Background: The advanced hybrid closed-loop (AHCL) algorithm combines automated basal rates and corrections yet requires meal announcement for optimal outcomes. We aimed to compare the performance of the MiniMed™ 780G AHCL algorithm with and without meal announcement. Methods: In a single-arm study involving 14 adults with type 1 diabetes, we evaluated the safety and efficacy of AHCL when meals were not announced. Participants stayed at a supervised environment for 5 days, during which the outcomes of not announcing meals (≤80 g of carbohydrate) were assessed. Next, participants entered a 90-day at-home "unannounced" phase, during which all meals (≤80 g of carbohydrate) were unannounced, followed by a 90-day at-home phase in which all meals were announced. Results: Time in range (TIR 70-180 mg/dL) was lower in the unannounced versus announced periods (67.5% ± 12.5% vs. 77.7% ± 9.5%; P < 0.01, respectively), with more time spent in hyperglycemia range 180-250 mg/dL (22.7% ± 7.7% vs. 15.7% ± 7.2%) and >250 mg/dL (7.9% ± 6.4% vs. 3.6% ± 2.7%), but less time in hypoglycemia range 54-70 mg/dL (1.6% ± 1% vs. 2.8% ± 1.8%) and <54 mg/dL (0.3% ± 0.4% vs. 0.7% ± 0.9%). Not announcing meals containing up to 60 g of carbohydrate did not lead to increase in postprandial extreme dysglycemia >250 mg/dL, and up to 20 g of unannounced carbohydrates did not significantly change the TIR 70-180 mg/dL compared with full announcement. Conclusion: The AHCL system is optimized for use with meal announcement. While not announcing meals of ≤80 g carbohydrates appears to be safe, it results in suboptimal postprandial glycemic control, especially with high-carbohydrate meals. Not announcing small meals (≤20 g carbohydrate) does not deteriorate glycemic control. Clinical Trial Registration number: NCT04479826.

中文翻译：

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使用先进的混合闭环系统进行突击膳食挑战。

背景：先进的混合闭环 (AHCL) 算法结合了自动基础率和校正，但需要膳食公告才能获得最佳结果。我们的目的是比较 MiniMed™ 780G AHCL 算法在有和没有膳食通知的情况下的性能。方法：在一项涉及 14 名 1 型糖尿病成人的单臂研究中，我们评估了未通知进餐时 AHCL 的安全性和有效性。参与者在受监督的环境中呆了 5 天，在此期间评估不通知膳食（≤80 克碳水化合物）的结果。接下来，参与者进入为期 90 天的在家“未经通知”阶段，在此期间所有膳食（≤ 80 克碳水化合物）均未经通知，随后是 90 天在家阶段，其中所有膳食均已公布。结果：未公布期间的范围时间 (TIR 70-180 mg/dL) 与公布期间相比较低（分别为 67.5% ± 12.5% 与 77.7% ± 9.5%；P < 0.01），处于高血糖范围的时间更长180-250 mg/dL（22.7% ± 7.7% 对比 15.7% ± 7.2%）和 >250 mg/dL（7.9% ± 6.4% 对比 3.6% ± 2.7%），但处于低血糖范围的时间较短 54-70 mg/dL（1.6% ± 1% 对比 2.8% ± 1.8%）和 <54 mg/dL（0.3% ± 0.4% 对比 0.7% ± 0.9%）。未公布的膳食中碳水化合物含量不超过 60 g 不会导致餐后极度血糖异常增加 >250 mg/dL，并且与完全公布相比，未公布的碳水化合物含量高达 20 g 不会显着改变 TIR 70-180 mg/dL。结论：AHCL 系统针对用餐通知进行了优化。虽然不宣布膳食中碳水化合物含量≤80克似乎是安全的，但它会导致餐后血糖控制不佳，尤其是高碳水化合物膳食。不提倡少食多餐（≤20克碳水化合物）不会恶化血糖控制。临床试验注册号：NCT04479826。