Garmin PACT (Physical Activity Tracking)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Moderate to Vigorous Physical Activity (MVPA) Amount
研究概览
简要总结
The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are:
- Does the Garmin Vivosmart increase physical activity (PA)?
- Does the Garmin Vivosmart improve T1D status
Participants will:
- Wear the Garmin Vivosmart (4 or higher) for a year
- Complete surveys at the beginning, middle and end of participation asking about your T1D, T1D management, and PA
- Parents of children will also complete similar surveys about T1D
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 8-21 years of age and/or parent of participant aged 8-17 years of age
- •Participants diagnosed with T1D greater than 6 months ago
- •Participants must be patients at the Children's Mercy Kansas City network
排除标准
- •Participants who do not meet age criteria above
- •Participants who do not have T1D
- •Participants who are unwilling to wear the device for at least 6 months
结局指标
主要结局
Moderate to Vigorous Physical Activity (MVPA) Amount
时间窗: Up to 365 days +- 30 days
Minutes per Day of MVPA
Predicted Change
时间窗: 365 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Diabetic Ketoacidosis (DKA) Admission
时间窗: 365 +-30 days
Rate of hospitalization for diabetic ketoacidosis
Minutes of Sleep Per Day
时间窗: Up to 365 days +- 30 days
Minutes of Sleep per Day
Change in Time in Range
时间窗: Over 90, 180, and 365 +- 30 days
Time where blood glucose is in an appropriate range (and other glucose measurements)
次要结局
- Self Reported Physical Activity(12 months)
- Self Reported T1D Management(12 months)
- Change in Self Reported Physical Activity Levels(Between 0, 6, and 12 months)
- Change in How Participants Feel About Episodes of Hypoglycemia(Between 0, 6, and 12 months)
- Change in How Parents Feel About Episodes of Hypoglycemia in Their Children(Between 0, 6, and 12 months)