在 Hypo-METRICS 研究的 10 周内，临床、心理和社会人口统计学特征以及生态瞬时评估完成情况的关联：低血糖 MEasurements ThResholds 和 ImpaCtS。

Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo-METRICS study: Hypoglycaemia MEasurements ThResholds and ImpaCtS.

机构信息

Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.

Medical & Science, Patient Focused Drug Development, Novo Nordisk A/S, Søborg, Denmark.

出版信息

Diabet Med. 2024 Aug;41(8):e15345. doi: 10.1111/dme.15345. Epub 2024 May 17.

DOI:10.1111/dme.15345

PMID:38760977

Abstract

INTRODUCTION

Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin-treated type 2 diabetes in real-time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion.

METHODS

Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics.

RESULTS

In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45-66) years; diabetes duration 19 (11-27) years; HbA1c 57 (51-65) mmol/mol), median(IQR) overall app completion rate was 91 (84-96)%, ranging from 90 (81-96)%, 89 (80-94)% and 94(87-97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion.

DISCUSSION

High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time.

摘要

简介

在临床研究中，低血糖的报告及其影响通常是回顾性的，易受回忆偏倚的影响。我们开发了 Hypo-METRICS 应用程序，使用生态瞬时评估（EMA）实时测量 1 型和胰岛素治疗的 2 型糖尿病成人的低血糖对身体、心理和社会的日常影响。为了帮助评估其效用，我们旨在确定 Hypo-METRICS 应用程序的完成率和与完成相关的因素。

方法

在 Hypo-METRICS 研究中招募的糖尿病成人在基线时接受了经过验证的患者报告结局测量（PROM）。在 10 周内，他们佩戴了盲法连续血糖监测仪（CGM），并被要求完成三次关于低血糖和日常功能方面的每日 EMA，以及两次关于睡眠和生产力的每周 PROM 在定制的 Hypo-METRICS 应用程序上。我们进行了线性回归，以确定与应用程序参与相关的因素，通过 EMA 和 PROM 完成率和 CGM 指标进行评估。

结果

在 602 名参与者（55%为男性；54%为 2 型糖尿病；中位（IQR）年龄 56（45-66）岁；糖尿病病程 19（11-27）年；HbA1c 57（51-65）mmol/mol）中，总体应用程序完成率的中位数（IQR）为 91（84-96）%，范围从 90（81-96）%、89（80-94）%和 94（87-97）%分别为早晨、下午和晚上的检查。年龄较大、常规使用 CGM、低于 3.0mmol/L 的时间更长以及活跃的传感器时间与应用程序完成呈正相关。