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用于监测囊性纤维化相关性糖尿病的连续血糖监测系统。

Continuous glucose monitoring systems for monitoring cystic fibrosis-related diabetes.

机构信息

Wirral University Teaching Hospital NHS Foundation Trust, Birkenhead, UK.

School of Medicine, University of Liverpool, Liverpool, UK.

出版信息

Cochrane Database Syst Rev. 2021 Nov 29;11(11):CD013755. doi: 10.1002/14651858.CD013755.pub2.

Abstract

BACKGROUND

Cystic fibrosis (CF) is one of the most common life-shortening autosomal-recessive genetic conditions with around 100,000 people affected globally. CF mainly affects the respiratory system, but cystic fibrosis-related diabetes (CFRD) is a common extrapulmonary co-morbidity and causes excess morbidity and mortality in this population. Continuous glucose monitoring systems (CGMS) are a relatively new technology and, as yet, the impact of these on the monitoring and subsequent management of CFRD remains undetermined.

OBJECTIVES

To establish the impact of insulin therapy guided by continuous glucose monitoring compared to insulin therapy guided by other forms of glucose data collection on the lives of people with CFRD.

SEARCH METHODS

We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of latest search: 23 September 2021. We also searched the reference lists of relevant articles and reviews and online trials registries. Date of last search: 23 September 2021.

SELECTION CRITERIA

Randomised controlled studies comparing insulin regimens led by data from CGMS (including real-time or retrospective data, or both) with insulin regimens guided by abnormal blood glucose measurements collected through other means of glycaemic data collection in people with CFRD. Studies with a cross-over design, even with a washout period between intervention arms, are not eligible for inclusion due to the potential long-term impact of each of the interventions and the potential to compromise the outcomes of the second intervention.

DATA COLLECTION AND ANALYSIS

No studies were included in the review, meaning that no data were available to be collected for analysis.

MAIN RESULTS

Review authors screened 14 studies at the full-text stage against the review's inclusion criteria. Consequently, seven were excluded due to the study type being ineligible (not randomised), two studies were excluded due to their cross-over design, and two studies was excluded since the intervention used was not eligible and one was a literature review. One study in participants hospitalised for a pulmonary exacerbation is ongoing. Investigators are comparing insulin dosing via insulin pump with blood sugar monitoring by a CGMS to conventional diabetes management with daily insulin injections (or on an insulin pump if already on an insulin pump in the outpatient setting) and capillary blood glucose monitoring. The participants in the control arm will wear a blinded continuous glucose monitoring system for outcome assessment. In addition to this, one further study is still awaiting classification, and will be screened to determine whether it is eligible for inclusion, or is to be excluded, in an update of this review.

AUTHORS' CONCLUSIONS: No studies were included in the review, indicating that there is currently insufficient evidence to determine the impact of insulin therapy guided by CGMS compared to insulin therapy guided by other forms of glucose data collection on the lives of people with CFRD, nor on potential adverse effects of continuous glucose monitoring in this context. Randomised controlled studies are needed to generate evidence on the efficacy and safety of continuous glucose monitoring in people with CFRD. There is one relevant ongoing study that may be eligible for inclusion in a future update of this Cochrane Review, and whose results may help answer the review question.

摘要

背景

囊性纤维化(CF)是最常见的缩短生命的常染色体隐性遗传疾病之一,全球约有 10 万人受到影响。CF 主要影响呼吸系统,但囊性纤维化相关糖尿病(CFRD)是一种常见的肺外合并症,并导致该人群的发病率和死亡率增加。连续血糖监测系统(CGMS)是一种相对较新的技术,迄今为止,这些技术对 CFRD 的监测和后续管理的影响仍不确定。

目的

确定由连续血糖监测指导的胰岛素治疗与由其他形式的血糖数据收集指导的胰岛素治疗对 CFRD 患者生活的影响。

检索方法

我们检索了 Cochrane 囊性纤维化试验注册库,该注册库是通过电子数据库搜索以及期刊和会议摘要书籍的手工搜索编制而成的。最新检索日期:2021 年 9 月 23 日。我们还检索了相关文章和综述的参考文献列表以及在线试验注册处。最新检索日期:2021 年 9 月 23 日。

选择标准

比较由 CGMS(包括实时或回顾性数据或两者)数据指导的胰岛素方案与通过其他血糖数据收集方法收集的异常血糖测量值指导的胰岛素方案的随机对照研究,在 CFRD 患者中。具有交叉设计的研究,即使在干预臂之间有洗脱期,也不符合纳入标准,因为每个干预措施的长期影响以及对第二次干预结果的潜在影响都不符合纳入标准。

数据收集和分析

没有研究被纳入审查,这意味着没有数据可用于分析。

主要结果

综述作者在全文阶段根据综述的纳入标准筛选了 14 项研究。因此,由于研究类型不合格(非随机),有 7 项被排除在外,由于交叉设计,有 2 项被排除在外,由于干预措施不合格,有 2 项被排除在外,还有 1 项是文献综述。一项针对因肺部恶化住院的参与者的研究正在进行中。研究人员正在比较通过胰岛素泵进行胰岛素给药与 CGMS 进行血糖监测与常规糖尿病管理(每天注射胰岛素或已在门诊环境中使用胰岛素泵的情况下使用胰岛素泵)和毛细血管血糖监测。对照组的参与者将佩戴盲法连续血糖监测系统进行结果评估。除此之外,还有一项进一步的研究仍在等待分类,将对其进行筛选,以确定它是否符合纳入标准,或者是否应在本综述的更新中排除在外。

作者结论

没有研究被纳入审查,这表明目前尚无足够证据确定 CGMS 指导的胰岛素治疗与其他形式的血糖数据收集指导的胰岛素治疗对 CFRD 患者生活的影响,也无法确定连续血糖监测在这种情况下的潜在不良影响。需要随机对照研究来提供关于 CFRD 患者连续血糖监测的疗效和安全性的证据。有一项相关的正在进行的研究可能有资格纳入本 Cochrane 综述的未来更新,其结果可能有助于回答综述问题。

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本文引用的文献

2
Effect of CFTR modulator therapy on cystic fibrosis-related diabetes.囊性纤维化相关糖尿病的 CFTR 调节剂治疗效果。
J Diabetes Complications. 2021 Jun;35(6):107845. doi: 10.1016/j.jdiacomp.2020.107845. Epub 2021 Jan 5.
4
7. Diabetes Technology: .7. 糖尿病技术:。
Diabetes Care. 2020 Jan;43(Suppl 1):S77-S88. doi: 10.2337/dc20-S007.

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