An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
研究概览
简要总结
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.
详细描述
The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys.
Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Type 2 diabetes
- •Age ≥18 years old
- •Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days
- •Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol
- •Resident of the US
- •English speaking/reading
- •Access to email/phone
排除标准
- 未提供
结局指标
主要结局
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
时间窗: Up to 3 months
Number of DKA events and event outcomes. DKA events are defined as hospitalization with documentation of arterial blood pH \<7.30 or venous pH \<7.24 or serum bicarbonate (or CO2) \<15.
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
时间窗: Up to 3 months
Number of severe hypoglycemic events and event outcomes. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
Measure of Loop Safety by Self-Report of Hospitalization Events
时间窗: Up to 3 months
Number of hospitalizations
次要结局
未报告次要终点