How Common is Hypoglycaemia in Older People With Diabetes Who Have Falls, Dizziness or Other Symptoms Suggestive of Hypoglycaemia? A Continuous Glucose Monitoring Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Proportion of Participants With Captured Hypoglycaemia
研究概览
简要总结
The purpose of this study is to use 24 hour continuous glucose monitoring in older patients with diabetes who present with symptoms of falls, or dizziness, or confusion, that may indicate hypoglycaemia.
详细描述
Background and study aims Patients with diabetes can be treated with medications (such as insulin or sulfonylureas) that can lower the sugar levels too much (hypos). A hypo means that the brain does not get enough energy. A person can become confused, dizzy, pass out, and/or have a fall.
Older people with diabetes often seek treatment in hospital for symptoms such as falls, dizziness or feeling muddled. Health care professionals will order tests to investigate the possible causes for the fall, being muddled or dizzy, which can include a review of medications, checking blood pressures and the heart.
However, it has previously been difficult to obtain 24-hour blood sugar monitoring in older people with diabetes to check if hypos could be an important contributing factor to their falls and dizzy spells.
Continuous Glucose Monitoring (CGM) allows non-stop monitoring with a sensor that sits just under the skin. This sends sugar readings to a smartphone every few minutes (via Bluetooth) for 10 days. This enables full evaluation of the amount of time a person's sugar is in the target range, and the time in the low/high ranges. Medical research with CGM has revealed that some older people are suffering from substantial periods of hypos that they are not aware of.
During this study, older people with diabetes will be asked to wear a CGM device for 10 days to investigate possibility of hypos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •75 years and older with diabetes
- •Treated with glucose-medications which carry a high risk of hypoglycaemia (sulfonylureas and/or insulin)
- •Presenting to hospital with a fall and/or symptoms suggestive of unrecognised hypoglycaemia (such as dizziness, feeling muddled).
排除标准
- •Treatment with metformin alone
- •Lack of capacity,
- •Not willing to participate,
- •Terminal illness (less than one-year life expectancy).
- •Evidence of bruising, bleeding, cellulitis and/or skin tears on the upper arms or abdomen.
结局指标
主要结局
Proportion of Participants With Captured Hypoglycaemia
时间窗: 10 days
Number of patients who experienced more than 15 minutes of hypoglycaemia within the 10-day sensor lifespan and data capture period.
次要结局
- Overall Time in Range (Average)(10 days)
- Emergency Department Re-attendances and/or Hospital Re-admissions for Falls, Fractures, Heart Attacks, Ischaemic Strokes and Death Within 30 Days(30 days)