Frequency of Nocturnal Hypoglycaemia in Adults With Insulin-treated Diabetes and Adrenal Failure Using Prednisolone or Hydrocortisone: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time spent in hypoglycaemia
研究概览
简要总结
The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone.
Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens.
The study has three aims:
- To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes
- To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone.
- To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.
The study will compare this information with results in people who have AI without diabetes.
Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.
详细描述
PURPOSE OF THE STUDY
The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars throughout the day and night. This study will assess how often hypoglycaemia occurs, especially at night, and whether the type of steroid tablet people take affects how often hypoglycaemia happens.
STUDY AIMS
- To measure how often low blood sugars occur at night in people with both AI and insulin-treated diabetes using CGM, and in people without diabetes who are matched in age, sex and steroid replacement (hydrocortisone or prednisolone).
- To compare the frequency of low blood sugars in people taking prednisolone for their AI versus those taking hydrocortisone.
- To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.
STUDY DESIGN
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •for test group:
- •Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year.
- •Adults aged above 18 years
- •for matched control group:
- •Diabetes mellitus excluded on baseline blood review
- •Adults aged above 18 years
排除标准
- •Measured eGFR ≤ 30
- •Acute illness
- •Abnormal thyroid function
- •Admission to hospital
- •Pregnant or planning pregnancy
- •Breastfeeding
- •Enrolled in other clinical trials, except at the discretion of the chief investigator
- •Have active malignancy or under investigation for malignancy
- •Severe visual impairment
- •Reduced manual dexterity
- •Unable to participate due to other factors, as assessed by the Chief Investigators
结局指标
主要结局
Time spent in hypoglycaemia
时间窗: 30 days
Percentage time spent in hypoglycaemia (glucose levels \< 3.0mmol/L, 55mg/dL). Glucose levels will be measured by a continuous glucose monitoring device (CGM).
次要结局
- Hypoglycaemic excursions(30 days)
- Gold questionnaire score(Baseline)
- Hospital Anxiety and Depression (HADS) Score(Baseline)
- Hypoglycaemia Fear Survey-II (HFS-II) score(Baseline)
- Time spent in target glucose levels(30 days)
- Time spent in hyperglycaemia(30 days)
- Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)(30 days)