Beyond Education: A Hypoglycaemia Awareness Restoration Programme for People With Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 5
- 主要终点
- Difference in severe hypoglycaemia between study arms
研究概览
简要总结
Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe hypoglycaemia reduced when people are taught how to adjust their insulin around their life-styles through structured education but problematic hypoglycaemia may persist. Many people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit from conventional treatments to reduce hypoglycaemia. The investigators developed the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that combines revision of knowledge about hypoglycaemia avoidance with psychological therapies that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent severe hypoglycaemia.
The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an established educational intervention (Blood Glucose Awareness Training, BGAT) which has also been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic hypoglycaemia persisting despite otherwise optimised insulin self-management will be recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4 centres. The investigators will measure severe hypoglycaemia over two years following courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.
详细描述
This will be a group randomised trial of HARPdoc, a novel intervention for adults with type 1 diabetes (T1DM) and treatment-resistant impaired awareness of hypoglycaemia (IAH) and severe hypoglycaemia (SH), against Blood Glucose Awareness Training (BGAT), an existing educational programme that has been shown to reduce severe hypoglycaemia rates.
The hypothesis is that HARPdoc, because of its inclusion of psychological therapies addressing cognitive barriers to hypoglycaemia prevention, will be superior to BGAT training in reducing, and maintaining the reduction in, severe hypoglycaemia and in durably restoring awareness of hypoglycaemia in adults with type 1 diabetes whose problematic hypoglycaemia has persisted despite otherwise optimised diabetes self-management strategies. That optimised self-management is defined as a minimum of having attended a structured education programme in flexible intensive insulin therapy and be using its principles as a minimum.
HARPdoc and BGAT are both "talking therapies" of education plus, in the case of HARPdoc, a specific hypoglycaemia-focussed cognitive behavioural therapy (CBT), delivered to small groups (4 to 8 participants at a time) by established diabetes educators trained and supported to deliver each intervention.
Educators (nurses and dietitians) will be trained by the study clinical psychologists using existing curricula, to deliver EITHER HARPdoc OR BGAT. Educators delivering HARPdoc (2 per course), with its novel elements of hypoglycaemia specific cognitive behavioural therapy, will also receive weekly supervision from the study clinical psychologist, during the delivery of patient courses. BGAT educators (1 per course) will be able to seek support on an ad hoc basis.
Both BGAT and HARPdoc have their own course curricula and teaching aids. Participants will be recruited, will document their hypoglycaemia experience over a period of up to 12 months, and then be randomly allocated to a group in which they will either receive HARPdoc or BGAT . Follow up with be for two years with a planned analysis at 12 months. Documentation of SH will be monitored throughout using statistical process control and control mapping, to allow early termination of the study if one intervention is clearly outperforming the other, as assessed by an independent data monitoring committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in severe hypoglycaemia between study arms
时间窗: 12/24 months after randomisation
Difference in rate of severe hypoglycaemia events (number of events over preceding year), adjusted for baseline between the 2 arms at 12 and/or 24 months.
次要结局
- Changes in HbA1c > 0.3% and % participants with HbA1c <7%. between study arms(12/24 months after randomisation)
- Difference in rate of moderate hypoglycaemia between study arms(12/24 months after randomisation)
- The impact on hypoglycaemia without sacrificing diabetes control as reflected by the HbA1c(12/24 months after randomisation)
- Difference in the Gold score between study arms(12/24 months after randomisation)
- Difference in awareness of hypoglycaemia by modified Clarke score between study arms(12/24 months after randomisation)
- Changes in cognitions around hypoglycaemia using the Attitudes to Awareness between study arms(12/24 months after randomisation)
- Change in psychological health - anxiety and depression using HADS(12/24 months after randomisation)
- Change in psychological health - problems related to diabetes (PAID)(12/24 months after randomisation)
- Quality of Life - general(12 months after courses)
- Changes in cognitions using the Hypoglycaemia Fear Survey between study arms(12/24 months after randomisation)
- Changes in cognitions around hypoglycaemia using the Hyperglycaemia Avoidance between study arms(12/24 months after randomisation)