Aims/hypothesis

The majority of hybrid closed-loop systems still require carbohydrate counting (CC) but the evidence for its justification remains limited. Here, we evaluated glucose control with simplified meal announcement (SMA) vs CC in youth and young adults with type 1 diabetes using the mylife CamAPS FX system.

Methods

We conducted a two-centre, randomised crossover, non-inferiority trial in two University Hospitals in Switzerland in 46 participants (aged 12–20 years) with type 1 diabetes using multiple daily injections (n=35), sensor-augmented pump (n=4) or hybrid closed-loop (n=7) therapy before enrolment. Participants underwent two 3 month periods with the mylife CamAPS FX system (YpsoPump, Dexcom G6) to compare SMA (individualised carbohydrate meal sizes) with CC, in a randomly assigned order using computer-generated sequences. The primary endpoint was the proportion of time glucose was in target range (3.9–10.0 mmol/l) with a non-inferiority margin of 5 percentage points. Secondary endpoints were other sensor glucose and insulin metrics, usability and safety endpoints.

Results

Forty-three participants (18 women and girls) completed the trial. In the intention-to-treat analysis, time in range (mean±SD) was 69.9±12.4% with SMA and 70.7±13.0% with CC (estimated mean difference −0.6 percentage points [95% CI −2.4, 1.1], demonstrating non-inferiority). Time <3.9 mmol/l (median [IQR] 1.8 [1.2–2.2]% vs 1.9 [1.6–2.5]%) and >10.0 mmol/l (28.2±12.6% vs 27.2±13.4%) was similar between periods. Total daily insulin dose was higher with SMA (54.0±14.7 U vs 51.7±12.1 U, p=0.037). Three participants experienced serious adverse events, none of which were intervention-related.

Conclusions/interpretation

Glucose control using the CamAPS FX algorithm with SMA was non-inferior to its use with CC in youth and young adults with type 1 diabetes.

Trial registration

ClinicalTrials.gov NCT05481034.

Funding

The study was supported by the Swiss Diabetes Foundation and by a YTCR grant from the Bangerter-Rhyner Foundation and the Swiss Academy of Medical Sciences. Dexcom and Ypsomed provided product support.

Graphical Abstract

中文翻译：

---

在 1 型糖尿病青年和年轻人中使用混合闭环胰岛素输送的简化膳食公告研究 （SMASH）：一项随机对照双中心交叉试验

 目标/假设

大多数混合闭环系统仍然需要碳水化合物计数 （CC），但其理由的证据仍然有限。在这里，我们使用 mylife CamAPS FX 系统评估了患有 1 型糖尿病的青年和年轻人通过简化膳食公告 （SMA） 与 CC 进行血糖控制。

 方法

我们在瑞士的两所大学医院进行了一项双中心、随机交叉、非劣效性试验，涉及 46 名 1 型糖尿病参与者 （年龄 12-20 岁），在入组前使用每日多次注射 （n=35）、传感器增强泵 （n=4） 或混合闭环 （n=7） 疗法。参与者使用 mylife CamAPS FX 系统（YpsoPump、Dexcom G6）进行了两个为期 3 个月的测试，以使用计算机生成的序列以随机分配的顺序比较 SMA（个体化碳水化合物膳食量）与 CC。主要终点是葡萄糖在目标范围 （3.9-10.0 mmol/l） 的时间比例，非劣效性边际为 5 个百分点。次要终点是其他传感器葡萄糖和胰岛素指标、可用性和安全性终点。

 结果

43 名参与者 （18 名妇女和女孩） 完成了试验。在意向治疗分析中，SMA 的范围内时间 （mean±SD） 为 69.9±12.4%，CC 为 70.7±13.0%（估计平均差 -0.6 个百分点 [95% CI -2.4， 1.1]，证明非劣效性）。时间 <3.9 mmol/l（中位数 [IQR] 1.8 [1.2–2.2]% vs 1.9 [1.6–2.5]%） 和 >10.0 mmol/l（28.2±12.6% vs 27.2±13.4%）在各个时期之间相似。SMA 的每日总胰岛素剂量较高 （54.0±14.7 U vs 51.7±12.1 U，p=0.037）。3 名参与者经历了严重的不良事件，其中没有一个与干预相关。

结论/解释

在 1 型糖尿病青年和年轻人中，使用 CamAPS FX 算法和 SMA 进行血糖控制并不劣于其与 CC 一起使用。

 试用注册

ClinicalTrials.gov NCT05481034。

 资金

该研究得到了瑞士糖尿病基金会以及 Bangerter-Rhyner 基金会和瑞士医学科学院的 YTCR 资助的支持。Dexcom 和 Ypsomed 提供了产品支持。

 图形摘要