Effectiveness of a Digital Therapeutic on Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03369626|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes||Behavioral: FareWell Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||evaluation of pre/post measures of a single group|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes|
|Actual Study Start Date :||July 26, 2017|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||February 28, 2018|
All participants receive the FareWell Program intervention in this evaluation study
Behavioral: FareWell Program
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.
- Level of engagement with the assigned mobile app [ Time Frame: 12 weeks ]How do participants interact with the digital program (e.g. feature use, coaching calls completed, targets tracked, targets met)
- Change in self-reported Hemoglobin A1c [ Time Frame: 12 weeks ]Comparison of baseline and end program self reported Hemoglobin A1c
- Change in self-reported diabetes medication type or dose [ Time Frame: 12 weeks ]Comparison of diabetes medications reported at baseline to any changes reported at the end of the study or mid-study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369626
|United States, California|
|San Francisco, California, United States, 94108|
|Principal Investigator:||Mark Berman, MD||FareWell|