Welford Anneka E, Ridgeway James, Gillies Clare, Choudhary Pratik, Hegde Vidya, Khunti Kamlesh, Seidu Samuel
Leicester Diabetes Centre, Leicester General Hospital, University of Leicester, Gwendolen Rd, Leicester, LE5 4PW, UK.
National Institute for Health and Care Research (NIHR), Applied Research Collaboration East Midlands (ARC EM), Leicester, UK.
Diabetes Ther. 2025 Jul;16(7):1511-1524. doi: 10.1007/s13300-025-01740-9. Epub 2025 May 8.
Overprescribing is common in older adults with diabetes, potentially leading to hospitalisation and reduced quality of life. Additionally, diabetes care in older adults is often complicated by multiple interacting conditions and cognitive impairment, resulting in challenging self-management. Although evidence suggests that de-intensification of medications is safe in older adults, there are no data evaluating glucose ranges during this process.
eDMED is a 12-week feasibility study including 49 adults, aged ≥ 65 years with type 2 diabetes and residing in care homes. All eligible participants will receive medication de-intensification and continuous glucose monitoring (CGM). Primary healthcare professionals (HCPs) will undergo structured training on a de-intensification algorithm and CGM, while care home staff will receive tailored education on diabetes management and CGM application to ensure safe and effective implementation.
The primary outcome is the percentage of participants achieving a composite of > 50% time in range and < 1% time below range at 12 weeks, measured via CGM. Secondary outcomes include trends in time above and below range (quantified by level of hyper- or hypoglycaemia), change in quality of life (EQ-5D-5L), percentage of data captured to indicate adherence to the CGM and the acceptability of the intervention to participants, their consultees and carers (Theoretical Framework of Acceptability questionnaire).
International Clinical Trials Registry Platform (ID: ISRCTN 69024008).
在老年糖尿病患者中,药物过度处方现象普遍存在,这可能导致住院治疗并降低生活质量。此外,老年患者的糖尿病护理常常因多种相互作用的病症和认知障碍而变得复杂,从而使自我管理面临挑战。尽管有证据表明,在老年患者中减少用药剂量是安全的,但在此过程中尚无评估血糖范围的数据。
eDMED是一项为期12周的可行性研究,纳入了49名年龄≥65岁、患有2型糖尿病且居住在养老院的成年人。所有符合条件的参与者都将接受药物减量化和持续葡萄糖监测(CGM)。初级医疗保健专业人员(HCPs)将接受关于减量化算法和CGM的结构化培训,而养老院工作人员将接受关于糖尿病管理和CGM应用的定制教育,以确保安全有效地实施。
主要结果是通过CGM测量,在12周时达到血糖处于目标范围时间>50%且低于目标范围时间<1%这一综合指标的参与者百分比。次要结果包括高于和低于目标范围的时间趋势(通过高血糖或低血糖水平量化)、生活质量的变化(EQ-5D-5L)、为表明对CGM的依从性而采集的数据百分比以及参与者、其咨询者和护理人员对干预措施的可接受性(可接受性理论框架问卷)。
国际临床试验注册平台(ID:ISRCTN 69024008)。