Effectiveness of a Digital Therapeutic on Type 2 Diabetes

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: FareWell Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: evaluation of pre/post measures of a single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FareWell Program<br>All participants receive the FareWell Program intervention in this evaluation study | Behavioral: FareWell Program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of engagement with the assigned mobile app | How do participants interact with the digital program (e.g. feature use, coaching calls completed, targets tracked, targets met) | 12 weeks | 

Secondary Outcome Measures

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