Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Level of engagement with the assigned mobile app
研究概览
简要总结
A clinical study evaluating a three month digitally delivered lifestyle change program in adults with Type 2 Diabetes. The FareWell Program (the "Program") aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. The current study is designed to evaluate to what degree adults with Type 2 Diabetes engaged with the Program can improve glycemic control and/or decrease medication needs.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •diagnosis of type 2 diabetes
排除标准
- •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)
研究组 & 干预措施
FareWell Program
All participants receive the FareWell Program intervention in this evaluation study
干预措施: FareWell Program (Behavioral)
结局指标
主要结局
Level of engagement with the assigned mobile app
时间窗: 12 weeks
How do participants interact with the digital program (e.g. feature use, coaching calls completed, targets tracked, targets met)
次要结局
- Change in self-reported Hemoglobin A1c(12 weeks)
- Change in self-reported diabetes medication type or dose(12 weeks)
