Fox D Steven, Ware Julia, Boughton Charlotte K, Allen Janet M, Wilinska Malgorzata E, Tauschmann Martin, Denvir Louise, Thankamony Ajay, Campbell Fiona, Wadwa R Paul, Buckingham Bruce A, Davis Nikki, DiMeglio Linda A, Mauras Nelly, Besser Rachel E J, Ghatak Atrayee, Weinzimer Stuart A, Kanapka Lauren, Kollman Craig, Sibayan Judy, Beck Roy W, Hood Korey K, Hovorka Roman
Department of Pharmaceutical and Health Economics, Mann School of Pharmacy, University of Southern California, Los Angeles, CA, USA.
Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
J Diabetes Sci Technol. 2024 Mar 17:19322968241231950. doi: 10.1177/19322968241231950.
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).
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.
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).
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).
背景/目的：本研究的主要目的是评估剑桥混合闭环自动胰岛素给药（AID）算法相对于1型糖尿病（T1D）儿童及青少年常规治疗的增量成本效益（ICER）。
这项多中心、双边、平行对照试验将133名使用胰岛素泵的6至18岁参与者随机分为AID组（n = 65）或常规治疗组（n = 68），为期6个月。分析了试验期间及终生的成本效益。分析重点关注接受更可靠的CamAPS FX硬件迭代的治疗亚组（n = 21）及其同期对照组（n = 24）。通过更新后的谢菲尔德T1D政策模型模拟终生并发症和成本。
在试验期间，两组的健康相关生活质量无显著差异且在统计学上无变化，低血糖、严重低血糖和糖尿病酮症酸中毒（DKA）事件发生率在统计学上相似。治疗组的总医疗保健利用率更高。总体治疗组和CamAPS FX亚组的糖化血红蛋白均有所改善（分别为-0.32%，95%CI：-0.59至-0.04；P = 0.02，以及-1.05%，95%CI：-1.43至-0.67；P < 0.001）。模型预测CamAPS FX亚组的预期寿命增加5.36年，贴现质量调整生命年（QALY）分别为1.16（英国关税）和1.52（美国关税）。该亚组的估计ICER为19324英镑/QALY（英国）和-3917美元/QALY（美国）。对于已经使用持续葡萄糖监测仪（CGM）的亚组患者，ICER分别为10096英镑/QALY（英国）和-33616美元/QALY（美国）。概率敏感性分析得出的平均ICER为19342英镑/QALY（95%CI：15903英镑/QALY至22929英镑/QALY）（英国）和-28283美元/QALY（95%CI：-59607美元/QALY至1858美元/QALY）（美国）。
对于接受胰岛素泵治疗的T1D儿童及青少年，使用剑桥算法的AID在英国低于20000英镑/QALY的阈值时似乎具有成本效益，在美国则可节省成本。
