Children's Hospital "Auf der Bult," Diabetes-Center for Children and Adolescents, Hannover, Germany.
Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.
Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.
Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes.
This was a prospective, multicentre, crossover, controlled study (clinicaltrials.gov NCT01238406). All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System. In the intervention arm only, the amount of carbohydrate was entered into the bolus calculator; the rest of insulin delivery was automated and wireless via a tablet computer. The primary endpoint was percentage of glucose values between 70 and 180 mg/dL.
The ITT population comprised 48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age, 16.1years [13.2-18.5]; diabetes duration, 9.4 years [5.0-12.7]; pump use, 5.4 years [3.1-9.4]; HbA1c, 7.6% [7.0-8.1]. A significant increase in the percentage of time within target range (70-180 mg/dL) (66.6% vs 59.9%, P = 0.002) was observed with the closed-loop system vs control weekends with unchanged percentage of time below 70 mg/dL (2.3% vs 1.5%, P = 0.369). Mean weekend glucose level per participant was significantly lower (153 [142-175] vs 164 [150-186] mg/dL, P = 0.003). No safety signals were observed.
The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use. The absence of remote monitoring did not lead to safety signals in adapting basal rates nor in administration of automated bolus corrections.
先前的 DREAM 研究证明了经 CE 标记的 MD-Logic 闭环系统（DreaMed GlucoSitter）在不同环境下用于夜间血糖控制的安全性和有效性。本研究旨在评估该系统在周末家庭环境中进行为期 60 小时的日夜间使用情况，与 1 型糖尿病患者的传感器增强型泵（SAP）治疗进行比较。
这是一项前瞻性、多中心、交叉、对照研究（clinicaltrials.gov NCT01238406）。所有参与者均以随机顺序连接，接受一个周末的 SAP 治疗或 MD-Logic 系统治疗。仅在干预组中，将碳水化合物的量输入到推注计算器中；其余胰岛素输送则通过平板电脑自动无线完成。主要终点是血糖值在 70 至 180mg/dL 之间的百分比。
意向治疗人群包括 48 名（19 名男性，29 名女性）有经验使用传感器的青少年和成年人：（中位数，[IQR]）：年龄 16.1 岁[13.2-18.5]；糖尿病病程 9.4 年[5.0-12.7]；泵使用 5.4 年[3.1-9.4]；HbA1c 7.6%[7.0-8.1]。与对照周末相比，闭环系统治疗可显著增加目标范围内（70-180mg/dL）的时间百分比（66.6% vs 59.9%，P = 0.002），而血糖值低于 70mg/dL 的时间百分比保持不变（2.3% vs 1.5%，P = 0.369）。每位参与者的周末平均血糖水平显著降低（153[142-175]vs 164[150-186]mg/dL，P = 0.003）。未观察到安全信号。
与 SAP 治疗相比，MD-Logic 系统在日夜间使用时更加安全，并能更好地控制血糖。缺乏远程监测并未导致基础率调整或自动推注校正的安全性信号。
