Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
研究概览
简要总结
This study is observational, designed to collect real world use and safety data for those using the Bigfoot Unity Diabetes Management System for 12 months. Participants will be those with a prescription to use the Bigfoot Unity System. Medical practices prescribing Bigfoot Unity and Sponsor representatives will provide information about the study to current users and individuals considering initiation of the Bigfoot Unity System. During the course of the study, participants will be asked to use the Bigfoot Unity System in accordance with the prescription provided by their healthcare professional (HCP).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes diagnosis
- •HCP-prescribed, registered Bigfoot Unity users who have used the Bigfoot Unity System 2 weeks or less
- •Age 12 years or older at time of electronic informed consent
- •Using both long-acting and rapid-acting insulins that are compatible for use with the Bigfoot Unity System
- •Using long-acting insulin no more than 1 time per day
- •Must have baseline HbA1c collected within 90 days prior to starting the Bigfoot Unity System
- •Able to read and understand English
- •Participant or legally authorized representative for minors has the capacity to provide electronic informed consent
- •Resident of the United States
- •Persons who are using a phone that is compatible with Bigfoot Unity and not shared with a family member or a caregiver
排除标准
- •Females who are pregnant or intending to become pregnant during participation in the study
- •Persons with implantable medical devices such as pacemakers
- •Persons on dialysis or other serious medical conditions that would impact the ability to use the device or manage their diabetes
- •Persons taking or expected to be taking >500mg Vitamin C supplements on routine basis
- •Persons employed by the Sponsor or JCHR
结局指标
主要结局
Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive
时间窗: 12 months
Glucose management indicator
时间窗: 12 months
Change from baseline in HbA1c
时间窗: 12 months
Glycated hemoglobin
Change from baseline in Insulin Delivery Satisfaction Survey
时间窗: 12 months
Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better.
System Usability Scale
时间窗: 12 months
Measures the usability of a system; scale is 0 to 100, higher scores are better.
Percent time Sensor in hypoglycemia
时间窗: 12 months
Will evaluate Sensor below 70 mg/dL and below 54 mg/dL
Percent time Sensor in hyperglycemia
时间窗: 12 months
Will evaluate Sensor above 180 mg/dL and above 250 mg/dL
Change from baseline in Diabetes Distress Scale
时间窗: 12 months
Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse.
Change from baseline in Hypoglycemia Confidence Scale
时间窗: 12 months
Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse.
次要结局
未报告次要终点