Data for Insulin Non-Adherence in Type 1 Diabetes.xlsx

Design

A cross-sectional, web-based survey design was employed, consisting of validated self-report measures designed to capture demographic information, insulin use, diabetes-related distress, disordered eating, and body shape perception.
Inclusion/Exclusion criteria. Participants were eligible to participate if they self-described as being aged 18 or over, with a diagnosis of Type 1 diabetes and on a prescribed insulin regimen. They were required to be at least one-year post-diagnosis, as people who have been prescribed insulin for less than one year may not have settled into a routine with insulin management and may mismanage their insulin unintentionally. Additionally, participants were required to reside within the UK, as this removed a potential confound of cost or resources as a barrier to accessing insulin.
People with a diagnosis of type 2 diabetes were excluded from the study, as the pathophysiology and treatment of the two illnesses are quite different. For example, as those with type 2 diabetes still produce some degree of insulin naturally, non-adherence to an insulin regimen is likely to have less of an immediate impact than for those with type 1 diabetes, who produce no insulin naturally (Peyrot et al., 2010).
Potential participants were provided with a link to the study which provided detailed information about the study, details of informed consent and their right to withdraw. When the survey was completed, or participants chose to exit, a debrief page was presented with signposts towards various supports and resources. Participants were offered the opportunity to receive a brief summary of findings from the study and given the chance to win a £25 Amazon gift voucher, both of which required an email address to be supplied through separate surveys, so as to protect the confidentiality of responses. Ethical approval for this study was granted by the chair of the relevant Ethics Committee.
Statistical Analysis
Prior to beginning the study, an estimate of the minimum number of participants required was calculated using statistical power tables (Clark-Carter, 2010) and G*Power version 3.1. Based on previous research (Ames, 2017), a medium effect size (.5) was used to calculate sample sizes with a power of .8 (Clark-Carter, 2010), which generated a necessary sample size of 208. All analyses were adequately powered.
Data were analysed using IBM SPSS Statistics for Mac version 25.
Measures
Demographic Information. This section collected basic demographic information, including age; gender; country of residence; and current or historical diagnosis of an eating disorder. The data were screened to ensure participants met the inclusion criteria.
Insulin Measure. A 16-item questionnaire has been designed to assess rates and reasons for insulin non-adherence (Ames, 2017).
Eating Disorder Psychopathology. The Eating Disorder Examination-Questionnaire (EDE-Q) assesses eating disorder psychopathology, and data from this measure was key to informing the primary research questions. It was designed as a self-report version of the interview-based Eating Disorders Examination (EDE; 32), which is considered to be the gold standard measure (Fairburn, Wilson, & Schleimer, 1993). The EDE-Q assesses four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. It was found to be an adequate alternative to the EDE (Fairburn & Beglin, 1994).
Body Shape Questionnaire (BSQ). The Body Shape Questionnaire is a 34-item self-report measure, designed to assess concerns regarding body shape and the phenomenological experience of “feeling fat” (Cooper, Taylor, Cooper, & Fairbum, 1987). The BSQ targets body image as a central feature of both AN and BN and thus is a useful supplementary measure of eating disorder psychopathology.
Diabetes Distress. The Diabetes Distress Scale (Polonsky et al., 2005) is a 17-item scale designed to measure diabetes-related emotional distress via four domains: emotional burden, physician distress, interpersonal distress and regimenn distress. This measure was included on the basis of results from Ames (Ames, 2017), which identified diabetes-related emotional distress as a key reason for insulin non-adherence in type 1 diabetes. Inclusion in this study allowed for further investigation of its role.

研究设计
本研究采用横断面网络调查设计，使用经过信效度验证的自报告量表，采集人口统计学信息、胰岛素使用情况、糖尿病相关困扰、进食紊乱及体型感知相关数据。

纳入与排除标准
参与者需满足以下条件方可参与：自我报告年满18岁，确诊1型糖尿病（Type 1 diabetes）且接受医嘱胰岛素治疗方案；确诊时长至少满1年——因确诊不足1年的患者尚未适应胰岛素管理流程，可能出现无意的胰岛素使用不当。此外，参与者需居住在英国（UK），以排除医疗成本或资源可及性作为胰岛素获取障碍的潜在混杂因素。
本研究排除2型糖尿病患者，因两种疾病的病理生理机制与治疗方案存在显著差异：2型糖尿病患者仍可分泌一定量的内源性胰岛素，其不遵医嘱胰岛素治疗方案的即时影响远低于完全无法分泌内源性胰岛素的1型糖尿病患者（Peyrot等，2010）。

潜在参与者将获得研究链接，其中包含研究详细信息、知情同意说明及退出研究的权利说明。参与者完成问卷或主动退出后，将看到研究告知页面，并附带各类支持资源的指引。本研究为参与者提供两项可选福利：获取研究结果简要摘要，以及参与25英镑亚马逊（Amazon）礼品卡抽奖，两项福利均需通过独立问卷提供电子邮箱地址，以保障问卷作答的保密性。本研究已获得相关伦理委员会主席的伦理审批。

统计分析
研究启动前，采用统计功效表（Clark-Carter，2010）与G*Power 3.1版本软件计算最小所需样本量。基于既往研究（Ames，2017），本研究设定中等效应量为0.5，统计功效为0.8，据此计算得到所需最小样本量为208例，所有分析均具备足够统计功效。
数据分析采用适用于Mac的IBM SPSS Statistics 25版本软件完成。

测量工具
1. 人口统计学信息
该部分采集基础人口统计学数据，包括年龄、性别、居住国，以及当前或既往进食障碍诊断史。研究人员将对数据进行筛查，以确认参与者符合纳入标准。
2. 胰岛素使用情况量表
该16项问卷用于评估胰岛素不遵医嘱行为的发生率及原因（Ames，2017）。
3. 进食障碍精神病理学评估工具
进食障碍检查问卷（Eating Disorder Examination-Questionnaire, EDE-Q）用于评估进食障碍精神病理学特征，其数据为解答本研究核心问题的关键依据。该问卷为访谈版进食障碍检查（Eating Disorders Examination, EDE；32）的自报告版本，而EDE被视为进食障碍评估的金标准测量工具（Fairburn、Wilson & Schleimer，1993）。EDE-Q包含四个分量表：约束进食、进食关注、体型关注与体重关注，已被证实可作为EDE的有效替代工具（Fairburn & Beglin，1994）。
4. 体型问卷（Body Shape Questionnaire, BSQ）
该34项自报告量表用于评估体型相关担忧及“感觉肥胖”的现象学体验（Cooper、Taylor、Cooper & Fairburn，1987）。BSQ聚焦于神经性厌食（AN）与神经性贪食（BN）的核心特征——体型意象，因此是评估进食障碍精神病理学的有效补充工具。
5. 糖尿病困扰量表
糖尿病困扰量表（Diabetes Distress Scale，Polonsky等，2005）为17项量表，通过四个维度评估糖尿病相关情绪困扰：情绪负担、医师相关困扰、人际困扰与治疗方案困扰。本研究纳入该量表的依据来自Ames（2017）的研究结果，该研究指出糖尿病相关情绪困扰是1型糖尿病患者胰岛素不遵医嘱行为的关键诱因，本研究可进一步探究其在该群体中的作用。