1 Children's Hospital on the Bult , Hannover, Germany .
Diabetes Technol Ther. 2014 Jun;16(6):338-47. doi: 10.1089/dia.2013.0327. Epub 2014 Jan 21.
Predictive low glucose management (PLGM) may help prevent hypoglycemia by stopping insulin pump delivery based on predicted sensor glucose values.
Hypoglycemic challenges were simulated using the Food and Drug Administration-accepted glucose simulator with 100 virtual patients. PLGM was then tested with a system composed of a Paradigm(®) insulin pump (Medtronic, Northridge, CA), an Enlite™ glucose sensor (Medtronic), and a BlackBerry(®) (Waterloo, ON, Canada)-based controller. Subjects (n=22) on continuous subcutaneous insulin infusion (five females, 17 males; median [range] age, 15 [range, 14-20] years; median [range] diabetes duration, 7 [2-14] years; median [range] glycated hemoglobin, 8.0% [6.7-10.4%]) exercised until the PLGM system suspended insulin delivery or until the reference blood glucose value (HemoCue(®); HemoCue GmbH, Großostheim, Germany) reached the predictive suspension threshold setting.
PLGM reduced hypoglycemia (<70 mg/dL) in silico by 26.7% compared with no insulin suspension, as opposed to a 5.3% reduction in hypoglycemia with use of low glucose suspend (LGS). The median duration of hypoglycemia (time spent <70 mg/dL) with PLGM was significantly less than with LGS (58 min vs. 101 min, respectively; P<0.001). In the clinical trial the hypoglycemic threshold during exercise was reached in 73% of the patients, and hypoglycemia was prevented in 80% of the successful experiments. The mean (±SD) sensor glucose at predictive suspension was 92±7 mg/dL, resulting in a postsuspension nadir (by HemoCue) of 77±22 mg/dL. The suspension lasted for 90±35 (range, 30-120) min, resulting in a sensor glucose level at insulin resumption of 97±19 mg/dL.
In silico modeling and early feasibility data demonstrate that PLGM may further reduce the severity of hypoglycemia beyond that already established for algorithms that use a threshold-based suspension.
预测性低血糖管理（PLGM）可通过根据预测的传感器血糖值停止胰岛素泵输送来帮助预防低血糖。
使用食品和药物管理局认可的血糖模拟器和 100 个虚拟患者模拟了低血糖挑战。然后，使用由 Paradigm®胰岛素泵（美敦力，北岭，加利福尼亚州）、Enlite™葡萄糖传感器（美敦力）和基于 BlackBerry®（滑铁卢，安大略省，加拿大）的控制器组成的系统对 PLGM 进行了测试。接受连续皮下胰岛素输注的受试者（n=22；5 名女性，17 名男性；中位数[范围]年龄，15[范围，14-20]岁；中位数[范围]糖尿病病程，7[2-14]年；中位数[范围]糖化血红蛋白，8.0%[6.7-10.4%]）运动至 PLGM 系统暂停胰岛素输送或参考血糖值（HemoCue®；HemoCue GmbH，格罗斯奥斯特海姆，德国）达到预测暂停阈值设定。
与无胰岛素暂停相比，PLGM 在计算机模拟中使低血糖（<70mg/dL）降低了 26.7%，而使用低血糖暂停（LGS）则使低血糖降低了 5.3%。PLGM 时低血糖（时间<70mg/dL）的中位数持续时间明显短于 LGS（分别为 58 分钟和 101 分钟；P<0.001）。在临床试验中，73%的患者在运动期间达到了低血糖阈值，80%的成功试验预防了低血糖。预测暂停时传感器血糖的平均值（±SD）为 92±7mg/dL，导致暂停后（通过 HemoCue）的最低点为 77±22mg/dL。暂停持续了 90±35（范围，30-120）分钟，导致胰岛素恢复时传感器血糖水平为 97±19mg/dL。
计算机模拟和早期可行性数据表明，PLGM 可能会进一步降低低血糖的严重程度，超过已经建立的基于阈值的暂停算法。
