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Simplera Sync™传感器和Extended™长效输注套装对既往HbA1c水平较高的儿童和青年患者使用美敦力™780G系统时血糖及系统性能的影响

Impact of Simplera Sync™ sensors and Extended™ Wear Infusion Sets on glycaemia and system performance of the MiniMed™ 780G system in children and young adults with previously high HbA1c.

作者信息

Michaels Venus R, Boucsein Alisa, Zhou Yongwen, Jones Shirley D, Paul Ryan G, Wiltshire Esko, Jefferies Craig, de Bock Martin I, Wheeler Benjamin J

机构信息

Department of Paediatrics and Child Health, University of Otago, Dunedin, New Zealand.

Guangdong Provincial Key Laboratory of Diabetology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.

出版信息

Diabet Med. 2025 Jul;42(7):e70048. doi: 10.1111/dme.70048. Epub 2025 Apr 18.

Abstract

AIMS

The MiniMed™ 780G improves glycaemia and reduces burden in type 1 diabetes. We investigated how new all-in-one "Simplera Sync™" sensors and 7-day Extended™ Wear Infusion Sets (EIS) affect glycaemia and system performance in young people with previously elevated HbA1c levels (≥69 mmol/mol [≥8%]) after transitioning from 780G with Guardian 4™ sensors and 3-day infusion sets.

METHODS

We conducted an extension phase analysis in 75 participants (aged 7-25 years) initially enrolled in the CO-PILOT randomised controlled trial. For this analysis, baseline was defined as the period following the use of 780G with Guardian 4™ sensors and 3-day infusion sets. Participants then transitioned to 780G with Simplera Sync™ and EIS. We compared glycaemic and system performance outcomes from baseline to those after the transition to 780G with Simplera Sync™ and EIS.

RESULTS

Baseline HbA1c was 66.1 mmol/mol ± 14.2 mmol/mol and remained stable at 66.7 mmol/mol ± 11.2 mmol/mol after the transition (p = 0.38). Time in range (3.9-10.0 mmol/L [70-180 mg/dL]) at baseline was 58.5% ± 14.9% and 60.4% ± 15.7% after transition (p = 0.09). Time in tight range (3.9-7.8 mmol/L [70-140 mg/dL]) increased from 38.1% ± 13.1% at baseline to 40.5% ± 13.6% after the transition (p = 0.04). While using 780G with Simplera Sync™ and EIS, automation time increased from baseline 79.2% ± 25.9% to 85.8% ± 21.8% (p = 0.007), and sensor wear time from 80.7% ± 22.4% at baseline to 88.4% ± 17.2% (p < 0001).

CONCLUSIONS

Simplera Sync™ and EIS improved time in automation and sensor wear time when using 780G AHCL in this high-risk young population. This was associated with incremental improvement in time in tight range despite the challenges of this population.

摘要

目的

美敦力780G胰岛素泵系统可改善1型糖尿病患者的血糖水平并减轻负担。我们研究了新型一体化的“Simplera Sync™”传感器和7天长效输注套装(EIS)在从使用780G胰岛素泵系统搭配Guardian 4™传感器和3天输注套装转换后,对既往糖化血红蛋白(HbA1c)水平升高(≥69 mmol/mol [≥8%])的年轻人的血糖水平和系统性能有何影响。

方法

我们对最初纳入CO-PILOT随机对照试验的75名参与者(年龄7 - 25岁)进行了扩展阶段分析。对于该分析,基线定义为使用780G胰岛素泵系统搭配Guardian 4™传感器和3天输注套装之后的时期。参与者随后转换为使用780G胰岛素泵系统搭配Simplera Sync™传感器和EIS。我们比较了从基线到转换为使用780G胰岛素泵系统搭配Simplera Sync™传感器和EIS后的血糖和系统性能结果。

结果

基线时HbA1c为66.1 mmol/mol ± 14.2 mmol/mol,转换后稳定在66.7 mmol/mol ± 11.2 mmol/mol(p = 0.38)。基线时血糖在目标范围内(3.9 - 10.0 mmol/L [70 - 180 mg/dL])的时间为58.5% ± 14.9%,转换后为60.4% ± 15.7%(p = 0.09)。血糖在严格目标范围内(3.9 - 7.8 mmol/L [70 - 140 mg/dL])的时间从基线时的38.1% ± 13.1%增加到转换后的40.5% ± 13.6%(p = 0.04)。在使用780G胰岛素泵系统搭配Simplera Sync™传感器和EIS时,自动化时间从基线时的79.2% ± 25.9%增加到85.8% ± 21.8%(p = 0.007),传感器佩戴时间从基线时的80.7% ± 22.4%增加到88.4% ± 17.2%(p < 0.0001)。

结论

在这个高风险的年轻人群中,使用780G胰岛素泵系统搭配Simplera Sync™传感器和EIS时,Simplera Sync™传感器和EIS改善了自动化时间和传感器佩戴时间。尽管该人群存在诸多挑战,但这与血糖在严格目标范围内时间的逐步改善相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f253/12151811/a36d0c92538a/DME-42-e70048-g001.jpg

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