2024
Endpoints for clinical trials in type 1 diabetes drug development
Galderisi A, Marks B, DiMeglio L, de Beaufort C. Endpoints for clinical trials in type 1 diabetes drug development. The Lancet Diabetes & Endocrinology 2024, 12: 297-299. PMID: 38663944, PMCID: PMC11230104, DOI: 10.1016/s2213-8587(24)00097-4.Peer-Reviewed Original Research
2023
A New Index of Insulin Sensitivity from Glucose Sensor and Insulin Pump Data: In Silico and In Vivo Validation in Youths with Type 1 Diabetes
Schiavon M, Galderisi A, Basu A, Kudva Y, Cengiz E, Man C. A New Index of Insulin Sensitivity from Glucose Sensor and Insulin Pump Data: In Silico and In Vivo Validation in Youths with Type 1 Diabetes. Diabetes Technology & Therapeutics 2023, 25: 270-278. PMID: 36648253, PMCID: PMC10066780, DOI: 10.1089/dia.2022.0397.Peer-Reviewed Original Research
2022
ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Insulin delivery
Sherr J, Schoelwer M, Dos Santos T, Reddy L, Biester T, Galderisi A, van Dyk J, Hilliard M, Berget C, DiMeglio L. ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Insulin delivery. Pediatric Diabetes 2022, 23: 1406-1431. PMID: 36468192, DOI: 10.1111/pedi.13421.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsSGLT2i Improves Glycemic Control in Patients With Congenital Severe Insulin Resistance.
Galderisi A, Tamborlane W, Taylor SI, Attia N, Moretti C, Barbetti F. SGLT2i Improves Glycemic Control in Patients With Congenital Severe Insulin Resistance. Pediatrics 2022, 150 PMID: 35652305, DOI: 10.1542/peds.2021-055671.Peer-Reviewed Original ResearchConceptsRabson-Mendenhall syndromeGlycemic controlHemoglobin A1cRenal calcium excretionInsulin-resistant diabetesSevere insulin resistanceCalcium excretionUrinary calciumAntidiabetic treatmentDay doseDose escalationSecond patientFirst patientInsulin levelsInsulin resistanceUrinary excretionSerum glucosePatientsEmpagliflozinMild increaseDapagliflozinΒ-hydroxybutyrateTarget rangeA1CExcretionIntraperitoneal Insulin Delivery: Evidence of a Physiological Route for Artificial Pancreas From Compartmental Modeling
Presti J, Galderisi A, Doyle F, Zisser H, Dassau E, Renard E, Toffanin C, Cobelli C. Intraperitoneal Insulin Delivery: Evidence of a Physiological Route for Artificial Pancreas From Compartmental Modeling. Journal Of Diabetes Science And Technology 2022, 17: 751-756. PMID: 35144503, PMCID: PMC10210098, DOI: 10.1177/19322968221076559.Peer-Reviewed Original ResearchConceptsInsulin deliveryClosed-loop insulin deliveryInsulin kineticsIntraperitoneal insulin deliveryPeripheral hyperinsulinemiaGlycemic controlSubcutaneous routePeritoneal compartmentModel predictive controllerPhysiological routeArtificial pancreasCompartmental modelingDeliveryUVA/Padova T1D simulatorCompartmental modelProportional integral derivative (PID) controllerHyperinsulinemia
2020
Effect of Afrezza on Glucose Dynamics During HCL Treatment
Galderisi A, Cohen N, Calhoun P, Kraemer K, Breton M, Weinzimer S, Cengiz E. Effect of Afrezza on Glucose Dynamics During HCL Treatment. Diabetes Care 2020, 43: 2146-2152. PMID: 32661108, PMCID: PMC7440894, DOI: 10.2337/dc20-0091.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, InhalationAdolescentAdultBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesDiabetes Mellitus, Type 1Dose-Response Relationship, DrugEquipment and SuppliesFemaleGlycemic ControlHumansHypoglycemic AgentsInsulin Infusion SystemsInsulin, Regular, HumanMaleMealsPostprandial PeriodYoung AdultConceptsControl armPremeal bolusesPostprandial plasma glucose levelsPostprandial blood glucose controlPrimary efficacy outcomeRapid-acting insulinBlood glucose controlPlasma glucose levelsType 1 diabetesLater time pointsSequential mealsEfficacy outcomesPPG levelsSecondary outcomesGlycemic excursionsMeal studyGlucose controlSubcutaneous routeInsulin delivery systemsGlucose levelsGlucose metricsHigh doseStudy daysInsulin absorptionInsulin bolus
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 routineAdultsA Technological Revolution: The Integration of New Treatments to Manage Type 1 Diabetes.
Galderisi A, Sherr JL. A Technological Revolution: The Integration of New Treatments to Manage Type 1 Diabetes. Pediatric Annals 2019, 48: e311-e318. PMID: 31426099, DOI: 10.3928/19382359-20190725-03.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsContinuous glucose monitoringType 1 diabetesGlycemic controlContinuous subcutaneous insulin infusion pumpClosed-loop insulin deliveryIntensive insulin treatmentMultiple daily injectionsChronic medical conditionsLoop insulin deliveryPediatric clinical practiceInsulin infusion pumpDaily injectionsBlood glucoseInsulin treatmentMedical conditionsDiabetes treatmentClinical practiceNew treatmentsGlucose monitoringInfusion pumpInsulin deliveryT1DDiabetesTreatmentSuspension device
2016
Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe
Del Favero S, Boscari F, Messori M, Rabbone I, Bonfanti R, Sabbion A, Iafusco D, Schiaffini R, Visentin R, Calore R, Moncada Y, Galasso S, Galderisi A, Vallone V, Di Palma F, Losiouk E, Lanzola G, Tinti D, Rigamonti A, Marigliano M, Zanfardino A, Rapini N, Avogaro A, Chernavvsky D, Magni L, Cobelli C, Bruttomesso D. Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe. Diabetes Care 2016, 39: 1180-1185. PMID: 27208335, DOI: 10.2337/dc15-2815.Peer-Reviewed Original ResearchConceptsSensor-augmented pumpCrossover trialMean glucoseArtificial pancreasType 1 diabetesArtificial Pancreas ProjectWearable artificial pancreasAP trialOlder childrenTrialsHypoglycemiaYoung childrenChildrenPancreasOvernight timeSignificant changesGlucoseDaysDiabetesOutpatientsResearch designThreefold reduction
2010
Not every child with diabetes needs insulin
Iafusco D, Scaramuzza A, Galderisi A, Cocca A, Giugliano R, Zuccotti G, Prisco F. Not every child with diabetes needs insulin. The BMJ 2010, 341: c6512. PMID: 21081621, DOI: 10.1136/bmj.c6512.Commentaries, Editorials and Letters