Department of Diabetes and Endocrinology, St Helens Hospital, Mersey and West Lancashire Teaching Hospitals NHS Trust, St Helens, UK.
Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.
Diabet Med. 2024 Dec;41(12):e15430. doi: 10.1111/dme.15430. Epub 2024 Sep 5.
Structured diabetes self-management education (DSME) is internationally recommended for people with type 2 diabetes to support self-management and to prevent associated long-term complications. 'Attendance' at DSME is currently benchmarked as having completed a registration form and at least one active engagement with programme content, and 'completion' measured against ≥60% completion, despite landmark trials reporting outcomes based on the full completion of a programme. Little is known about the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme. We report a protocol for a single-centre randomised feasibility study to assess the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes of self-care, diabetes distress and quality of life in people with type 2 diabetes.
A randomised feasibility study in 120 people with type 2 diabetes due to attend a secondary care diabetes clinic in the North West UK for DSME. Participants will be randomised into one of the four groups: Group 1 full DSME programme, Group 2 60%, Group 3 10% and Group 4 0% (delayed education). Psychometric questionnaire scores will be evaluated at baseline and 3-4 months post-intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported.
The DIABETES-PRO study was approved by the London-Surrey Borders Research Ethics Committee (24/LO/0235). Results will be shared with study participants and published in peer-reviewed journals.
Clinicaltrials.gov NCT06419907.
结构化的糖尿病自我管理教育（DSME）被国际推荐用于 2 型糖尿病患者，以支持自我管理并预防相关的长期并发症。目前，DSME 的“参与”基准是完成注册表格和至少一次与计划内容的积极互动，而“完成”则根据≥60%的完成率来衡量，尽管标志性试验报告的结果是基于完整完成计划。对于完成少于完整 DSME 计划的糖尿病患者，DSME 对其心理和情绪健康的影响知之甚少。我们报告了一项单中心随机可行性研究的方案，以评估不同完成率的面对面 DSME 计划对 2 型糖尿病患者自我护理、糖尿病困扰和生活质量的患者报告结果的影响。
在英国西北部的一家二级保健糖尿病诊所，对 120 名即将接受 DSME 的 2 型糖尿病患者进行一项随机可行性研究。参与者将随机分为四组之一：第 1 组完成完整的 DSME 计划，第 2 组完成 60%，第 3 组完成 10%，第 4 组完成 0%（延迟教育）。将在基线和干预后 3-4 个月评估心理测量问卷评分。将报告可行性措施（合格性、招募率和保留率）。
DIABETES-PRO 研究获得了伦敦-萨里边境研究伦理委员会（24/LO/0235）的批准。结果将与研究参与者分享，并发表在同行评议的期刊上。
Clinicaltrials.gov NCT06419907。
