Evaluating Game-based Pediatric Diabetes Education
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in glucose average and variability
研究概览
简要总结
The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).
The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.
详细描述
Youth with T1D who comply with inclusion criteria and provide consent will be randomized to either the treatment arm (will be given a tablet with the game) or the control arm (no tablet will be given, no exposure to the game). Participants in both arms will continue receiving standard of care treatment. Participants will be asked to maintain food and activity logs and answer questionnaires about lifestyle.
Participants will be evaluated at baseline and at 3 months with interim contact in between. Devices will be downloaded to collect app usage data (game telemetry). Exposure time will be tracked by the application. Survey to elicit barriers and challenges encountered during the study will also be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the age of 6 to 12 years.
- •Have been diagnosed with type 1 diabetes for at least 1 year.
- •Be currently taking insulin through multiple daily injections or an insulin pump.
- •Check blood sugar with a meter at least 4 times per day or use a continuous glucose monitor.
- •Be willing to comply with all study visits and procedures.
- •For Parent:
- •Biological or adopted parent with custody and medical decision making of the patients
- •Living with identified patients
- •Over 18 years old
- •Resident of Allegheny County
排除标准
- •Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.
研究组 & 干预措施
DVx-T1D+Standard Care
Participants will continue receiving the clinic's standard of care. Anthropometrics, clinical and laboratory data will be collected at three time points, baseline, 6 weeks and 3 months. Participants will be asked to maintain food, glucose, and activity logs. In addition, participants in this arm will be provided a tablet that has the gaming applications already loaded and receive training on the application. Exposure time will be tracked by the application.
干预措施: DVx-T1D™ app (Behavioral)
Standard Care
Participants will receive the clinic's standard of care. Anthropometrics, clinical and laboratory data will be collected at three time points, baseline, 6 weeks and 3 months. Participants will be asked to maintain food, glucose, and activity logs.
结局指标
主要结局
Change in glucose average and variability
时间窗: Three months
Change in glucose average and variability as assessed by mean glucose and standard deviation (SD) as well as other continuous glucose monitor (CGM) parameters for those using this device.
Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention
时间窗: Three months
Change in HbA1C level and insulin dose adjusted HbA1c from baseline to 3 months.
次要结局
- Changes in the quality of food consumption(Three months)
- Change in game play patterns over time(Three months)
研究者
Rema Padman
Trustees Professor of Management Science & Healthcare Informatics
Carnegie Mellon University