Ly Trang T, Breton Marc D, Keith-Hynes Patrick, De Salvo Daniel, Clinton Paula, Benassi Kari, Mize Benton, Chernavvsky Daniel, Place Jéróme, Wilson Darrell M, Kovatchev Boris P, Buckingham Bruce A
Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CASchool of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia.
Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.
To determine the safety and efficacy of an automated unified safety system (USS) in providing overnight closed-loop (OCL) control in children and adolescents with type 1 diabetes attending diabetes summer camps.
The Diabetes Assistant (DIAS) USS used the Dexcom G4 Platinum glucose sensor (Dexcom) and t:slim insulin pump (Tandem Diabetes Care). An initial inpatient study was completed for 12 participants to evaluate safety. For the main camp study, 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy (control conditions) per night over the course of a 5- to 6-day diabetes camp.
Subjects completed 54 OCL nights and 52 control nights. On an intention-to-treat basis, with glucose data analyzed regardless of system status, the median percent time in range, from 70-150 mg/dL, was 62% (29, 87) for OCL nights versus 55% (25, 80) for sensor-augmented pump therapy (P = 0.233). A per-protocol analysis allowed for assessment of algorithm performance. The median percent time in range, from 70-150 mg/dL, was 73% (50, 89) for OCL nights (n = 41) versus 52% (24, 83) for control conditions (n = 39) (P = 0.037). There was less time spent in the hypoglycemic range <50, <60, and <70 mg/dL during OCL compared with the control period (P = 0.019, P = 0.009, and P = 0.023, respectively).
The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting.
确定自动化统一安全系统（USS）在为参加糖尿病夏令营的1型糖尿病儿童和青少年提供夜间闭环（OCL）控制方面的安全性和有效性。
糖尿病助手（DIAS）USS使用德康G4铂血糖传感器（德康）和t:slim胰岛素泵（串联糖尿病护理公司）。对12名参与者完成了一项初步住院研究以评估安全性。在为期5至6天的糖尿病夏令营期间，每晚将20名1型糖尿病参与者随机分为OCL组或传感器增强治疗组（对照条件）。
受试者完成了54个OCL夜间和52个对照夜间。在意向性分析的基础上，无论系统状态如何分析血糖数据，OCL夜间70 - 150mg/dL范围内的中位时间百分比为62%（29，87），而传感器增强泵治疗组为55%（25，80）（P = 0.233）。一项符合方案分析允许评估算法性能。OCL夜间（n = 41）70 - 150mg/dL范围内的中位时间百分比为73%（50，89），而对照条件下（n = 39）为52%（24，83）（P = 0.037）。与对照期相比，OCL期间处于低血糖范围<50、<60和<70mg/dL的时间更少（分别为P = 0.019、P = 0.009和P = 0.023）。
在糖尿病夏令营环境中，DIAS USS算法可有效改善1型糖尿病儿童和青少年夜间处于目标范围内的时间，并减少夜间低血糖情况。
