Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- HbA1c Variation
研究概览
简要总结
To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.
详细描述
This is a parallel randomized controlled trial. Eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for CGM, or (2) the control group who will follow their current standard finger-prick protocol via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and Clarity mobile apps for data capture, whereas the standard of care group will use the Contour Next mobile app for their respective readings.
The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in this study are FDA approved and commercially available.
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
盲法说明
Patients were either randomized to the Dexcom G6 Device or the Contour NextOne a Standard of Care glucometer. Both subjects knew what they received after they were randomized.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%
- •Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider)
- •Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age
排除标准
- •Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician)
- •Patients that are not treated within the four Reimagine Primary Care clinics
- •Patients less than 18 years of age, and 81 years of age and older
- •Patients with a diagnosis of dementia
- •If the patient is currently using a Continuous Glucose Monitor
- •Patients with previous hospitalization for hypoglycemia within the last 18 months
- •No access to a mobile phone to download the Dexcom or Contour Next applications
- •Patients who are pregnant or planning to become pregnant over the course of their six-month participation
结局指标
主要结局
HbA1c Variation
时间窗: 6 months
Coefficient of variation in HbA1c levels before, during and end of study completion.
HbA1c Range
时间窗: 6 months
Variation of range in HbA1c levels before, during and end of study completion.
次要结局
- Current Diabetes Standards(6 months)
- Behavioral Changes(6 months)
- Hypoglycemic Events(6 months)
- Healthcare Utilization(6 months)
- Glycemic Variability(6 months)
- Emergency Room Visits(6 months)
- Healthcare Cost(6 months)