Effectiveness of a Digital Therapeutic on Type 2 Diabetes
Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes
研究概览
详细说明
The Program aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. It includes meal planning tools, smart shopping lists, recipes curated by a physician, dietitian and chef educator, daily self-monitoring features with personalized weekly goals, bi-weekly live one-on-one health coaching and support from an online member community, and an educational curriculum. Subjects in the Program may receive support from other members of a Care Team (lifestyle medicine physician, chef educator, registered dietitian and/or psychologist/psychiatrist) as needed. The Care Team does not provide medical advice, nor replace traditional medical care. Instead, the Care Team encourages behavior change by providing support and sharing its expertise.
Study participants will have access to the Program for a twelve week period and will be asked to complete short health surveys at baseline and at the end of the study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94108
- FareWell LLC
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- diagnosis of type 2 diabetes
Exclusion Criteria:
- Inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend English.
- Does not have a smartphone (either an iPhone or Android phone)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：FareWell Program
All participants receive the FareWell Program intervention in this evaluation study
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The FareWell Program is a digitally delivered lifestyle management curriculum, which includes meal planning tools, daily self monitoring, personalized goal setting and bi-weekly live one-on-one health coaching.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Level of engagement with the assigned mobile app
大体时间：12 weeks
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How do participants interact with the digital program (e.g.
feature use, coaching calls completed, targets tracked, targets met)
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in self-reported Hemoglobin A1c
大体时间：12 weeks
|
Comparison of baseline and end program self reported Hemoglobin A1c
|
12 weeks
|
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Change in self-reported diabetes medication type or dose
大体时间：12 weeks
|
Comparison of diabetes medications reported at baseline to any changes reported at the end of the study or mid-study
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12 weeks
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合作者和调查者
赞助
调查人员
- 首席研究员：Mark Berman, MD、FareWell
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.