Improving Glucose Control and Self-Management in Adults With Type 2 Diabetes From Health Disparate Groups Using Continuous Glucose Monitoring and Education Support
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Glycemic control
研究概览
简要总结
The study is a longitudinal single-arm prospective study design. Adult patients who are African American or Hispanic with type 2 diabetes mellitus will be recruited to participate in this study. The goal of the study is to determine if the use of a continuous glucose monitoring system will improve diabetes management in persons from health disparity background.
The subjects will be closely monitored for the first 3 months as they utilize the continuous glucose monitor and engage in diabetes education classes. They will then be followed for an additional 3 months to determine if they are able to maintain the same glucose control as experienced for the initial 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Adult subjects with type 2 diabetes mellitus ≥18 years
- •African-American or Hispanic
- •with A1c ≥8% to ≤12%
排除标准
- •Patients with type 1 diabetes,
- •pregnant,
- •End-Stage Renal Disease,
- •recent use of any CGM within the last 12 months,
- •on steroid therapy and history of adhesive allergy.
结局指标
主要结局
Glycemic control
时间窗: At 6 months post enrollment
To investigate the effect of the Continuous Glucose Monitoring (CGM) device and educational support on the Glycemic control. Glycemic control will be measured based on the percent time that glucose is on target vs off target. On target is within the normal range of 70-180 mg/dL. Off target includes: \<54 mg/dL (critical low glucose); \< 70 mg/dL (low glucose); \>180 mg/dL (high glucose); and \>250 mg/dL (very high). The range at 24 weeks post enrollment will be compared to the baseline data that will be collected after the first 14 days (2 weeks).
A1c - Marker of overall glucose control
时间窗: At 6 months post enrollment
A1c levels measured at 24 weeks post enrollment will be compared to the baseline A1c level (measured at enrollment).
次要结局
- ER visit(For the 3 months post enrollment)
- Blood pressure(At 3 months post enrollment)
- Weight(At 3 months post enrollment)
- BMI(At 3 months post enrollment)
- Hospital admissions(For the 3 months post enrollment)
- Glycemic control - Episodes of hypoglycemia(For the 3 months post enrollment)
- Diabetes self-care(At 3 months post enrollment)
- Diabetes distress(At 3 months post enrollment)
- Satisfaction with CGM device(At 3 months post enrollment)
- Diabetes knowledge(At 3 months post enrollment)