The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 8
- 主要终点
- Difference in Change in A1c (%) between continuous use of CGM and control
研究概览
简要总结
The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
详细描述
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
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
入排标准
- 年龄范围
- 8 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes for at least 12 months
- •HbA1c must be 8.1% or above at study entry
- •Intensive Insulin Therapy 3 months prior to study entry
排除标准
- •Impaired hearing or vision (must see screens and hear alarms)
- •Unable to comply with protocol
- •Chronic debilitating or psychiatric disturbances
结局指标
主要结局
Difference in Change in A1c (%) between continuous use of CGM and control
时间窗: 12 weeks
次要结局
- Difference in change in A1c (%) between biweekly use of CGM and control(12 weeks)
- Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM(12 weeks)