Innovative solution or cause for concern? The use of continuous glucose monitors in people not living with diabetes: A narrative review

IF 3.2 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Diabetic Medicine Pub Date : 2024-06-26 DOI:10.1111/dme.15369

Zhanna Oganesova, John Pemberton, Adrian Brown

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Abstract

Aims

Continuous glucose monitors (CGMs) have expanded their scope beyond indicated uses for diabetes management and are gaining traction among people not living with diabetes (PNLD). CGMs track in time glucose levels and are proposed as tools for the early detection of abnormal glucose and a potential solution for its normalisation through behavioural change, particularly, diet personalisation and motivation of physical activity. This becomes relevance given the growing incidence of metabolic conditions, such as type 2 diabetes mellitus (T2DM). Clinical guidelines, however, do not recommend CGMs in contexts outside type 1 diabetes (T1DM) or insulin-treated T2DM. Therefore, there is a visible disconnect between the indicated and real-world usage of these medical devices. While the commercial market for CGMs in PNLD is expanding rapidly, a comprehensive and evidence-based evaluation of the devices' utility in this population has not been done. Therefore, this review aims to formulate a working model for CGM utility in PNLD as proposed by the ‘health and wellness’ market that advertises and distributes it to these individuals.

Methods

We aim to critically analyse the available research addressing components of the working model, that is (1) detection of abnormal glucose; (2) behavioural change, and (3) metabolic health improvement.

Results

We find a lack of consistent and high-quality evidence to support the utility of CGMs for these purposes. We identify significantly under-reserved areas including clinical benchmarks and scoring procedures for CGM measures, device acceptability, and potential adverse effects of CGMs on eating habits in PNLD. We also raise concerns about the robustness of available CGM research.

Conclusion

In the face of these research gaps, we urge for the commercial claims suggesting the utility of the device in PNLD to be labelled as misleading. We argue that there is a regulatory inadequacy that fuels ‘off-label’ CGM distribution and calls for the strengthening of post-market clinical follow-up oversight for CGMs. We hope this will help to avert the continued misinformation risk to PNLD and ‘off-label’ exacerbation of health disparities.

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创新的解决方案还是令人担忧的原因？连续血糖监测仪在非糖尿病患者中的使用：叙述性综述。

目的：连续式血糖监测仪（CGMs）的使用范围已经超出了糖尿病管理的指定用途，并在非糖尿病患者（PNLD）中获得了越来越多的关注。CGM 可及时跟踪血糖水平，是早期检测血糖异常的工具，也是通过改变行为（尤其是饮食个性化和体育锻炼激励）使血糖恢复正常的潜在解决方案。鉴于 2 型糖尿病（T2DM）等新陈代谢疾病的发病率不断上升，这一点变得尤为重要。然而，临床指南并不推荐在 1 型糖尿病（T1DM）或胰岛素治疗的 T2DM 以外的情况下使用 CGM。因此，这些医疗设备的指示用途和实际用途之间存在明显的脱节。尽管用于 PNLD 的 CGM 商业市场正在迅速扩大，但尚未对这些设备在这一人群中的实用性进行全面的循证评估。因此，本综述旨在为 CGM 在 PNLD 中的实用性制定一个工作模型，该模型由 "健康和保健 "市场提出，并向这些人宣传和分发：方法：我们旨在批判性地分析现有的研究，这些研究涉及工作模式的各个组成部分，即（1）检测异常血糖；（2）行为改变；以及（3）改善代谢健康：结果：我们发现缺乏一致的高质量证据来支持 CGM 在这些方面的实用性。我们发现了一些严重缺乏证据的领域，包括 CGM 测量的临床基准和评分程序、设备的可接受性以及 CGM 对 PNLD 饮食习惯的潜在不利影响。我们还对现有 CGM 研究的稳健性表示担忧：面对这些研究空白，我们敦促将暗示该设备对 PNLD 有用的商业声明标注为误导性声明。我们认为，监管不力助长了 CGM 的 "标示外 "销售，并呼吁加强对 CGM 上市后的临床跟踪监督。我们希望这将有助于避免对 PNLD 的持续误导风险和 "标示外 "健康差异的加剧。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetic Medicine 医学-内分泌学与代谢

CiteScore

7.20

自引率

5.70%

发文量

229

审稿时长

3-6 weeks

期刊介绍： Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions. The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed. We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services. Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”