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在临床糖尿病护理中使用持续葡萄糖监测和间歇性扫描葡萄糖监测评估系统性强化治疗:一项多中心随机临床试验方案

Evaluating a systematic intensive therapy using continuous glucose monitoring and intermittent scanning glucose monitoring in clinical diabetes care: a protocol for a multi-center randomized clinical trial.

作者信息

Ólafsdóttir Arndís F, Lind Marcus

机构信息

Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Department of Medicine, NU Hospital Group, Uddevalla, Sweden.

出版信息

Front Clin Diabetes Healthc. 2023 Oct 18;4:1247616. doi: 10.3389/fcdhc.2023.1247616. eCollection 2023.

DOI:10.3389/fcdhc.2023.1247616
PMID:37920192
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10619660/
Abstract

INTRODUCTION

As many people with type 1 diabetes find it hard to reach the recommended glycemic goals, even with CGM, this study aims to determine if a closer, digitally supported collaboration on interpreting CGM data together with a diabetes nurse can improve glycemic control.

METHODS AND ANALYSIS

A total of 120 individuals, 18 years and older and with HbA1c ≥ 58 mmol/mol will be included in the study at 8 different sites in Sweden and Norway. To be included, the participants must use a CGM or isCGM and be able to upload the data to the appropriate online service for their clinic and sensor. Both those with insulin pumps and insulin pens will be included in the study. Participants will be randomized into two different groups, that is, the intensive therapy group and the control group. The intensive therapy group will upload their glucose data weekly for the first 4 months and have telephone contact with their diabetes care team to receive support in interpreting CGM data and taking appropriate actions if their mean blood glucose level is above 8.4 mmol/L. After the 4-month-long intensive treatment phase, both randomized groups will have the same number of clinical visits and receive the same type of diabetes support.

DISCUSSION

It is of great importance to find new ways to help people with type 1 diabetes manage their condition as well as they can to help them achieve better glycemic control so that hopefully more people can achieve the recommended glycemic goals, which are associated with fewer diabetes complications. If it is shown that people with type 1 diabetes achieve better glycemic control with intensive therapy, then this can be incorporated into clinical praxis as an option for those not currently reaching the recommended glycemic goals.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov/study/NCT03474393?locStr=Uddevalla,%20Sweden&country=Sweden&distance=50&cond=Diabetes&aggFilters=ages:adult%20older&state=V%C3%A4stra%20G%C3%B6taland%20County&city=Uddevalla&page=4&rank=34, identifier 03474393.

摘要

引言

许多1型糖尿病患者发现即使使用持续葡萄糖监测(CGM)也难以达到推荐的血糖目标,因此本研究旨在确定与糖尿病护士一起更密切地、通过数字支持协作解读CGM数据是否能改善血糖控制。

方法与分析

瑞典和挪威的8个不同地点将纳入120名18岁及以上、糖化血红蛋白(HbA1c)≥58 mmol/mol的个体。要被纳入研究,参与者必须使用CGM或间歇性CGM(isCGM),并能够将数据上传到其诊所和传感器对应的在线服务。使用胰岛素泵和胰岛素笔的患者都将被纳入研究。参与者将被随机分为两组,即强化治疗组和对照组。强化治疗组在头4个月每周上传血糖数据,并与糖尿病护理团队进行电话联系,以获得解读CGM数据的支持,若其平均血糖水平高于8.4 mmol/L则采取适当行动。在为期4个月的强化治疗阶段后,两个随机分组的临床就诊次数将相同,并接受相同类型的糖尿病支持。

讨论

找到新方法帮助1型糖尿病患者尽可能好地管理病情、实现更好的血糖控制非常重要,这样有望让更多人达到推荐的血糖目标,从而减少糖尿病并发症。如果能证明1型糖尿病患者通过强化治疗实现了更好的血糖控制,那么这可以作为一种选择纳入临床实践,供目前未达到推荐血糖目标的患者使用。

临床试验注册

https://clinicaltrials.gov/study/NCT03474393?locStr=Uddevalla,%20Sweden&country=Sweden&distance=50&cond=Diabetes&aggFilters=ages:adult%%20older&state=V%C3%A4stra%20G%C3%B6taland%20County&city=Uddevalla&page=4&rank=34,标识符03474393 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f3e/10619660/21d0c8e7bbe6/fcdhc-04-1247616-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f3e/10619660/21d0c8e7bbe6/fcdhc-04-1247616-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f3e/10619660/21d0c8e7bbe6/fcdhc-04-1247616-g001.jpg

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