Hypoglycemia Requiring Emergency Services Intervention: Patient Characteristics, Outcome and Cardiovascular Risk Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- All cause mortality at study endpoint with each participant having a minimum follow up of 12 months and the final analysis of data being done 58 months after the first participant was recruited (this is study endpoint.)
研究概览
简要总结
Patients who suffer hypoglycaemia in the community requiring the services of an ambulance are known to have a high short term mortality based on previous work. What is not known is the demographics of this group and also what the cause of death was for individuals whom unfortunately passed away in the time following ambulance callout. Importantly, studies looking at interventions to reduce poor outcomes in this group are lacking. The investigators conducted a pilot trial with the main goals to:
- Characterise this group in more detail and ascertain what was recorded as cause of death in those whom passed away in the months/years following community hypoglycaemia
- Ascertain if a simple nurse led intervention, focusing on educating participants on avoidance of hypoglycaemia, could improve outcome.
详细描述
Previous studies, including our own, have shown that in those with diabetes, severe hypoglycaemia (defined as requiring the assistance of emergency ambulance in the community) carries with it a high mortality in the immediate months/short years following the event. What isn't known is what this group of patients dies of and what the demographics of this group may be. This is important as this is a vulnerable patient group in whom few interventions to reduce this excess mortality have been trialled.
Through a collaboration with a local ambulance service, the hospital diabetes research team set out to recruit participants to a small, pilot, randomized controlled trial to try and ascertain more about the demographics of this group, follow them up in a longitudinal fashion and report on their causes of death using information recorded on death certificates (a statutory requirement in the UK). Additionally the investigators sought to provide pilot data on whether a structured nurse led intervention programme could reduce risk.
The local ambulance service contacted the research team, with patient consent, once they had been called to treat a patient with diabetes whom had severe hypoglycaemia. Within 7 days a research nurse approached those whom had given consent to invite them to take part in a clinical trial. Full eligibility criteria are available elsewhere in this document. Following this, groups were split in the following way:
- Intensive group - participants were randomized to receive a structured nurse led intervention aiming to educate them on the treatment of and how to avoid hypoglycaemia.
- Standard group - participants were randomized to continue on their current diabetes treatment and were returned to their standard diabetes care provider.
- Observational group - participants were happy to have a baseline visit, and for their case to reviewed using electronic records moving forward, but they did not wish to be randomized to an intervention.
All three groups had baseline data collected including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the intervention 9a nurse led education programme) it was not possible to mask participant or trial team to the intervention
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
- •Diabetes mellitus Can provide written informed consent
排除标准
- •Hypoglycaemia from cause not related to diabetes mellitus
研究组 & 干预措施
Interventional/intensive
Participants received a structured nurse led education programme surrounding hypoglycaemia. They were encouraged to use self monitoring of blood glucose (SMBG) and had their diabetes medications adjusted according to this. They also received information on how to avoid hypoglycaemia (including the effects of diet, exercise, alcohol and their medications) and how to treat hypoglycaemia should it occur.
干预措施: Structured nurse led intervention programme (Behavioral)
Standard
Participants returned to their standard diabetes care provider with no intervention.
干预措施: Standard care (Other)
Observational
Participants were happy to have baseline characteristics collected and be followed up using electronic records in a longitudinal fashion but did not wish to be randomized. The observational and standard groups therefore received the same diabetes care.
结局指标
主要结局
All cause mortality at study endpoint with each participant having a minimum follow up of 12 months and the final analysis of data being done 58 months after the first participant was recruited (this is study endpoint.)
时间窗: Through study endpoint, which was 58 months following the recruitment of the first participant and 12 months following the recruitment of the last participant.
Electronic review of participants records to ascertain if they had passed away during the study
次要结局
- Assessment of differences in mortality rate between type 1 and type 2 diabetes participants(Study endpoint (12 months following recruitment of last participant.))
- All cause mortality at 12 months from recruitment.(12 months)
- Analyse cause of death at study endpoint (12 months following recruitment of last participant).(Study end point defined as 12 months following recruitment of last participant (approximately 40 months from start of study).)
研究者
Ramzi Ajjan
Professor of metabolic medicine
University of Leeds