Comparison of 3 Versus 6-Month Use of Professional Continuous Glucose Monitoring in the Treatment of Poorly Controlled, Non-Insulin Using T2DM Patients in a Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time Spent in Target Range
研究概览
简要总结
To determine whether 3-month versus 6-month professional CGM utilization improves time spent in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with insulin.
详细描述
Patients not receiving any insulin treatment with an HbA1c ≥ 7.5% before their scheduled primary care appointment will be invited to participate in the study and wear professional CGM for at least 3 days at either 3 intervals (baseline, 3-month and 6-month) or 2 intervals (baseline and 6-month). After removal, the downloaded report will provide quantitative data to determine the percent of time spent in the target range. The 6-month data will be analyzed to determine if frequency of professional CGM wear positively affects time spent in target range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years or older with a diagnosis of T2DM with a scheduled office visit with primary care provider within the next 4 weeks
- •Last 2 HbA1c values between 7.5 - 10% measured in the last 12 months
- •Treated with non-insulin therapies or therapeutic lifestyle changes
- •Never worn professional CGM or have not worn in last 12 months
- •Willing to perform requirements needed for professional CGM
排除标准
- •1. Current or previous treatment with any insulin within 3 months at baseline
研究组 & 干预措施
3-Month iPro2 Professional CGM
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
干预措施: iPro2 Professional CGM (Device)
6-Month iPro2 Professional CGM
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
干预措施: iPro2 Professional CGM (Device)
结局指标
主要结局
Time Spent in Target Range
时间窗: 6 Months
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
次要结局
未报告次要终点