Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 8
- 主要终点
- Impact on time above 180 mg/dL
研究概览
简要总结
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.
详细描述
Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.
The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Subject must be at least 18 years of age.
- •Subject has been diagnosed with type 2 diabetes.
- •HbA1c greater than or equal to 7.5% and less than or equal to 12%
- •Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
- •Subject owns a compatible smartphone
- •Subject agrees to a 3-month period of no diabetes medication changes.
- •Subject is willing to make diet and lifestyle changes in response to education and glucose data
排除标准
- •Subject is currently on insulin therapy or sulfonylurea-based medications.
- •Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- •Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
- •Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
结局指标
主要结局
Impact on time above 180 mg/dL
时间窗: Three (3) months
To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL
次要结局
未报告次要终点