FreeSTyle LibRe and hospitAl Admissions, morTality and qUality of Life in High Risk Type 2 diabeteS Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mortality at 2 years
研究概览
简要总结
This study aims to investigate the utility of a combination of structured nurse led intervention and the use of Freestyle libre in adults with type 2 diabetes who have suffered an episode of severe hypoglycaemia in terms of mortality, unscheduled healthcare contacts and quality of life.
详细描述
It is increasingly recognised that hypoglycaemia carries risk to individuals with all forms of diabetes. Research has shown high rate of mortality in those with type 2 diabetes following an episode of severe hypoglycaemia and a previous pilot trial conducted in the UK suggested that this could be improved by a structured nurse led intervention aimed at modifying glycemic therapy to avoid hypoglycaemia, instigating regular blood glucose monitoring and providing education to participants on common triggers for hypoglycaemia and how to avoid them.
In this trial, the investigators will randomise individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia requiring emergency service call out to two arms. One arm will receive standard of care/treatment as usual and the other will receive a structured nurse led intervention as well as the use of a flash glucose monitoring system, Freestyle libre.
Active participation in the trial for both arms will be a total of twelve months (with the main intervention months 0-6.) Participants electronic records will be analysed for death and unscheduled healthcare contacts for a total of two years after recruitment.
The primary outcome measure is mortality between groups. Secondary outcomes include the use of estimated HbA1c (a variable produced by the freestyle libre device) compared to laboratory HbA1c, quality of life measures, effects on glycemic control and the number of unscheduled healthcare contacts.
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
- None
盲法说明
Unable to mask participants and trailists due to study design.
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
- •Aged >18
- •Confirmed diagnosis of type 2 diabetes
- •Suffered an episode of severe hypoglycaemia requiring ambulance call out
- •Able to provide informed written consent
排除标准
- •A form of diabetes mellitus which is not type 2 or the diagnosis is uncertain
- •Currently pregnant
- •Dialysis dependent renal failure
- •Unable to provide informed written consent
研究组 & 干预措施
Standard of care
Participants are returned to the care of their usual diabetes care provider following randomisation. They will donate blood and urine samples as well as completing diabetes specific questionnaires at 0 and 6 months. They will also wear a blinded glucose sensor (freestyle Libre PRO) for a two week period at month 6.
Intervention arm
Participants will be randomised at baseline. They will provide blood and urine samples at months 0 and 6 as well as fill in diabetes specific questionnaires. They will receive education surrounding hypoglycaemia at baseline from a diabetes specialist nurse. They will wear a freestyle libre device which is changed every two weeks for a period of 6 months. At weeks 2,4,12 and 24 they will have their diabetes medication adjusted by the diabetes specialist nurse/diabetes doctor according to their blood glucose profiles, analysed from the data generated by freestyle libre.
干预措施: Freestyle libre (Device)
Intervention arm
Participants will be randomised at baseline. They will provide blood and urine samples at months 0 and 6 as well as fill in diabetes specific questionnaires. They will receive education surrounding hypoglycaemia at baseline from a diabetes specialist nurse. They will wear a freestyle libre device which is changed every two weeks for a period of 6 months. At weeks 2,4,12 and 24 they will have their diabetes medication adjusted by the diabetes specialist nurse/diabetes doctor according to their blood glucose profiles, analysed from the data generated by freestyle libre.
干预措施: Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification (Other)
结局指标
主要结局
Mortality at 2 years
时间窗: 2 years
Rates of death between groups at 2 years
次要结局
- All-cause mortality at 1 year(12 months)
- Cardiovascular mortality at 2 years(2 years)
- Cardiovascular mortality at 1 year(1 year)
- Change from baseline in HbA1c(6 months)
- Scores from treatment satisfaction scale (DTSQc)(Tested at 0 and 6 months)
- Number of unscheduled healthcare contacts(2 years after randomisation)
- Comparison between estimated HbA1c and laboratory HbA1c(6 months)
- Scores from Diabetes distress scale(Tested at 0 and 6 months)
- Scores from GOLD score(Tested at 0 and 6 months)
- Scores from diabetes quality of life scale (DQOL)(Tested at 0 and 6 months)
研究者
Ramzi Ajjan
Professor of metabolic medicine
University of Leeds