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.

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

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).

Déclaration de conflit d'intérêts

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MT reports receiving speaking and advisory fees from Eli Lilly, Novo Nordisk, Medtronic, and Abbott. RPW reports receiving grant support from MannKind, and Novo Nordisk, grant support and lecture fees from Dexcom, grant support, and advisory board fees from Eli Lilly, and grant support, travel support, and lecture fees from Tandem Diabetes Care. BAB reports receiving grant support, donated supplies, and advisory board fees from ConvaTec, grant support from Dexcom, grant support and honoraria from Insulet, grant support and advisory board fees from Medtronic MiniMed, and grant support from Tandem Diabetes Care. LADM reports grants from Medtronic. NM reports receiving grant support for devices from Medtronic. REJB reports receiving speaking honoraria from Eli Lilly and Springer Healthcare. SAW reports receiving consulting fees from Eli Lilly, Sanofi US Services, and Zealand, speaker honoraria from Dexcom, Insulet, Medtronic, and Tandem Diabetes Care, and grant support to his institution from Abbott and Medtronic. LK reports receiving grant support from Tandem Diabetes Care. CK reports receiving grant support from Tandem Diabetes Care. RWB reports receiving grant support and donated supplies from Abbott Diabetes Care, Ascensia Diabetes Care US, Beta Bionics, and Roche Diabetes Care, grant support, donated supplies, and consulting fees from Dexcom, Novo Nordisk, and Tandem Diabetes Care, grant support and consulting fees from Bigfoot Biomedical, and consulting fees from Eli Lilly and Insulet. RH reports receiving speaker honoraria from Eli Lilly, Dexcom and Novo Nordisk, receiving license fees from B. Braun and Medtronic; patents related to closed-loop, and being director at CamDiab. MEW reports patents related to closed-loop and being a consultant at CamDiab. JW reports receiving speaker honoraria from Ypsomed and Novo Nordisk. KKH reports receiving consulting fees from Cecelia Health and Havas Health. CKB reports receiving consultancy fees from CamDiab and speaker honoraria from Ypsomed, JMA, AT, JS, LD, FC, ND, AG, and DSF declare no competing financial interests exist.