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
- 4
- 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
- •96 people, of whom 24 will be recruited in the US centre under their ethical regulations.
- •18 years or older
- •type 1 diabetes(1) for at least four years,
- •Experiencing problematic hypoglycaemia(2) for at least one year, despite structured education(3) in flexible insulin therapy and on-going optimal conventional care.
- •Current use of an appropriate (in the investigator's estimation) multiple daily insulin injection regimen or CSII (insulin pump) therapy(4)
- •Willingness to comply with study design, including willingness and ability to perform SMBG up to 4 times a day routinely
- •Ability to communicate in written and spoken English
- •Ability to give written informed consent.
- •Type 1 diabetes will be defined clinically, usually based on starting insulin for diabetes within one year of diagnosis and/or a history of diabetic ketoacidosis
- •Having Gold and Clarke scores of 4 or more and having had ≥ 1 episode/s of severe hypoglycaemia [events requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective action, because of impaired cognitive function, and which may include episodes that were not treated by another but included loss of consciousness or seizure] in the last 2 years and at least one since starting current treatment modality.
- •Structured education requires a programme with a curriculum, taught by trained educators, which covers insulin dose adjustment around carbohydrate counting and lifestyle issues, and a physiological 24 hr basal insulin replacement separate from meal insulin replacement) or as judged equivalent by the local investigator.
- •Participant should be using dose adjustment around carbohydrate counting and lifestyle issues, and an appropriate, separate basal replacement)
排除标准
- •People with type 2 diabetes, or type 1 diabetes and good hypoglycaemia awareness
- •People with type 1 diabetes and impaired hypoglycaemia awareness who have not attended structured education in flexible intensive insulin therapy, such as DAFNE, BERTIE, the Joslin course (DO IT) or as judged equivalent by the local investigator.
- •People not fluent in spoken English
- •Current pregnancy (5)
- •People with severe mental disorders (schizophrenia, manic depression, depressive psychosis, active suicidal ideation, learning disability, dementia, alcohol and substance dependence, personality disorders, eating disorder)(6).
- •Cognitive impairment independent of hypoglycaemia (e.g. clinical diagnosis of dementia(7), advanced Parkinson's disease, neurodegenerative disease)
- •Existence of co-morbid medical disease other than diabetes mellitus contributing to hypoglycaemia (e.g. inadequately treated Addison's disease or growth hormone deficiency or hypothyroidism; untreated coeliac disease; uncontrolled gastroparesis; end stage renal disease), which must have been checked since the onset of problematic hypoglycaemia.
- •(5) Participants who continue to experience severe hypoglycaemia episodes 6 months after they have stopped breastfeeding may be included in the trial.
- •(6) "Manic depression" covers conditions such as bi-polar disorder. Pre-existing depression that is on-going but, in the opinion of the investigator, stable and not a barrier to potential benefit from BGAT or HAPRdoc is not an exclusion criterion. Exclusion of individuals with a personality disorder includes those with current or previous clinical diagnosis AND current or previous mental health care for that disorder
- •(7) Dementia would cover either an existing diagnosis or a Mini Mental State Examination [MMSE]) score of less than
- •Participants who have expressed interest in the study, have consented, and have impaired awareness of hypoglycaemia but do not otherwise meet the inclusion criteria due to low number of SH episodes may be included in the HARPdoc educational course as 'fillers' if space is available. These patients will not be randomised, nor entered into the study database. However, they may be asked to complete the open baseline, 12 and 24-month data collection if they agree to do so.
研究组 & 干预措施
HARPdoc courses
Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) - a combination of structured education around hypoglycaemia recognition, avoidance and treatment combined with hypoglycaemia-focussed cognitive behavioural therapy, delivered by diabetes educators, supported by a clinical psychologist, to small groups of eligible adults.
干预措施: HARPdoc courses (Behavioral)
BGAT courses
Blood Glucose Awareness Training is an existing psycho-educational program which coaches adults with type 1 diabetes better to predict and recognise extremes of plasma glucose - hyper- and hypo-glycaemia. It has been shown to reduce severe hypoglycaemia rates.
干预措施: BGAT courses (Behavioral)
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 cognitions using the Hypoglycaemia Fear Survey between study arms(12/24 months after randomisation)
- 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 around hypoglycaemia using the Hyperglycaemia Avoidance between study arms(12/24 months after randomisation)