1. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial
- Author
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Julia Ware, Charlotte K Boughton, Janet M Allen, Malgorzata E Wilinska, Martin Tauschmann, Louise Denvir, Ajay Thankamony, Fiona M Campbell, R Paul Wadwa, Bruce A Buckingham, Nikki Davis, Linda A DiMeglio, Nelly Mauras, Rachel E J Besser, Atrayee Ghatak, Stuart A Weinzimer, Korey K Hood, D Steven Fox, Lauren Kanapka, Craig Kollman, Judy Sibayan, Roy W Beck, Roman Hovorka, R Hovorka, C L Acerini, A Thankamony, J M Allen, C K Boughton, K Dovc, D B Dunger, J Ware, G Musolino, M Tauschmann, M E Wilinska, J F Hayes, S Hartnell, S Slegtenhorst, Y Ruan, M Haydock, J Mangat, L Denvir, SK Kanthagnany, J Law, T Randell, P Sachdev, M Saxton, A Coupe, S Stafford, A Ball, R Keeton, R Cresswell, L Crate, H Cripps, H Fazackerley, L Looby, H Navarra, C Saddington, V Smith, V Verhoeven, S Bratt, N Khan, L Moyes, K Sandhu, C West, R P Wadwa, G Alonso, G Forlenza, R Slover, L Towers, C Berget, A Coakley, E Escobar, E Jost, S Lange, L Messer, K Thivener, F M Campbell, J Yong, E Metcalfe, M Allen, S Ambler, S Waheed, J Exall, J Tulip, B A Buckingham, L Ekhlaspour, D Maahs, L Norlander, T Jacobson, M Twon, C Weir, B Leverenz, J Keller, N Davis, A Kumaran, N Trevelyan, H Dewar, G Price, G Crouch, R Ensom, L Haskell, LM Lueddeke, N Mauras, M Benson, K Bird, K Englert, J Permuy, K Ponthieux, J Marrero-Hernandez, L A DiMeglio, H Ismail, H Jolivette, J Sanchez, S Woerner, M Kirchner, M Mullen, M Tebbe, R EJ Besser, S Basu, R London, T Makaya, F Ryan, C Megson, J Bowen-Morris, J Haest, R Law, I Stamford, A Ghatak, M Deakin, K Phelan, K Thornborough, J Shakeshaft, S A Weinzimer, E Cengiz, J L Sherr, M Van Name, K Weyman, L Carria, A Steffen, M Zgorski, J Sibayan, R W Beck, S Borgman, J Davis, J Rusnak, A Hellman, P Cheng, L Kanapka, C Kollman, C McCarthy, S Chalasani, K K Hood, S Hanes, J Viana, M Lanning, D S Fox, G Arreaza-Rubin, T Eggerman, N Green, R Janicek, D Gabrielson, S H Belle, J Castle, J Green, L Legault, S M Willi, and C Wysham
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Blood Glucose ,Male ,Adolescent ,Medicine (miscellaneous) ,Health Informatics ,Diabetic Ketoacidosis ,Diabetes Mellitus, Type 1 ,Insulin Infusion Systems ,Health Information Management ,Humans ,Hypoglycemic Agents ,Insulin ,Decision Sciences (miscellaneous) ,Female ,Child ,Algorithms - Abstract
Closed-loop insulin delivery systems have the potential to address suboptimal glucose control in children and adolescents with type 1 diabetes. We compared safety and efficacy of the Cambridge hybrid closed-loop algorithm with usual care over 6 months in this population.In a multicentre, multinational, parallel randomised controlled trial, participants aged 6-18 years using insulin pump therapy were recruited at seven UK and five US paediatric diabetes centres. Key inclusion criteria were diagnosis of type 1 diabetes for at least 12 months, insulin pump therapy for at least 3 months, and screening HbAOf 147 people initially screened, 133 participants (mean age 13·0 years [SD 2·8]; 57% female, 43% male) were randomly assigned to either the closed-loop group (n=65) or the control group (n=68). Mean baseline HbAThe Cambridge hybrid closed-loop algorithm had an acceptable safety profile, and improved glycaemic control in children and adolescents with type 1 diabetes. To ensure optimal efficacy of the closed-loop system, usage needs to be consistently high, as demonstrated with CamAPS FX.National Institute of Diabetes and Digestive and Kidney Diseases.
- Published
- 2021