Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
- •Low exercise levels
- •Smartphone ownership
- •English literacy
- •Under regular care by a healthcare provider
- •Home Broadband wireless Internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads)
排除标准
- •Diabetic ketoacidosis not clearly related to pump site failure in past 6 months
- •>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months
- •A1c ≥10.0%
- •Resting blood pressure >160mmHg systolic or >100 mmHg diastolic
- •Myocardial infarction or angina in past 12 months
- •Uncontrolled arrhythmia (e.g., Afib with RVR, new onset Afib, ventricular tachycardia, escape rhythms)
- •Congestive heart failure (stage 3 or 4)
- •Exercise-induced asthma (not controlled on inhalers)
- •Chronic obstructive pulmonary disease (requiring home oxygen)
- •Renal failure
- •Pregnancy
- •Cognitive impairment
- •Severe retinopathy or neuropathy.
- •Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)
研究组 & 干预措施
Digital Exercise
干预措施: Digital Exercise (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 4 weeks
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Accuracy
时间窗: 4 weeks
Accuracy to predict lapses in exercise behavior ahead of time. 50% accuracy is the lowest possible value (ie, equivalent to random guessing), 80% accuracy is the goal of the study, and 100% accuracy would be the highest possible accuracy. This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.
Feasibility of Usage
时间窗: 4 weeks
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Acceptability
时间窗: 4 weeks
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Accuracy
时间窗: 4 weeks
Accuracy to predict lapses in exercise behavior ahead of time. 50% accuracy is the lowest possible value (ie, equivalent to random guessing), 80% accuracy is the goal of the study, and 100% accuracy would be the highest possible accuracy. This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.
次要结局
- Motivation States for Physical Activity(6 weeks)
- Moderate to Vigorous Physical Activity(6 weeks)
- Interview Themes(6 weeks)