Diabetes Department, Denmark Hill Campus, King's College London Faculty of Life Sciences and Medicine, London, UK.
Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.
BMJ Open. 2019 Jun 16;9(6):e030356. doi: 10.1136/bmjopen-2019-030356.
Severe hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence.
A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol.
The protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups.
NCY02940873; Pre-results.
严重低血糖（SH）是 1 型糖尿病（T1DM）胰岛素治疗最可怕的急性并发症，当血糖降至无法维持大脑功能的水平时就会发生低血糖。10%的 T1DM 患者贡献了近 70%的所有发作，而低血糖意识受损（IAH）是一个主要的危险因素。IAH 患者可能对降低 SH 的常规方法产生抗药性，并且有证据表明存在对低血糖回避的认知障碍。本文描述了 Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care（HARPdoc）研究的方案，这是一项试验，旨在评估一种新的干预措施对低血糖体验的影响，该措施针对低血糖回避的认知障碍，与国家卫生与保健卓越研究所（National Institute of Health and Care Excellence）推荐的现有对照干预措施进行比较。
一项随机平行双臂试验，对 96 名 T1DM 且存在尽管接受了教育且有或没有使用技术，但仍持续存在问题性低血糖的成年人进行两种团体治疗：HARPdoc 与血糖意识训练。该试验在四个提供 T1DM 专业服务的中心进行。主要结局将是在随机分组后 12 个月和/或 24 个月的 SH 发生率。次要结局包括需要静脉治疗、涉及无意识或需要紧急服务的 SH 发生率；低血糖意识状态、整体糖尿病控制和生活质量测量。计划进行一项平行研究作为实施研究，以评估干预措施的实施情况以及实施对临床效果的影响，该研究有自己的方案。
该方案已获得伦敦德威研究伦理委员会、卫生研究管理局、英国国家卫生服务机构研发和美国 Joslin 糖尿病中心机构审查委员会的批准。研究结果将通过同行评议的出版物和会议演讲，包括用户群体，向研究参与者进行传播。
NCY02940873；预结果。
