Using an AI-based Voice Assistant to Manage Insulin in Diabetes: a Randomized-Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Time to Optimal Insulin Dose
研究概览
简要总结
This study randomizes participants to have their basal insulin titrated either through standard of care or by receiving prompts through interactions with an AI-enabled smart speaker device. The primary objective of this study is to investigate the feasibility of an AI-enabled smart speaker device and whether such a device facilitates insulin titration management, increases insulin adherence and decreases time to optimal insulin dose. The secondary objective of the study is to explore whether the device improves glycemic control as defined by improvements in fasting blood sugar.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Type 2 Diabetes
- •Patients clinically indicated to be taking daily long-acting insulin
- •Patients currently taking long-acting insulin but necessitating active dose adjustments
排除标准
- •Patients who do not speak English
- •Patients who do not own a smart phone
- •Patients who do not have stable wireless internet connection at home
结局指标
主要结局
Time to Optimal Insulin Dose
时间窗: 8 weeks
Number of days between study start date and goal fasting sugar
Insulin Medication Adherence
时间窗: 8 weeks
Percentage of adherence to taking insulin based on logs over 8 weeks
Attitudes Toward Health Technology
时间窗: Baseline and 8 weeks
Change in Composite Score of Attitudes Toward Health Technology. A 2-item self-report questionnaire on a 5 point Likert scale, scored 0 to 4. The scores are summed to create an overall score (Minimum value = 0, Maximum value = 8). Higher scores indicated more favorable attitudes toward health technology.
Attitudes Toward Medication Adherence
时间窗: Baseline and 8 weeks
Change in Composite Score of Attitudes Toward Medication Adherence. A 5-item self-report questionnaire on a 5-point Likert scale (0 to 4). The scores are summed to create an overall score (Minimum value = 0, Maximum value = 20). Higher scores indicate more favorable attitudes toward medication adherence.
Attitudes Toward Diabetes
时间窗: Baseline and 8 weeks
Change in Composite Score of Attitudes Toward Diabetes (PAID-5). A 5-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores of each item are summed to create an overall score (Minimum value = 0; Maximum value = 20). Higher scores denote higher levels of diabetes related distress.
次要结局
- Percentage of Participants Who Achieved Glycemic Control(8 weeks)
- Glycemic Improvement(Day 3 and 8 weeks (assessed at the end of each 3 day period))
研究者
Kevin Schulman
Professor of Medicine
Stanford University