Céline I Laesser, Camillo Piazza, Nina Schorno, Fabian Nick, Lum Kastrati, Thomas Zueger, Katharine Barnard-Kelly, Malgorzata E Wilinska, Christos T Nakas, Roman Hovorka, David Herzig, Daniel Konrad, Lia Bally
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions/interpretation: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05481034.</p><p><strong>Funding: </strong>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. 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引用次数: 0
摘要
目的/假设：大多数混合闭环系统仍然需要碳水化合物计数（CC），但证明其合理性的证据仍然有限。在此，我们使用 mylife CamAPS FX 系统对患有 1 型糖尿病的青年和年轻成人进行了简化膳食公布 (SMA) 与碳水化合物计数的血糖控制评估：我们在瑞士的两所大学医院开展了一项双中心、随机交叉、非劣效试验，46 名 1 型糖尿病患者（12-20 岁）在入组前使用了每日多次注射疗法（35 人）、传感器增强泵疗法（4 人）或混合闭环疗法（7 人）。参与者使用 mylife CamAPS FX 系统（YpsoPump、Dexcom G6）进行为期 3 个月的两个疗程，比较 SMA（个性化碳水化合物膳食量）和 CC，使用计算机生成的序列随机分配顺序。主要终点是血糖处于目标范围（3.9-10.0 mmol/l）的时间比例，非劣效差为 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：43 名参与者（18 名女性和女孩）完成了试验。在意向治疗分析中，SMA 和 CC 的血糖控制时间（平均值±SD）分别为 69.9±12.4%和 70.7±13.0%（估计平均差异为-0.6 个百分点[95% CI -2.4，1.1]，表明非劣效性）。不同时期的 10.0 mmol/l 时间（28.2±12.6% vs 27.2±13.4%）相似。SMA的每日胰岛素总剂量更高（54.0±14.7 U vs 51.7±12.1 U，P=0.037）。三名参与者出现严重不良事件，但均与干预无关：结论/解释：在1型糖尿病青少年患者中，使用CamAPS FX算法和SMA控制血糖的效果不优于使用CC控制血糖的效果：试验注册：ClinicalTrials.gov NCT05481034.Funding：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 YTCR 基金的支持。Dexcom 和 Ypsomed 提供了产品支持。
Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes: a randomised controlled two-centre crossover trial.
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.
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.
期刊介绍：
Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.
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