214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial
Year: 2021
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BackgroundClosed-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 Cambridge hybrid closed-loop algorithm with usual care over six months in this population. MethodsIn 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.We randomly assigned participants to closed-loop insulin delivery or to usual care (control) for six months.The Cambridge closed-loop algorithm running on a smartphone was used with either (i) modified Medtronic 640G pump, Medtronic Guardian 3 sensor, and Medtronic prototype phone enclosure (FlorenceM configuration), or (ii) Sooil Dana RS pump and Dexcom G6 sensor (CamAPS FX configuration).Primary endpoint was change in HbA1c at six months combining data from both configurations.Analysis was by intention-to-treat.Trial registration ClinicalTrials.gov,NCT02925299. FindingsWe randomised 133 participants (mean±SD baseline HbA1c 8•2±0•7% vs 8•3±0•7%), 65 to closed-loop and 68 to control.At six months, HbA1c was 0•32% lower with closed-loop compared to control (95%CI 0•04 to 0•59; p=0•023).Closed-loop usage was low with FlorenceM due to failing phone enclosures (40% [26, 53]; median [IQR]), but consistently high with CamAPS FX (93% [88, 96]).In post-hoc analysis, HbA1c in the CamAPS FX closed-loop cohort (closed-loop n=21, control n=25) was 1•05% lower (95%CI 0•67 to 1•43; p<0•0001) and time in target range 3•9-10•0mmol/L 15•0 percentage points higher (95%CI 8•0 to 22•1; p=0•0001) in the closed-loop group compared to control, without increasing hypoglycaemia .Severe hypoglycaemia and DKA events were similar between closed-loop and control. InterpretationThe Cambridge hybrid closed-loop algorithm is safe and improves glycaemic control in children and adolescents with type 1 diabetes.Efficacy requires high usage of closed-loop as demonstrated with CamAPS FX.
Source: Diabetes
DOI: 10.2337/db21-214-or
Authors: JULIA FUCHS, CHARLOTTE K. BOUGHTON, JANET M. ALLEN, MALGORZATA E. WILINSKA, MARTIN TAUSCHMANN, LOUISE DENVIR, AJAY THANKAMONY, FIONA CAMPBELL, R. PAUL WADWA, BRUCE A. BUCKINGHAM, NIKKI DAVIS, LINDA DIMEGLIO, NELLY MAURAS, RACHEL BESSER, ATRAYEE GHATAK, STUART A. WEINZIMER, KOREY K. HOOD, D. STEVEN FOX, LAUREN KANAPKA, CRAIG KOLLMAN, JUDY SIBAYAN, ROY BECK, ROMAN HOVORKA
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G2018687014, G5246447471
OpenAlex ID: W3174968778