Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention
研究概览
简要总结
A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods).
All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to.
The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form
- •Self-reported diagnosis of type 1 diabetes for at least 5 years
- •Previous attendance of structured diabetes education program
- •Using CGM greater or equal to (≥1) year
- •Ongoing Dexcom CGM use time ≥70% based on CGM report at screening
- •Have had experienced ≥1 episode of severe hypoglycemia in the past year while using CGMs or spending ≥1% of time in level 2 hypoglycemia at the time of pre-screening
- •Using cellphone with functionality for sharing real-time data to Dexcom Clarity and receiving text messages
- •Be able to communicate in English (spoken and written)
- •Willing to comply with all study procedures including sharing CGM glucose information, receiving and reading intervention text messages, and completing study questionnaires
排除标准
- •Active participation in clinical trials on diabetes/hypoglycemia interventions
- •Pregnancy or planning for pregnancy within a year
- •Untreated adrenal insufficiency or hypothyroidism
- •Uncontrolled mental disorder or chronic cognitive dysfunctions (include but not limited to uncontrolled schizophrenia, depression and bipolar disorders; learning disability; active alcohol and substance dependence; dementia or cognitive impairment independent of hypoglycemia)
结局指标
主要结局
The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention
时间窗: Approximately 4.5 months
This number will include participants that were enrolled and received part or all of the intervention.
次要结局
- Number of Potential Candidates Contacted During the Entire Recruitment Period(Approximately 1 year (recruitment period))
- Percentage of Contacted Potential Candidates Being Eligible(Approximately 1 year (recruitment period))
- Rate of Participant Retention at 12 Weeks(12 weeks)
- Rate of Participant Retention at 26 Weeks(6 months)
- Rate of Participant Retention at 52 Weeks(1 year)
- Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks(12 weeks)
- Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks(6 months)
- Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks(1 year)
- Participants Reporting Reading Message Content at the End of the Intervention(12 weeks)
- Participants Finding Message Content Helpful (Positive) at the End of the Intervention(12 weeks)
研究者
Yu Kuei Alex Lin
Associate Professor of Internal Medicine
University of Michigan