1 Department of Pediatrics, University Hospital Motol and 2nd Faculty of Medicine, Charles University in Prague , Prague, Czech Republic .
2 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University in Prague , Prague, Czech Republic .
Diabetes Technol Ther. 2018 Nov;20(11):744-750. doi: 10.1089/dia.2018.0214. Epub 2018 Oct 4.
Officially licensed hybrid closed-loop systems are not currently available worldwide; therefore, open-source systems have become increasingly popular. Our aim was to assess the safety, feasibility, and efficacy of an open-source hybrid closed-loop system (AndroidAPS) versus SmartGuard technology for day-and-night glucose control in children under extreme sports conditions.
Twenty-two children (16 girls, 6-15 years of age, median HbA1c 56 ± 9 mmol/mol) were enrolled in this pivotal winter sports camp study. The participants were divided into two groups using either the AndroidAPS or SmartGuard technology. Physical exertion was represented by all-day alpine skiing. The primary endpoints were mean glucose level, time below the threshold of 3.9 mmol/L, and time within the target range of 3.9 to 10 mmol/L.
The children using the AndroidAPS had significantly lower mean glycemia levels (7.2 ± 2.7 vs. 7.7 ± 2.8 mmol/L; 129.6 ± 49 vs. 138.6 ± 50 mg/dL, P < 0.042) than the children using the SmartGuard. The proportion of time below the target (median 5.0% ± 2.5% vs. 3.0% ± 2.3%, P = 0.6) and in the target zone (63% ± 9.5% vs. 63% ± 18%, P = 0.5) did not significantly differ. The AndroidAPS group experienced more frequent malfunctions of the cannula set (median 0.8 ± 0.4 vs. 0.2 ± 0.4, P = 0.02), which could have affected the results. No significant difference was found in the amount of carbohydrates consumed for the prevention and treatment of hypoglycemia [median 40 ± 23 vs. 25 ± 29 g/(patient ·3 days)]. No episodes of severe hypoglycemia or other serious adverse events were noted.
This pilot study showed that the AndroidAPS system was a safe and feasible alternative to the SmartGuard Technology.
目前全球尚未有官方许可的混合闭环系统，因此开源系统变得越来越受欢迎。我们的目的是评估开源混合闭环系统（AndroidAPS）与 SmartGuard 技术在儿童极端运动条件下的昼夜血糖控制中的安全性、可行性和疗效。
本研究纳入了 22 名儿童（16 名女孩，年龄 6-15 岁，中位 HbA1c 为 56±9mmol/mol），他们参加了一个冬季运动营研究。参与者被分为 AndroidAPS 组和 SmartGuard 组。全天的高山滑雪代表了体力活动。主要终点是平均血糖水平、低于 3.9mmol/L 的时间和处于 3.9 至 10mmol/L 目标范围内的时间。
使用 AndroidAPS 的儿童的平均血糖水平明显更低（7.2±2.7 比 7.7±2.8mmol/L；129.6±49 比 138.6±50mg/dL，P<0.042），使用 SmartGuard 的儿童则更高。低于目标的时间比例（中位数 5.0%±2.5%比 3.0%±2.3%，P=0.6）和在目标范围内的时间比例（63%±9.5%比 63%±18%，P=0.5）无显著差异。AndroidAPS 组的导管组更频繁出现故障（中位数 0.8±0.4 比 0.2±0.4，P=0.02），这可能影响了结果。为预防和治疗低血糖而消耗的碳水化合物量（中位数 40±23 比 25±29g/（患者·3 天））无显著差异。未出现严重低血糖或其他严重不良事件。
这项初步研究表明，AndroidAPS 系统是 SmartGuard 技术的一种安全且可行的替代方案。
