An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetes Mellitus, Type 1
- 发起方
- Jaeb Center for Health Research
- 入组人数
- 1212
- 试验地点
- 1
- 主要终点
- Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
- 状态
- 已完成
- 最后更新
- 5年前
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 Loop DIY automated insulin delivery system.
详细描述
The study will include both adults and youth in the United States, with a recruitment goal of at least 300-1,250 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 psychosocial and user experience/treatment satisfaction surveys. Online forms will allow participants to report weekly device issues and serious adverse events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General data updates will be obtained after three, six, and 12 months (and every six months thereafter if study participation continues). A fingerstick blood sample will be collected for HbA1c measurement after three months for cohort A and after six and 12 months for both cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be completed after six and 12 months; new users also will complete questionnaires after 3 months. Virtual focus groups will be completed within the first three months of starting Loop and at 12 months.
研究者
入排标准
入选标准
- •Type 1 diabetes
- •Currently have, or have ordered, the hardware devices necessary to use Loop
- •Currently use Loop or have plans to start using Loop for insulin delivery
- •Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data and complete questionnaires that are part of the protocol
- •Resident of U.S.
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: 6 Months
Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
时间窗: 6 Months
Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. 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: 6 Months
Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.
次要结局
- Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events(12 Months)
- Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events(12 Months)
- Measure of Loop Safety by Self-Report of Hospitalization Events(12 Months)