Time-in-Range (TIR), a Novel Continuous Glucose Monitoring (CGM) Based Measure, to Improve Risk Stratification of Microvascular Complications in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Presence of Diabetes Retinopathy
研究概览
简要总结
The goal of this observational study is to learn about the role of Time-in-Range to stratify the risk of micro vascular complications in adults with type 2 diabetes. The main questions it aims to answer are:
- Is a lower Time-in-Range associated with a higher risk of diabetes microvascular complications, independent of HbA1c?
- Is Time-in-Range lower among sulfonylurea and premixed insulin therapy users compared to non-sulfonylurea and non-premixed insulin therapy users, respectively.
详细描述
Methods/Approach
Participants: Investigators aim to recruit a maximum of 500 adults with type 2 diabetes on medical therapy with an HbA1c between 6-12%. Pregnant women, people undergoing active cancer therapies, people taking oral or injectable steroids and those with chronic kidney disease on dialysis will be excluded as the glycemic profile and the pathology in these patients are significantly different from a typical adult with type 2 diabetes. Stratified recruitment will aim to achieve a minimum number in the four major therapy classes to ensure a heterogeneous and representative sample.
- Oral drugs ± basal insulin not using sulfonylureas (50-200)
- Oral drugs ± basal insulin using sulfonylureas (50-200)
- Insulin replacement using premixed insulin therapy (50-200)
- Insulin replacement using basal-bolus insulin therapy (50-200)
Baseline assessment
At baseline, detailed medical history and anthropometry will be collected from the participants, and participants will have their HbA1c measured, and glycaemia characterized using a blinded CGM. Blood and urine (if required) will be collected for HbA1c and Albumin-creatinine ratio, respectively. HbA1c test results, if available within 6 weeks and Urine Microalbumin-Creatinine Ratio, if available within 6 months from the date of recruitment will be deemed sufficient and no further tests will be done as part of the research. Neuropathy will be assessed by a non-invasive foot exam with a 10g monofilament and neurothesiometer.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes,
- •Age >= 21 years,
- •Ability to provide informed consent,
- •HbA1c done within 6 months of recruitment between 6-12%
排除标准
- •Undergoing active chemotherapy or immunotherapy for cancer
- •Currently taking oral or injectable steroids
- •Chronic kidney disease on dialysis
- •Women who are pregnant or breastfeeding
结局指标
主要结局
Presence of Diabetes Retinopathy
时间窗: 10 years
Based on Fundal Photography grading
Presence of Diabetes Neuropathy
时间窗: 10 years
Based on 10g monofilament foot examination
Presence of Diabetes Nephropathy
时间窗: 10 years
Urine microalbumin-creatinine ratio in mg/g
次要结局
- Continuous glucose monitoring derived glycemic variables(14 days)
- Severity of corneal neuropathy(10 years)
- Severity of diabetes peripheral neuropathy(10 years)
- Severity of Retinal degenerative changes(10 years)