School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK.
School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK.
Res Social Adm Pharm. 2021 May;17(5):885-893. doi: 10.1016/j.sapharm.2020.07.012. Epub 2020 Jul 29.
Hypoglycaemia is one of the most serious adverse effects of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in studies that evaluate the impact of such type of interventions on hypoglycaemia risk in elderly patients with type 2 diabetes. The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
and analysis: This study is an open-label, parallel controlled randomised trial, which will be conducted in the outpatient clinics at the largest referral hospital in the north of Jordan. Participants who are elderly (age ≥ 65 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications will be randomly assigned to intervention (SUGAR Handshake) and control (usual care) groups. The SUGAR Handshake participants will have an interactive, individualised, medications-focused counselling session reinforced with a pictogram and a phone call at week six of enrolment. The primary outcome measure is the frequency of total hypoglycaemic events within 12 weeks of follow up. Secondary outcomes include the frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack. We will also conduct a nested qualitative study for process evaluation.
The Human Research Ethics Committee of the University of Lincoln and the Institutional Review Board of King Abdullah University Hospital approved this protocol. The findings of this study will be presented in international conferences and published in a peer-reviewed journal.
The study protocol has been registered with ClinicalTrials.gov, NCT04081766.
低血糖是糖尿病治疗中最严重的不良反应之一。老年人发生低血糖的风险最高。有几项研究已经证实了教育干预对实现血糖控制和其他临床结果的重要积极作用，然而，仍然缺乏评估这种干预类型对 2 型糖尿病老年患者低血糖风险影响的研究。本研究旨在评估药剂师主导的患者咨询对减少老年 2 型糖尿病患者低血糖发作的效果。
这是一项开放标签、平行对照的随机试验，将在约旦北部最大的转诊医院的门诊进行。参与者为老年人（年龄≥65 岁）、诊断为 2 型糖尿病、并服用胰岛素、磺酰脲类或任何三种抗糖尿病药物，将被随机分配到干预（SUGAR Handshake）和对照组（常规护理）。SUGAR Handshake 参与者将在入组后第 6 周进行一次互动式、个性化、以药物为重点的咨询，同时辅以图表和电话随访。主要结局指标是随访 12 周内总低血糖事件的发生频率。次要结局包括无症状、有症状和严重低血糖事件的发生频率、低血糖发生率以及首次低血糖发作的时间。我们还将进行一项嵌套的定性研究以进行过程评估。
林肯大学人类研究伦理委员会和阿卜杜拉国王大学医院机构审查委员会批准了该方案。本研究的结果将在国际会议上展示，并发表在同行评议的期刊上。
该研究方案已在 ClinicalTrials.gov 注册，注册号为 NCT04081766。
