An Open-label, Single-centre, Randomised, Cross-over Design Feasibility Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Comparison With Self-monitoring of Blood Glucose in Young Adults and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Sensor Glucose readings within target range
研究概览
简要总结
The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.
详细描述
This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 to 24 years with T1D will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 2 weeks of the first intervention period will be replaced.
Subjects will receive appropriate training in the use of real-time CGM. Subjects will have regular contact with the study team during the study.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of subject's responses in terms of daily diabetes management, diabetes distress and diabetes technology use and acceptance will also be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order.
入排标准
- 年龄范围
- 16 Years 至 297 Months（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 16 - 24 years old (inclusive)
- •Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- •HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
- •Treated with insulin pump or MDI
- •Has a Smart phone compatible with Dexcom G5 or similar
- •Willingness to wear study devices
- •Willing to follow study specific instructions
- •Literate in English
排除标准
- •Non-type 1 diabetes mellitus including those secondary to chronic disease
- •Any other physical or psychological disease likely to interfere with the normal conduct of the study
- •Untreated celiac disease or hypothyroidism
- •Current or planned users of real-time or flash (Libre) glucose monitoring sensors
- •Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc.
- •Regular use of acetaminophen
- •Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- •Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
- •Lack of reliable telephone facility for contact
- •Known or suspected allergy against insulin
- •Severe visual impairment
- •Severe hearing impairment
- •Subject not proficient in English
结局指标
主要结局
Sensor Glucose readings within target range
时间窗: 8 weeks
Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).
次要结局
- The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l(8 weeks)
- Sensor Glucose readings above target range(8 weeks)
- Average variation of glucose levels(8 weeks)
- Coefficient variation of glucose levels(8 weeks)
- The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)(8 weeks)
- Total daily insulin dose(8 weeks)
- AUC of glucose below 3.5mmol/l(8 weeks)
- HbA1c at 8 weeks(8 weeks)
- Standard deviation variation of glucose levels(8 weeks)
- Sensor Glucose readings below target range(8 weeks)