Meals are a major hurdle to glycemic control in type 1 diabetes (T1D). Our objective was to test a fully automated closed-loop control (CLC) system in the absence of announcement of carbohydrate ingestion among adolescents with T1D, who are known to commonly omit meal announcement.

Eighteen adolescents with T1D (age 15.6 ± 1.7 years; HbA_1c 7.4 ± 1.5%; 9 females/9 males) participated in a randomized crossover clinical trial comparing our legacy hybrid CLC system (Unified Safety System Virginia [USS]-Virginia) with a novel fully automated CLC system (RocketAP) during two 46-h supervised admissions (each with one announced and one unannounced dinner), following 2 weeks of data collection. Primary outcome was the percentage time-in-range 70–180 mg/dL (TIR) following the unannounced meal, with secondary outcomes related to additional continuous glucose monitoring-based metrics.

Both TIR and time-in-tight-range 70–140 mg/dL (TTR) were significantly higher using RocketAP than using USS-Virginia during the 6 h following the unannounced meal (83% [interquartile range 64–93] vs. 53% [40–71]; P = 0.004 and 49% [41–59] vs. 27% [22–36]; P = 0.002, respectively), primarily driven by reduced time-above-range (TAR >180 mg/dL: 17% [1.3–34] vs. 47% [28–60]), with no increase in time-below-range (TBR <70 mg/dL: 0% median for both). RocketAP also improved control following the announced meal (mean difference TBR: –0.7%, TIR: +7%, TTR: +6%), overall (TIR: +5%, TAR: –5%, TTR: +8%), and overnight (TIR: +7%, TTR: +19%, TAR: –5%). RocketAP delivered less insulin overall (78 ± 23 units vs. 85 ± 20 units, P = 0.01).

A new fully automated CLC system with automatic prandial dosing was proven to be safe and feasible and outperformed our legacy USS-Virginia in an adolescent population with and without meal announcement.

膳食是 1 型糖尿病 (T1D) 血糖控制的主要障碍。我们的目标是测试一个全自动闭环控制 (CLC) 系统，在 T1D 青少年中没有碳水化合物摄入的公告，他们通常会忽略进餐公告。

18 名 T1D 青少年（年龄 15.6 ± 1.7 岁；HbA _1c 7.4 ± 1.5%；9 名女性/9 名男性）参加了一项随机交叉临床试验，比较我们的传统混合 CLC 系统（统一安全系统弗吉尼亚 [USS]-弗吉尼亚）与在收集了 2 周的数据后，在两次 46 小时有监督的入院（每个有一次宣布和一次未宣布的晚餐）期间使用了新型全自动 CLC 系统 (RocketAP)。主要结果是突击餐后 70–180 mg/dL (TIR) 范围内的时间百分比，次要结果与额外的基于持续血糖监测的指标相关。

使用 RocketAP 后的 6 小时内，TIR 和紧缩范围内的时间 70–140 mg/dL (TTR) 显着高于使用 USS-Virginia（83% [四分位距 64–93] vs. 53 % [40–71]；P = 0.004 和 49% [41–59] vs. 27% [22–36]；分别为P = 0.002），主要是由于超范围时间减少（TAR >180 mg/ dL：17% [1.3–34] 与 47% [28–60]），低于范围的时间没有增加（TBR <70 mg/dL：两者的中位数均为 0%）。RocketAP 还在宣布餐后改善了控制（平均差异 TBR：–0.7%，TIR：+7%，TTR：+6%），总体（TIR：+5%，TAR：–5%，TTR：+8%）和过夜（TIR：+7%，TTR：+19%，TAR：–5%）。RocketAP 提供的胰岛素总体较少（78 ± 23 单位对 85 ± 20 单位，P = 0.01）。

具有自动膳食剂量的新型全自动 CLC 系统已被证明是安全可行的，并且在有和没有膳食通知的青少年人群中表现优于我们传统的 USS-Virginia。