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 ResearchClinical Trials as TopicDiabetes Mellitus, Type 1Drug DevelopmentEndpoint DeterminationHumansHypoglycemic Agents
2023
Quantifying beta cell function in the preclinical stages of type 1 diabetes
Galderisi A, Carr A, Martino M, Taylor P, Senior P, Dayan C. Quantifying beta cell function in the preclinical stages of type 1 diabetes. Diabetologia 2023, 66: 2189-2199. PMID: 37712956, PMCID: PMC10627950, DOI: 10.1007/s00125-023-06011-5.Peer-Reviewed Original ResearchMeSH KeywordsBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Glucose Tolerance TestHumansInsulinInsulin ResistanceInsulin-Secreting CellsConceptsType 1 diabetesBeta-cell functionInsulin secretionFunctional beta-cell massEarly pre-symptomatic stagesCell functionPre-symptomatic phaseBeta-cell massDisease-modifying interventionsPre-symptomatic stageContinuous glucose monitoringIslet autoimmunityInsulin sensitivityDisease progressionGlucose profilesInvasive measuresPreclinical stageMetabolic testsProgressive lossDiabetesMetabolic changesGlucose monitoringAvailable testsMeasurable changesOGTTBeta cell function in the early stages of type 1 diabetes: still a long way ahead of us
Galderisi A. Beta cell function in the early stages of type 1 diabetes: still a long way ahead of us. Pediatric Endocrinology Diabetes And Metabolism 2023, 29: 1-3. PMID: 37218722, PMCID: PMC10226454, DOI: 10.5114/pedm.2023.126360.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAutoimmunityC-PeptideDiabetes Mellitus, Type 1HumansInsulin SecretionInsulin-Secreting CellsConceptsBeta-cell functionType 1 diabetesIslet autoimmunityCell functionFunctional beta-cell massDisease-modifier drugsUnderlying autoimmune processPre-symptomatic phaseBeta-cell massSymptomatic diabetesAutoimmune processClinical onsetSurrogate markerDiabetes progressionC-peptideInsulin secretionModifier drugsEarly changesDiabetesMetabolic changesDysglycaemiaAutoimmunityT1DOnsetModifier treatmentAnswering clinically pertinent questions with real-world data from paediatric type 1 diabetes registries
Galderisi A, Sherr J. Answering clinically pertinent questions with real-world data from paediatric type 1 diabetes registries. The Lancet Diabetes & Endocrinology 2023, 11: 300-301. PMID: 37004711, DOI: 10.1016/s2213-8587(23)00085-2.Commentaries, Editorials and LettersA 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
β-Cell Function and Insulin Sensitivity in Youth With Early Type 1 Diabetes From a 2-Hour 7-Sample OGTT
Galderisi A, Evans-Molina C, Martino M, Caprio S, Cobelli C, Moran A. β-Cell Function and Insulin Sensitivity in Youth With Early Type 1 Diabetes From a 2-Hour 7-Sample OGTT. The Journal Of Clinical Endocrinology & Metabolism 2022, 108: 1376-1386. PMID: 36546354, PMCID: PMC10188312, DOI: 10.1210/clinem/dgac740.Peer-Reviewed Original ResearchAdolescentBlood GlucoseDiabetes Mellitus, Type 1Glucose Tolerance TestHumansInsulinInsulin ResistanceInsulin-Secreting CellsISPAD 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 StatementsIntraperitoneal 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 ResearchMeSH KeywordsAdultAlgorithmsBlood GlucoseDiabetes Mellitus, Type 1Epidemiological ModelsHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsInsulin, Regular, HumanPancreas, ArtificialConceptsInsulin deliveryClosed-loop insulin deliveryInsulin kineticsIntraperitoneal insulin deliveryPeripheral hyperinsulinemiaGlycemic controlSubcutaneous routePeritoneal compartmentModel predictive controllerPhysiological routeArtificial pancreasCompartmental modelingDeliveryUVA/Padova T1D simulatorCompartmental modelProportional integral derivative (PID) controllerHyperinsulinemia
2021
Early Impairment of Insulin Sensitivity, β-Cell Responsiveness, and Insulin Clearance in Youth with Stage 1 Type 1 Diabetes
Galderisi A, Moran A, Evans-Molina C, Martino M, Santoro N, Caprio S, Cobelli C. Early Impairment of Insulin Sensitivity, β-Cell Responsiveness, and Insulin Clearance in Youth with Stage 1 Type 1 Diabetes. The Journal Of Clinical Endocrinology & Metabolism 2021, 106: 2660-2669. PMID: 34000022, PMCID: PMC8372628, DOI: 10.1210/clinem/dgab344.Peer-Reviewed Original ResearchConceptsOral glucose tolerance testΒ-cell responsivenessInsulin secretion rateΒ-cell functionInsulin sensitivityInsulin clearanceIslet autoantibodiesGlucose toleranceMultiple islet autoantibodiesOGTT glucose concentrationsPlasma insulin AUCImpaired glucose toleranceNormal glucose toleranceGlucose tolerance testType 1 diabetesReduced insulin sensitivityRatio of AUCOral minimal modelLean youthInsulin AUCClinical onsetInsulin levelsDisposition indexPresymptomatic phaseTolerance testPrevalence of psoriasis in a cohort of children and adolescents with type 1 diabetes
Caroppo F, Galderisi A, Moretti C, Ventura L, Fortina A. Prevalence of psoriasis in a cohort of children and adolescents with type 1 diabetes. Journal Of The European Academy Of Dermatology And Venereology 2021, 35: e589-e591. PMID: 33914987, DOI: 10.1111/jdv.17318.Peer-Reviewed Original Research
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
2017
Metabolomics reveals new metabolic perturbations in children with type 1 diabetes
Galderisi A, Pirillo P, Moret V, Stocchero M, Gucciardi A, Perilongo G, Moretti C, Monciotti C, Giordano G, Baraldi E. Metabolomics reveals new metabolic perturbations in children with type 1 diabetes. Pediatric Diabetes 2017, 19: 59-67. PMID: 28401628, DOI: 10.1111/pedi.12524.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentCase-Control StudiesChildDiabetes Mellitus, Type 1FemaleHumansMaleMetabolomeMetabolomicsConceptsBody mass indexType 1 diabetesHealthy controlsPubertal statusExcess of cortisolMetabolome of childrenPediatric diabetes clinicMacrovascular complicationsDiabetes clinicDisease durationNeuronal damagePediatric patientsClinical featuresMass indexCase groupTryptophan catabolitesHealthy peersUrinary metabolitesUrinary samplesBacterial productsT1DUntargeted metabolomics approachMetabolic perturbationsDiabetesPatients
2016
High frequency of diabetic ketoacidosis at diagnosis of type 1 diabetes in Italian children: a nationwide longitudinal study, 2004–2013
Cherubini V, Skrami E, Ferrito L, Zucchini S, Scaramuzza A, Bonfanti R, Buono P, Cardella F, Cauvin V, Chiari G, d′Annunzio G, Frongia A, Iafusco D, Patera I, Toni S, Tumini S, Rabbone I, Lombardo F, Carle F, Gesuita R, Lera R, De Luna L, Gualtieri A, Zecchino C, Piccinno E, Reinstadler P, Prandi E, Gallo F, Morganti G, Ripoli C, La Loggia A, Scanu P, Cardinale G, Tomaselli L, Citriniti F, Lazzaro N, De Donno V, Mainetti B, Coccioli M, Maccioni R, Marongiu U, Bruzzese M, Iannilli A, Pardi D, Confetto S, Zanfardino A, Iughetti L, Franzese A, Cadario F, Milia A, Piredda G, Soro M, Correddu A, Galderisi A, De Berardinis F, Federico G, Zanette G, Suprani T, Pedini A, Bitti M, Delvecchio M, Trada M, Meloni G, Gaiero A, Bulciolu P, Guerraggio L, Faleschini E, Zanatta M, Salvatoni A, Maffeis C, Arnaldi C. High frequency of diabetic ketoacidosis at diagnosis of type 1 diabetes in Italian children: a nationwide longitudinal study, 2004–2013. Scientific Reports 2016, 6: 38844. PMID: 27991500, PMCID: PMC5171855, DOI: 10.1038/srep38844.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAge FactorsDiabetes Mellitus, Type 1Diabetic KetoacidosisFemaleHumansItalyLongitudinal StudiesMaleConceptsSevere diabetic ketoacidosisDiabetic ketoacidosisType 1 diabetesDKA frequencyAge groupsLongitudinal population-based studyType 1 diabetes diagnosisMultiple logistic regression modelPopulation-based studyNationwide longitudinal studyYears of ageLogistic regression modelsItalian childrenFamily historyHigh riskMild/Diabetes diagnosisKetoacidosisHealthcare strategiesYoung age childrenDiabetesEarly detectionDiagnosisLongitudinal studyTime trendsEvaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting
Troncone A, Bonfanti R, Iafusco D, Rabbone I, Sabbion A, Schiaffini R, Galderisi A, Marigliano M, Rapini N, Rigamonti A, Tinti D, Vallone V, Zanfardino A, Boscari F, Del Favero S, Galasso S, Lanzola G, Messori M, Di Palma F, Visentin R, Calore R, Leal Y, Magni L, Losiouk E, Chernavvsky D, Quaglini S, Cobelli C, Bruttomesso D. Evaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting. Diabetes Care 2016, 39: 2158-2164. PMID: 27852685, DOI: 10.2337/dc16-1073.Peer-Reviewed Original ResearchRandomized 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 reductionThe long-term treatment of a patient with type 1 diabetes mellitus and glutaric aciduria type 1: the effect of insulin
Del Rizzo M, Galderisi A, Celato A, Furlan F, Giordano L, Cazzorla C, Fasan I, Moretti C, Zschocke J, Burlina A. The long-term treatment of a patient with type 1 diabetes mellitus and glutaric aciduria type 1: the effect of insulin. European Journal Of Pediatrics 2016, 175: 1123-1128. PMID: 26847429, DOI: 10.1007/s00431-016-2699-5.Peer-Reviewed Case Reports and Technical NotesConceptsType 1 diabetes mellitusGlutaric aciduria type 1Diabetes mellitusType 1Metabolic disordersInsulin daily doseIrreversible neuronal damageLong-term treatmentSimilar pathogenic mechanismsDifferent metabolic disordersBilateral striatal necrosisMonths of ageEffect of insulinAcute hypotoniaClassical T1DMLimb dystoniaNeurological outcomeInfective episodesNeuronal injuryDaily doseNeuronal damageDystonic movementsHypoglycemic episodesCarnitine supplementationGlycemic profile
2015
Cardiac Autoimmunity as a Novel Biomarker, Mediator, and Therapeutic Target of Heart Disease in Type 1 Diabetes
Lipes M, Galderisi A. Cardiac Autoimmunity as a Novel Biomarker, Mediator, and Therapeutic Target of Heart Disease in Type 1 Diabetes. Current Diabetes Reports 2015, 15: 30. PMID: 25821130, PMCID: PMC4376963, DOI: 10.1007/s11892-015-0598-1.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAnimalsAutoimmunityBiomarkersDiabetes Mellitus, Type 1Heart DiseasesHumansMagnetic Resonance ImagingMyocardiumConceptsCardiovascular diseaseHeart diseaseChronic myocardial inflammationPoor CVD outcomesUnderstanding of CVDType 1 diabetesCardiac autoimmunityMicrovascular complicationsCVD outcomesMyocardial inflammationClinical evidenceHeart syndromeExcess mortalityClinical studiesNovel biomarkersT1DTherapeutic implicationsTherapeutic targetType 2Type 1Same diseaseT2D.DiseaseDiagnostic assaysT1D.
2014
Autoantibodies and type 1 diabetes: are we still in the cave of an ancient myth?
Galderisi A. Autoantibodies and type 1 diabetes: are we still in the cave of an ancient myth? Diabetologia 2014, 57: 1502-1503. PMID: 24838679, DOI: 10.1007/s00125-014-3261-5.Commentaries, Editorials and Letters