Schedule of procedures and assessments.

BackgroundHbA1c targets guide diabetes management to reduce complications, yet their psychological effects are poorly understood. This feasibility study evaluated the practicality of conducting a definitive trial evaluating the impact of explicit HbA1c target-setting in adults with diabetes.MethodsWe conducted a randomised mixed-methods feasibility study. Adults with diabetes were allocated 1:1 to receive an explicit HbA1c target set 5 mmol/mol above (Group A) or below (Group B) their current HbA1c. Biomedical (HbA1c, blood pressure, BMI) and psychometric patient-reported outcomes were measured at baseline and 3 months. Quantitative data were analysed in SPSS using independent-sample t-tests or Mann–Whitney U tests for between-group comparisons, and paired t-tests or Wilcoxon signed-rank tests for within-group changes. Qualitative data from semi-structured interviews with patients and healthcare professionals were analysed using the Framework Method of thematic analysis in NVivo. Acceptability was assessed via interview, and mixed-methods findings were integrated through triangulation to enhance validity.ResultsFifty participants were recruited; 34% withdrew. Though not powered to determine statistical significance, no between-group differences were observed in HbA1c or patient-reported outcomes. Across groups, diabetes distress decreased, self-efficacy improved, and HbA1c improved. Interviews indicated high acceptability and identified key motivators (target achievability, hypoglycaemia avoidance) and demotivators (limited understanding, perceived unattainability).DiscussionA randomised mixed-methods approach to HbA1c target-setting is feasible and acceptable, providing methodological insights for a definitive trial.Trial registrationThe study is registered with the ISRCTN (registration number: 12461724; date registered: 11th June 2021).背景 糖化血红蛋白（HbA1c）目标值是糖尿病管理以降低并发症的核心依据，但其对患者的心理影响却鲜为人知。本可行性研究旨在评估开展确证性试验的可行性，该确证性试验将探究明确糖化血红蛋白目标值设定对成年糖尿病患者的影响。 方法 本研究采用随机混合方法可行性研究设计。将成年糖尿病患者按1:1随机分配，分别接受较当前HbA1c高5毫摩尔每摩尔（A组）或低5毫摩尔每摩尔（B组）的明确HbA1c目标值干预。分别于基线及3个月时采集生物医学结局指标（HbA1c、血压、体重指数（BMI））及患者报告的心理测量学结局指标。 采用统计分析软件SPSS对定量数据进行分析：组间比较采用独立样本t检验或曼-惠特尼U检验，组内变化分析采用配对t检验或威尔科克森符号秩检验。对患者与医护人员的半结构化访谈所得定性数据，采用质性分析软件NVivo中的主题分析框架法进行编码分析。通过访谈评估研究的可接受性，并采用三角验证法整合混合方法研究结果以提升研究效度。 结果 本研究共招募50名参与者，34%的患者中途脱落。由于本研究未设定检验效能以检测统计学显著性，组间HbA1c及患者报告结局指标均未观察到显著差异。整体而言，两组患者的糖尿病痛苦均有所缓解，自我效能感得到提升，HbA1c水平亦有所改善。访谈结果显示患者对该干预的可接受度较高，同时明确了核心驱动因素（目标可达成性、低血糖规避）与阻碍因素（认知不足、感知目标难以达成）。 讨论 针对糖化血红蛋白目标值设定的随机混合方法研究具备可行性与可接受性，可为后续确证性试验提供方法论参考。 试验注册 本研究已在国际随机对照试验注册库（ISRCTN）完成注册，注册号：12461724；注册日期：2021年6月11日。