Forlenza Gregory P, Deshpande Sunil, Ly Trang T, Howsmon Daniel P, Cameron Faye, Baysal Nihat, Mauritzen Eric, Marcal Tatiana, Towers Lindsey, Bequette B Wayne, Huyett Lauren M, Pinsker Jordan E, Gondhalekar Ravi, Doyle Francis J, Maahs David M, Buckingham Bruce A, Dassau Eyal
Barbara Davis Center, University of Colorado Denver, Denver, CO.
Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
Diabetes Care. 2017 Aug;40(8):1096-1102. doi: 10.2337/dc17-0500. Epub 2017 Jun 5.
As artificial pancreas (AP) becomes standard of care, consideration of extended use of insulin infusion sets (IIS) and continuous glucose monitors (CGMs) becomes vital. We conducted an outpatient randomized crossover study to test the safety and efficacy of a zone model predictive control (zone-MPC)-based AP system versus sensor augmented pump (SAP) therapy in which IIS and CGM failures were provoked via extended wear to 7 and 21 days, respectively.
A smartphone-based AP system was used by 19 adults (median age 23 years [IQR 10], mean 8.0 ± 1.7% HbA) over 2 weeks and compared with SAP therapy for 2 weeks in a crossover, unblinded outpatient study with remote monitoring in both study arms.
AP improved percent time 70-140 mg/dL (48.1 vs. 39.2%; = 0.016) and time 70-180 mg/dL (71.6 vs. 65.2%; = 0.008) and decreased median glucose (141 vs. 153 mg/dL; = 0.036) and glycemic variability (SD 52 vs. 55 mg/dL; = 0.044) while decreasing percent time <70 mg/dL (1.3 vs. 2.7%; = 0.001). AP also improved overnight control, as measured by mean glucose at 0600 h (140 vs. 158 mg/dL; = 0.02). IIS failures (1.26 ± 1.44 vs. 0.78 ± 0.78 events; = 0.13) and sensor failures (0.84 ± 0.6 vs. 1.1 ± 0.73 events; = 0.25) were similar between AP and SAP arms. Higher percent time in closed loop was associated with better glycemic outcomes.
Zone-MPC significantly and safely improved glycemic control in a home-use environment despite prolonged CGM and IIS wear. This project represents the first home-use AP study attempting to provoke and detect component failure while successfully maintaining safety and effective glucose control.
随着人工胰腺（AP）成为标准治疗方案，考虑延长胰岛素输注装置（IIS）和持续葡萄糖监测仪（CGM）的使用变得至关重要。我们进行了一项门诊随机交叉研究，以测试基于区域模型预测控制（zone-MPC）的AP系统与传感器增强泵（SAP）疗法的安全性和有效性，其中通过分别延长佩戴至7天和21天来引发IIS和CGM故障。
19名成年人（中位年龄23岁[四分位间距10]，平均糖化血红蛋白8.0±1.7%）使用基于智能手机的AP系统2周，并在一项交叉、非盲的门诊研究中与SAP疗法进行2周比较，两个研究组均进行远程监测。
AP改善了血糖在70 - 140 mg/dL的时间百分比（48.1%对39.2%；P = 0.016）和血糖在70 - 180 mg/dL的时间百分比（71.6%对65.2%；P = 0.008），降低了中位血糖水平（141 mg/dL对153 mg/dL；P = 0.036）和血糖变异性（标准差52 mg/dL对55 mg/dL；P = 0.044），同时降低了血糖<70 mg/dL的时间百分比（1.3%对2.7%；P = 0.001）。AP还改善了夜间血糖控制，以06:00时的平均血糖水平衡量（140 mg/dL对158 mg/dL；P = 0.02）。AP组和SAP组之间的IIS故障（1.26±1.44次对0.78±0.78次；P = 0.13）和传感器故障（0.84±0.6次对1.1±0.73次；P = 0.25）相似。闭环时间百分比越高，血糖控制效果越好。
尽管CGM和IIS延长佩戴，但zone-MPC在家庭使用环境中显著且安全地改善了血糖控制。该项目是首次尝试引发和检测组件故障同时成功维持安全有效的血糖控制的家庭使用AP研究。
