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 eventsA1C
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