2022
A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes
Reiss AL, Jo B, Arbelaez AM, Tsalikian E, Buckingham B, Weinzimer SA, Fox LA, Cato A, White NH, Tansey M, Aye T, Tamborlane W, Englert K, Lum J, Mazaika P, Foland-Ross L, Marzelli M, Mauras N. A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes. Nature Communications 2022, 13: 4940. PMID: 36042217, PMCID: PMC9427757, DOI: 10.1038/s41467-022-32289-x.Peer-Reviewed Original ResearchConceptsHybrid closed-loop insulin delivery systemStandard care groupType 1 diabetesClosed-loop insulin delivery systemWhite matter volumeCare groupPrimary outcomeInsulin delivery systemsMatter volumeFractional anisotropyCognitive AssessmentRigorous glucose controlDiagnosis of T1DClosed-loop groupBetter diabetes controlDiabetes care groupsConcept pilot studyYears of ageAcademic medical centerFunctional brain activityCortical surface areaMonths study durationRandomized participantsDiabetes controlGlucose controlCambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial
Ware J, Boughton CK, Allen JM, Wilinska ME, Tauschmann M, Denvir L, Thankamony A, Campbell FM, Wadwa RP, Buckingham BA, Davis N, DiMeglio LA, Mauras N, Besser REJ, Ghatak A, Weinzimer SA, Hood KK, Fox DS, Kanapka L, Kollman C, Sibayan J, Beck RW, Hovorka R, Consortium D, Hovorka R, Acerini C, Thankamony A, Allen J, Boughton C, Dovc K, Dunger D, Ware J, Musolino G, Tauschmann M, Wilinska M, Hayes J, Hartnell S, Slegtenhorst S, Ruan Y, Haydock M, Mangat J, Denvir L, Kanthagnany S, Law J, Randell T, Sachdev P, Saxton M, Coupe A, Stafford S, Ball A, Keeton R, Cresswell R, Crate L, Cripps H, Fazackerley H, Looby L, Navarra H, Saddington C, Smith V, Verhoeven V, Bratt S, Khan N, Moyes L, Sandhu K, West C, Wadwa R, Alonso G, Forlenza G, Slover R, Towers L, Berget C, Coakley A, Escobar E, Jost E, Lange S, Messer L, Thivener K, Campbell F, Yong J, Metcalfe E, Allen M, Ambler S, Waheed S, Exall J, Tulip J, Buckingham B, Ekhlaspour L, Maahs D, Norlander L, Jacobson T, Twon M, Weir C, Leverenz B, Keller J, Davis N, Kumaran A, Trevelyan N, Dewar H, Price G, Crouch G, Ensom R, Haskell L, Lueddeke L, Mauras N, Benson M, Bird K, Englert K, Permuy J, Ponthieux K, Marrero-Hernandez J, DiMeglio L, Ismail H, Jolivette H, Sanchez J, Woerner S, Kirchner M, Mullen M, Tebbe M, Besser R, Basu S, London R, Makaya T, Ryan F, Megson C, Bowen-Morris J, Haest J, Law R, Stamford I, Ghatak A, Deakin M, Phelan K, Thornborough K, Shakeshaft J, Weinzimer S, Cengiz E, Sherr J, Van Name M, Weyman K, Carria L, Steffen A, Zgorski M, Sibayan J, Beck R, Borgman S, Davis J, Rusnak J, Hellman A, Cheng P, Kanapka L, Kollman C, McCarthy C, Chalasani S, Hood K, Hanes S, Viana J, Lanning M, Fox D, Arreaza-Rubin G, Eggerman T, Green N, Janicek R, Gabrielson D, Belle S, Castle J, Green J, Legault L, Willi S, Wysham C. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial. The Lancet Digital Health 2022, 4: e245-e255. PMID: 35272971, DOI: 10.1016/s2589-7500(22)00020-6.Peer-Reviewed Original ResearchConceptsClosed-loop groupInsulin pump therapyType 1 diabetesControl groupBaseline HbAUsual carePump therapyClosed-loop insulin deliverySuboptimal glucose controlPediatric diabetes centersKey inclusion criteriaClosed-loop insulin delivery systemPrimary endpointBlock randomisationDiabetes CenterGlucose controlInsulin delivery systemsInclusion criteriaPrimary analysisTherapyInsulin deliveryMonthsG pumpHbADiabetes
2020
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Cherñavvsky D, Wadwa RP. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. New England Journal Of Medicine 2020, 383: 836-845. PMID: 32846062, PMCID: PMC7920146, DOI: 10.1056/nejmoa2004736.Peer-Reviewed Original ResearchConceptsType 1 diabetesSensor-augmented insulin pumpClosed-loop groupGlucose levelsMedian percentageTarget rangeInsulin pumpInsulin deliveryParallel-group trialYears of ageContinuous glucose monitoringDiabetic ketoacidosisPrimary outcomeSevere hypoglycemiaHemoglobin levelsRandomized trialsGlycemic outcomesPercentage of timeChildren 6Control groupType 1DiabetesMean percentageGlucose monitoringTrials