A Reinforcement Approach to Improve Diabetes Management - Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- To determine if the reinforcement intervention increases SMBG testing.
研究概览
简要总结
The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 12-21 years old;
- •diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
- •receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines
- •SMBG user with clinical recommendations to test >4 times/day and using a device that allows for remote uploading (e.g., Aviva, Contour, Freestyle, Lifescan, etc.; equipment for uploading will be provided);
- •access to a computer with internet for uploading and sending SMBG data;
- •access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;
- •English speaking, able to read at >5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.
排除标准
- •have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
- •have a major visual impairment;
- •have a significant other medical condition that impacts diabetes management (e.g., asthma, rheumatoid arthritis, or other condition that requires steroid treatment);
- •plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched;
- •are participating in another clinical trial.
结局指标
主要结局
To determine if the reinforcement intervention increases SMBG testing.
时间窗: 6 Months
The number of SMBG tests will be assessed via glucometer uploads, and the proportion of days on which at least 4 tests occurred as well as the longest number of consecutive days on which SMBG tests occurred at frequencies of \>4 times/day will be calculated. The hypothesis is that patients assigned to the reinforcement intervention will conduct more SMBG tests, have greater proportions of days with \>4 tests, and have longer durations of appropriate testing frequencies than patients assigned to usual care.
To assess if the intervention reduces A1c
时间窗: 6 months
Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c over time than patients assigned to usual care.
次要结局
未报告次要终点