Cost-Effectiveness of Closed-Loop Automated Insulin Delivery Using the Cambridge Hybrid Algorithm in Children and Adolescents with Type 1 Diabetes: Results from a Multicenter 6-Month Randomized Trial.
D Steven Fox, Julia Ware, 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 A DiMeglio, Nelly Mauras, Rachel E J Besser, Atrayee Ghatak, Stuart A Weinzimer, Lauren Kanapka, Craig Kollman, Judy Sibayan, Roy W Beck, Korey K Hood, Roman Hovorka
Author Information
D Steven Fox: Department of Pharmaceutical and Health Economics, Mann School of Pharmacy, University of Southern California, Los Angeles, CA, USA. ORCID
Julia Ware: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK. ORCID
Charlotte K Boughton: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK. ORCID
Janet M Allen: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Malgorzata E Wilinska: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Martin Tauschmann: Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Louise Denvir: Department of Paediatric Diabetes and Endocrinology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Ajay Thankamony: Department of Paediatrics, University of Cambridge, Cambridge, UK.
Fiona Campbell: Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.
R Paul Wadwa: Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. ORCID
Bruce A Buckingham: Stanford University School of Medicine, Stanford Diabetes Research Center, Stanford, CA, USA. ORCID
Nikki Davis: Department of Paediatric Endocrinology and Diabetes, Southampton Children's Hospital, Southampton General Hospital, Southampton, UK.
Linda A DiMeglio: Division of Pediatric Endocrinology and Diabetology, Department of Pediatrics, Wells Center for Pediatric Research, Indiana University School of Medicine, Indianapolis, IN, USA.
Nelly Mauras: Nemours Children's Health, Jacksonville, FL, USA.
Rachel E J Besser: Oxford University Hospitals NHS Foundation Trust, NIHR Oxford Biomedical Research Centre, Oxford, UK. ORCID
Stuart A Weinzimer: Department of Pediatrics, Yale University, New Haven, CT, USA.
Lauren Kanapka: The Jaeb Center for Health Research, Tampa, FL, USA. ORCID
Craig Kollman: The Jaeb Center for Health Research, Tampa, FL, USA.
Judy Sibayan: The Jaeb Center for Health Research, Tampa, FL, USA.
Roy W Beck: The Jaeb Center for Health Research, Tampa, FL, USA.
Korey K Hood: Stanford University School of Medicine, Stanford Diabetes Research Center, Stanford, CA, USA. ORCID
Roman Hovorka: Department of Pharmaceutical and Health Economics, Mann School of Pharmacy, University of Southern California, Los Angeles, CA, USA. ORCID
BACKGROUND/OBJECTIVE: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D). METHODS: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed. Analysis focused on the treatment subgroup (n = 21) who received the much more reliable CamAPS FX hardware iteration and their contemporaneous control group (n = 24). Lifetime complications and costs were simulated via an updated Sheffield T1D policy model. RESULTS: Within-trial, both groups had indistinguishable and statistically unchanged health-related quality of life, and statistically similar hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis (DKA) event rates. Total health care utilization was higher in the treatment group. Both the overall treatment group and CamAPS FX subgroup exhibited improved HbA (-0.32%, 95% CI: -0.59 to -0.04; = .02, and -1.05%, 95% CI: -1.43 to -0.67; < .001, respectively). Modeling projected increased expected lifespan of 5.36 years and discounted quality-adjusted life years (QALYs) of 1.16 (U.K. tariffs) and 1.52 (U.S. tariffs) in the CamAPS FX subgroup. Estimated ICERs for the subgroup were £19 324/QALY (United Kingdom) and -$3917/QALY (United States). For subgroup patients already using continuous glucose monitors (CGM), ICERs were £10 096/QALY (United Kingdom) and -$33 616/QALY (United States). Probabilistic sensitivity analysis generated mean ICERs of £19 342/QALY (95% CI: £15 903/QALY to £22 929/QALY) (United Kingdom) and -$28 283/QALY (95% CI: -$59 607/QALY to $1858/QALY) (United States). CONCLUSIONS: For children and adolescents with T1D on insulin pump therapy, AID using the Cambridge algorithm appears cost-effective below a £20 000/QALY threshold (United Kingdom) and cost saving (United States).
