Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Pilot Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Weekly exercise duration
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 remote participation-based 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. You do not need to live in Connecticut to participate, as there will be no required in-person visits during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •30-65 years old inclusive
- •Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
- •Less than 1.0 exercise sessions per week
- •Smartphone ownership
- •English literacy
- •Under regular care by a healthcare provider (1+ appointments per year)
- •Home Broadband wireless Internet or cell phone network
- •Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks
- •Using insulin pump or pen and sharing data with medical record for at least 6 weeks
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., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, 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
Self-Monitoring
Wear a fitness watch and keep daily health diary
干预措施: Self-monitoring (Behavioral)
Exercise program
Participants will receive a free Garmin smartwatch and a free program membership providing exercise coaching + personalized feedback about the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar.
干预措施: Exercise program (Behavioral)
结局指标
主要结局
Weekly exercise duration
时间窗: 20 weeks
Minutes/week. Measured by blinded hip watch and periodic interviews. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
次要结局
- Waist circumference(20 weeks)
- Blood pressure(20 weeks)
- Exercise self-efficacy(20 weeks)
- Weekly exercise volume(20 weeks)
- Weekly exercise days(20 weeks)
- Glucose(20 weeks)
- Body mass index(20 weeks)
- Exercise self-regulation(20 weeks)
- Sleep disturbance(20 weeks)
- Sleep-related impairment(20 weeks)
- Affective motivation states(20 weeks)
- Fear of hypoglycemia(20 weeks)
- Fear of hyperglycemia(20 weeks)
研究者
Garrett I Ash, PhD
Assistant Professor of Medicine, Biomedical Informatics, and Data Science
Yale University