Onduo Virtual Diabetes Clinic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Mean Change in Hemoglobin A1c
研究概览
简要总结
This is a prospective, single arm study designed to evaluate the change in hemoglobin A1c after 4 months of participation in the Onduo Virtual Diabetes Clinic (VDC) in individuals with Type 2 diabetes and suboptimal glycemic control.
详细描述
The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services accessed via a software application (Onduo App).
Eligible subjects are asked to use the Onduo App and commercially available FDA-regulated medical devices and non-medical devices, for up to 4 months.
Subjects receive a continuous glucose monitor (CGM) and are asked to use the device for up to 6 wear cycles of 10 days each.
Subjects are scheduled for a medical review via a face-to-face telemedicine consultation with a VDC Physician.
Subjects may have their diabetes medications changed by a VDC Physician following their telemedicine visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and Female; 18 years of age or older
- •Confirmed diagnosis of Type 2 diabetes mellitus
- •Willing to use CGM and BGM
- •A1c result ≥8.0% and ≤12.0%
- •Receive their diabetes care from Premier Medical Associates or the Palo Alto Medical Foundation
- •Own a Smartphone with a data plan and be the primary user of that smartphone
- •Smartphone must use a supported Android OS or iOS
排除标准
- •Pregnant or breastfeeding
- •Use of an insulin pump
- •Any condition or situation that the Sponsor or Investigator determines as inappropriate for study inclusion
结局指标
主要结局
Mean Change in Hemoglobin A1c
时间窗: 4 Months
Mean change in hemoglobin A1c from enrollment to 4 months
次要结局
- Time to First Change in Diabetes Medication or Dosage From Enrollment(4 Months)
- Mean Change in A1c(4 Months)
- Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period.(4 Months)
- Change in Weight From Enrollment(4 Months)
- Change in Mean Glucose From the First Wear Period Versus the Final Wear Period.(4 Months)
- Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period.(4 Months)