2023
Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12‐Month Follow‐Up Results
Miller K, Bauza C, Kanapka L, Clements M, DeSalvo D, Hood K, Messer L, Sherr J, Bergamo K, Criego A, Freiner E, Lyons S, Monzavi R, Moore W, Prahalad P, Simmons J, Sulik M, Wadwa R, Weinstock R, Willi S, Williams K, Laffel L, Group F. Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12‐Month Follow‐Up Results. Pediatric Diabetes 2023, 2023: 1-12. DOI: 10.1155/2023/6718115.Peer-Reviewed Original ResearchType 1 diabetesMedian percent timeUse of CGMBlood glucose monitoringYoung adultsCGM initiationExtension phaseGlucose monitoringPercent timeContinuous glucose monitoringMean hemoglobinGlycemic controlCGM groupUp ResultsClinical trialsGlycemic outcomesGlycemic benefitsCGM useMonitoring interventionsType 1Further evaluationBGM groupWeeksDlAdults
2022
Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial
Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT, Sherr J, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode B, Busby A, Forlenza G, Wadwa R, Slover R, Cobry E, Messer L, Laffel L, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown S, Krauthause K, Emory E, Oliveri M, Buckingham B, Ekhlaspour L, Kingman R, Criego A, Schwartz B, Gandrud L, Grieme A, Hyatt J, DeSalvo D, McKay S, DeLaO K, Villegas C, MacLeish S, Wood J, Kaminski B, Casey T, Campbell W, Behm K, Adams R, Hansen D, Stone S, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly T, Dumais B, Vienneau T, Huyett L, Lee J, O’Connor J, Benjamin E. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care 2022, 45: 1907-1910. PMID: 35678724, PMCID: PMC9346983, DOI: 10.2337/dc21-2359.Peer-Reviewed Original ResearchConceptsInsulin delivery systemsSingle-arm studyLong-term complicationsMulticenter clinical trialType 1 diabetesSensor glucose levelsYoung childrenBaseline data collectionReduced hypoglycemiaDiabetic ketoacidosisGlycemic targetsUsual therapyGlycemic measuresSevere hypoglycemiaDelivery systemStudy endGlycemic outcomesClinical trialsGlucose levelsType 1HypoglycemiaInvestigational systemDlChildrenStudy phase
2020
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
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 routineAdults
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