Effectiveness of a Digital Therapeutic on Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Behavioral: FareWell Program

• Registration Number: NCT03369626
• Lead Sponsor: FareWell

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-07-26
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-12
• Primary Completion: 2018-01-31
• Study Completion: 2018-02-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FareWell Program	FareWell Program	All participants receive the FareWell Program intervention in this evaluation study

Primary Outcome Measures

Name	Time	Method
Level of engagement with the assigned mobile app	12 weeks	How do participants interact with the digital program (e.g. feature use, coaching calls completed, targets tracked, targets met)

Secondary Outcome Measures

Name	Time	Method
Change in self-reported Hemoglobin A1c	12 weeks	Comparison of baseline and end program self reported Hemoglobin A1c
Change in self-reported diabetes medication type or dose	12 weeks	Comparison of diabetes medications reported at baseline to any changes reported at the end of the study or mid-study

Trial Locations

Locations (1)

FareWell LLC; 🇺🇸 San Francisco, California, United States