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在诊室内评估 1 型糖尿病儿童使用 MiniMed 670G 系统的“低血糖暂停”功能。

In-Clinic Evaluation of the MiniMed 670G System "Suspend Before Low" Feature in Children with Type 1 Diabetes.

机构信息

1 Division of Pediatric Endocrinology, University of Michigan Medical School , Ann Arbor, Michigan.

2 USF Diabetes Center, Morsani College of Medicine, University of South Florida , Tampa, Florida.

出版信息

Diabetes Technol Ther. 2018 Nov;20(11):731-737. doi: 10.1089/dia.2018.0209. Epub 2018 Oct 6.

Abstract

BACKGROUND

The Medtronic predictive low-glucose management (PLGM) algorithm automatically stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low-glucose value within the next 30 min, and resumes delivery after hypoglycemia recovery. The present study evaluated the PLGM algorithm performance of the MiniMed™ 670G system SmartGuard™ "suspend before low" feature in children aged 7-13 years with type 1 diabetes (T1D).

METHOD

Participants (N = 105, mean ± standard deviation of 10.8 ± 1.8 years) underwent an overnight in-clinic evaluation of the "suspend before low" feature with a preset low limit of 65 mg/dL. After exercise, frequent sample testing (FST) was conducted every 5 min if values were <70 mg/dL; every 15 min if 70-80 mg/dL; and every 30 min if >80 mg/dL. First-day performance of the Guardian™ Sensor 3 glucose sensor and continuous glucose monitoring system was also evaluated.

RESULTS

Activation of the "suspend before low" feature occurred in 79 of the 105 participants, 79.7% (63/79) did not result in SG falling below 65 mg/dL. Mean glucose at activation was 102 ± 19 mg/dL and the initial insulin suspension duration was 87.5 ± 32.7 min. Four hours after insulin resumption, mean reference glucose was 130 ± 42 mg/dL. Mean absolute relative difference between the FST reference glucose and SG values on the first day of sensor wear was 11.4%. For the 26 participants in whom the "suspend before low" feature did not activate, none involved a reference glucose value ≤65 mg/dL, suggesting that the PLGM algorithm performed as intended.

CONCLUSION

In children aged 7-13 years with T1D, the "suspend before low" feature of the MiniMed 670G system demonstrated a hypoglycemia prevention rate of nearly 80% after exercise and did not involve rebound hyperglycemia. There were no events of severe hypoglycemia during the evaluation.

摘要

背景

美敦力的预测性低血糖管理(PLGM)算法会在传感器血糖(SG)预测在接下来 30 分钟内达到或低于预设低血糖值时自动停止胰岛素输送,并在低血糖恢复后恢复输送。本研究评估了 MiniMed™ 670G 系统 SmartGuard™“低血糖前暂停”功能在 7-13 岁 1 型糖尿病(T1D)儿童中的 PLGM 算法性能。

方法

参与者(N=105,平均年龄为 10.8±1.8 岁)接受了一次过夜门诊评估,设定低血糖下限为 65mg/dL。运动后,如果值<70mg/dL,则每 5 分钟进行一次频繁样本测试(FST);如果值为 70-80mg/dL,则每 15 分钟进行一次 FST;如果值>80mg/dL,则每 30 分钟进行一次 FST。还评估了 Guardian™传感器 3 血糖传感器和连续血糖监测系统的第一天性能。

结果

在 105 名参与者中,有 79 名(79.7%,63/79)激活了“低血糖前暂停”功能,SG 没有降至 65mg/dL 以下。激活时的平均血糖为 102±19mg/dL,初始胰岛素暂停时间为 87.5±32.7 分钟。胰岛素恢复后 4 小时,平均参考血糖为 130±42mg/dL。第一天佩戴传感器时,FST 参考血糖和 SG 值之间的平均绝对相对差异为 11.4%。对于 26 名未激活“低血糖前暂停”功能的参与者,没有参考血糖值≤65mg/dL,这表明 PLGM 算法按预期运行。

结论

在 7-13 岁的 T1D 儿童中,MiniMed 670G 系统的“低血糖前暂停”功能在运动后表现出近 80%的低血糖预防率,且不会出现反弹性高血糖。评估期间没有发生严重低血糖事件。

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