Finan Daniel A, McCann Thomas W, Mackowiak Linda, Dassau Eyal, Patek Stephen D, Kovatchev Boris P, Doyle Francis J, Zisser Howard, Anhalt Henry, Venugopalan Ramakrishna
Animas Corporation, West Chester, PA, USA
Animas Corporation, West Chester, PA, USA.
J Diabetes Sci Technol. 2014 Jan;8(1):35-42. doi: 10.1177/1932296813511730. Epub 2014 Jan 1.
This feasibility study investigated the insulin-delivery characteristics of the Hypoglycemia-Hyperglycemia Minimizer (HHM) System-an automated insulin delivery device-in participants with type 1 diabetes.
Thirteen adults with type 1 diabetes were enrolled in this nonrandomized, uncontrolled, clinical-research-center-based feasibility study. The HHM System comprised a continuous subcutaneous insulin infusion pump, a continuous glucose monitor (CGM), and a model predictive control algorithm with a safety module, run on a laptop platform. Closed-loop control lasted approximately 20 hours, including an overnight period and two meals.
When attempting to minimize glucose excursions outside of a prespecified target zone, the predictive HHM System decreased insulin infusion rates below the participants' preset basal rates in advance of below-zone excursions (CGM < 90 mg/dl), and delivered 80.4% less insulin than basal during those excursions. Similarly, the HHM System increased infusion rates above basal during above-zone excursions (CGM > 140 mg/dl), delivering 39.9% more insulin than basal during those excursions. Based on YSI, participants spent a mean ± standard deviation (SD) of 0.2 ± 0.5% of the closed-loop control time at glucose levels < 70 mg/dl, including 0.3 ± 0.9% for the overnight period. The mean ± SD glucose based on YSI for all participants was 164.5 ± 23.5 mg/dl. There were nine instances of algorithm-recommended supplemental carbohydrate administrations, and there was no severe hypoglycemia or diabetic ketoacidosis.
Results of this study indicate that the current HHM System is a feasible foundation for development of a closed-loop insulin delivery device.
本可行性研究调查了低血糖-高血糖最小化器（HHM）系统（一种自动胰岛素输送装置）在1型糖尿病患者中的胰岛素输送特性。
13名1型糖尿病成年患者参与了这项基于临床研究中心的非随机、非对照可行性研究。HHM系统包括一个持续皮下胰岛素输注泵、一个连续血糖监测仪（CGM）以及在笔记本电脑平台上运行的带有安全模块的模型预测控制算法。闭环控制持续约20小时，包括一个夜间时段和两餐。
在试图将血糖波动最小化至预设目标范围之外时，预测性HHM系统在血糖低于目标范围（CGM<90mg/dl）之前就将胰岛素输注速率降至参与者预设的基础速率以下，且在这些时段内输送的胰岛素比基础量少80.4%。同样，HHM系统在血糖高于目标范围（CGM>140mg/dl）时将输注速率提高至基础速率以上，在这些时段内输送的胰岛素比基础量多39.9%。基于葡萄糖氧化酶法（YSI），参与者在闭环控制时间内血糖水平<70mg/dl的平均时间占比为0.2±0.5%，其中夜间时段为0.3±0.9%。所有参与者基于YSI的平均血糖为164.5±23.5mg/dl。算法推荐了9次补充碳水化合物给药，且未发生严重低血糖或糖尿病酮症酸中毒。
本研究结果表明，当前的HHM系统是开发闭环胰岛素输送装置的可行基础。
