The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Differences in blood glucose
研究概览
简要总结
This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.
详细描述
The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a "wash-in" phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age 18 or older
- •Newly diagnosed with pre-diabetes (within the previous 6 months) with a FPG of > or = 110-125mg/dl or an A1c > or = 6% - 6.4%
- •Able to independently measure and read finger stick blood glucose levels
- •Willing to wear the CGM device for up to 12 weeks during the study period
- •Willing to test blood sugar by fingerstick twice per day while wearing the CGM
- •DEERS eligible
排除标准
- •Using medication for pre-diabetes
- •Women who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method; all female subjects will undergo pregnancy testing via a serum HcG with their initial blood testing.
- •Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study.
- •Active Duty service members likely to be deployed during the 18-month study period.
结局指标
主要结局
Differences in blood glucose
时间窗: baseline, 18 months
Changes in A1c and fasting blood glucose over time and between the intervention and control groups.
次要结局
- Differences in lipids.(baseline, 18 months)
- Impact of lifestyle changes(baseline, 18 months)
- Differences in blood pressure.(baseline, 18 months)
- Changes in medication use(baseline, 18 months)
- Differences in weight(baseline, 18 months)
- Changes in Glucose dynamics(baseline, 18 months)
研究者
Alicia L. Warnock
Director, Diabetes Institute
Walter Reed National Military Medical Center