2021
Safety 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
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 routineAdults926-P: Frequency of Hypoglycemia by Gender in Healthy Individuals without Diabetes—Not So Different After All
DUBOSE S, LI Z, SHAH V, SHERR J, TAMBORLANE W, BERGENSTAL R, BECK R. 926-P: Frequency of Hypoglycemia by Gender in Healthy Individuals without Diabetes—Not So Different After All. Diabetes 2019, 68 DOI: 10.2337/db19-926-p.Peer-Reviewed Original ResearchHealthy individualsMedtronic MiniMedFrequency of hypoglycemiaDuration of hypoglycemiaEli LillyPercentage of participantsHelmsley Charitable TrustNon-Hispanic whitesBoehringer Ingelheim PharmaceuticalsRace/ethnicityTakeda Pharmaceutical Company LimitedNondiabetic childrenSanofi USAdvisory PanelMean HbA1cHypoglycemic eventsKidney diseaseMulticenter studyDiabetes careMore hypoglycemiaHarry B. Helmsley Charitable TrustPercentage of timeAverage glucoseDiabetesHypoglycemia
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