一项糖尿病自我管理观察性研究，旨在调查持续葡萄糖监测（CGM）的使用如何影响糖尿病困扰、血糖水平以及作为低血糖意识的技术替代物发挥作用：一项研究方案。

Diabetes self-management observational study investigating how CGM use impacts diabetes distress, glycaemia and functions as a technological substitute for hypoglycaemia awareness: a study protocol.

作者信息

Nitschke Mette Juul, Demir Ceren, Brøsen Julie Maria Bøggild, Tapager Ingrid Willaing, Nørgaard Kirsten, Kristensen Peter Lommer, Pedersen-Bjergaard Ulrik

机构信息

Department of Endocrinology and Nephrology, Nordsjællands Hospital, Hillerød, Capital Region of Denmark, Denmark

Department of Endocrinology and Nephrology, Nordsjællands Hospital, Hillerød, Capital Region of Denmark, Denmark.

出版信息

BMJ Open. 2025 Sep 2;15(9):e103469. doi: 10.1136/bmjopen-2025-103469.

DOI:10.1136/bmjopen-2025-103469

PMID:40897486

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12414178/

Abstract

INTRODUCTION

Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.

METHODS AND ANALYSIS

This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.The collected data will be used in two substudies with the overall aims of:Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.Endpoints will include CGM metrics, alarm data and PROs.

ETHICS AND DISSEMINATION

The Danish Data Protection Agency approved the study (P-2024-15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.

CLINICALTRIALS

gov. Participants who agreed to receive information about the study will be sent the results after publication.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov (NCT06453434).

摘要

引言

持续葡萄糖监测（CGM）可为糖尿病患者提供实时血糖数据。然而，关于其在日常生活中的使用的详细知识仍然有限。我们旨在研究1型糖尿病（T1D）患者与其CGM数据之间的相互作用，以及这种相互作用对血糖和糖尿病困扰的影响。

方法与分析

这是一项针对500名使用FreeStyle Libre 2的成年T1D患者的两中心观察性研究。在14天的时间里，参与者将继续常规使用CGM，使用智能胰岛素笔记录胰岛素剂量和时间，使用活动追踪器跟踪活动和睡眠，在LibreLink应用程序中记录所有食物摄入量，并每天回答两次关于生活质量和低血糖的问题。在研究期之前，参与者将完成一项由11份经过验证的问卷组成的调查，评估糖尿病困扰、低血糖意识和其他患者报告的结果（PROs）。在研究期之后，参与者将完成另外两份评估糖尿病困扰和健康素养的问卷。收集到的数据将用于两项子研究，总体目标如下：

子研究1：研究CGM在实际中的使用方式以及这种相互作用对糖尿病困扰和血糖的影响。

子研究2：研究CGM是否以及如何作为低血糖意识受损的技术替代物，重点关注警报数据。

终点将包括CGM指标、警报数据和PROs。

伦理与传播

丹麦数据保护局批准了该研究（P-2024-15985），地区健康研究伦理委员会已给予伦理豁免（H-24014662）。所有参与者在参与之前均已签署书面知情同意书。研究结果将由研究调查人员发表在国际同行评审的科学期刊上，并通过www.clinicaltrials.gov分享。同意接收研究信息的参与者将在研究结果发表后收到结果。