van Name M. A Pilot Study of Youth With Type 1 Diabetes Initiating Use of a Hybrid Closed-Loop System While Receiving a Behavioral Economics Intervention. Endocrine Practice 2020, 27: 545-551. PMID: 34120699, PMCID: PMC8206518, DOI: 10.1016/j.eprac.2020.11.017.Peer-Reviewed Original Research1296-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Children Aged 2-12 Years without Increasing Risk of Hypoglycemia
SHERR J, BUCKINGHAM B, FORLENZA G, GALDERISI A, EKHLASPOUR L, WADWA R, ZGORSKI M, KINGMAN R, BERGET C, LEE J, OCONNOR J, DUMAIS B, VIENNEAU T, HUYETT L, LY T. 1296-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Children Aged 2-12 Years without Increasing Risk of Hypoglycemia. Diabetes 2020, 69 DOI: 10.2337/db20-1296-p.Peer-Reviewed Original ResearchDiabetes careGlucose targetsEli LillySerious adverse eventsHigh-fat mealRisk of hypoglycemiaAdvisory PanelType 1 diabetesChildren Aged 2MannKind CorporationHybrid closed-loop systemT1D durationAdverse eventsT1D ExchangeFat mealGlucose managementMean glucosePivotal studiesAged 2Bolus challengeDaily exerciseInvestigational deviceDlPercent timeTarget glucose978-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Adults and Adolescents without Increasing Risk of Hypoglycemia
FORLENZA G, BUCKINGHAM B, SHERR J, WADWA R, GALDERISI A, EKHLASPOUR L, BERGET C, HSU L, ZGORSKI M, LEE J, OCONNOR J, DUMAIS B, VIENNEAU T, HUYETT L, LY T. 978-P: Omnipod Personalized MPC Algorithm at Target Glucose of 110mg/dl Is Safe in Adults and Adolescents without Increasing Risk of Hypoglycemia. Diabetes 2020, 69 DOI: 10.2337/db20-978-p.Peer-Reviewed Original ResearchDiabetes careMeal bolusEli LillyPercent timeRisk of hypoglycemiaAdvisory PanelType 1 diabetesHigh-fat dinnerMannKind CorporationHybrid closed-loop systemT1D durationGlucose targetsT1D ExchangeGlucose managementPivotal studiesDaily exerciseInvestigational deviceDlTarget glucoseCareLexicon PharmaceuticalsMedtronicBolusLower targetsAdults
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 routineAdults215-OR: Safety and Performance of the Omnipod Hybrid Closed-Loop System in Young Children Aged 2-6 Years with Type 1 Diabetes
BUCKINGHAM B, FORLENZA G, SHERR J, GALDERISI A, EKHLASPOUR L, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. 215-OR: Safety and Performance of the Omnipod Hybrid Closed-Loop System in Young Children Aged 2-6 Years with Type 1 Diabetes. Diabetes 2019, 68 DOI: 10.2337/db19-215-or.Peer-Reviewed Original ResearchDiabetes careMedtronic MiniMedSevere hypoglycemic eventsChildren Aged 2Advisory PanelYoung childrenMin/dAge 4.2Oral carbohydrateHybrid closed-loop systemHypoglycemic eventsGlycemic outcomesMean glucoseAged 2CGM useTherapy phaseInvestigational deviceType 1T1D therapyPercent timeMiniMedLexicon PharmaceuticalsCareUsual routineAdult participants
2018
Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adolescents with Type 1 Diabetes over Five Days Under Free-Living Conditions
FORLENZA G, BUCKINGHAM B, SHERR J, PEYSER T, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adolescents with Type 1 Diabetes over Five Days Under Free-Living Conditions. Diabetes 2018, 67 DOI: 10.2337/db18-1376-p.Peer-Reviewed Original ResearchModerate-intensity exerciseDiabetes careGlycemic outcomesFree-living conditionsType 1 diabetesMin/dAdvisory PanelHybrid closed-loop systemStandard therapyDays of useEligible participantsAge 14.3Percentage of timeCGM useInvestigational deviceMedtronic MiniMedType 1DlTime 70Usual routineCareEli LillyOmnipodAdolescentsConcomitant reductionSafety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Aged 6-12 Years with Type 1 Diabetes over Five Days Under Free-Living Conditions
SHERR J, FORLENZA G, BUCKINGHAM B, PEYSER T, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Aged 6-12 Years with Type 1 Diabetes over Five Days Under Free-Living Conditions. Diabetes 2018, 67 DOI: 10.2337/db18-1377-p.Peer-Reviewed Original ResearchModerate-intensity exerciseDiabetes careGlycemic outcomesFree-living conditionsType 1 diabetesChildren Aged 6Min/dAdvisory PanelAge 9.9Hybrid closed-loop systemStandard therapyDays of useEligible participantsPercentage of timeCGM useAged 6Investigational deviceMedtronic MiniMedType 1DlTime 70Usual routineCareEli LillyOmnipodSafety and Performance of the Omnipod® Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions
BUCKINGHAM B, SHERR J, FORLENZA G, PEYSER T, LEE J, OCONNOR J, DUMAIS B, HUYETT L, LAYNE J, LY T. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions. Diabetes 2018, 67 DOI: 10.2337/db18-207-or.Peer-Reviewed Original ResearchModerate-intensity exerciseDiabetes careGlycemic outcomesFree-living conditionsType 1 diabetesMin/dAdvisory PanelHybrid closed-loop systemStandard therapyDays of useEligible participantsPercentage of timeCGM useInvestigational deviceMedtronic MiniMedType 1DlTime 70Usual routineCareEli LillyOmnipodAdultsConcomitant reductionDays