Effectiveness of a Digital Therapeutic on Type 2 Diabetes

NCT ID: NCT03369626

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-26

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

evaluation of pre/post measures of a single group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FareWell Program

All participants receive the FareWell Program intervention in this evaluation study

Group Type OTHER

FareWell Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FareWell

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Berman, MD

Role: PRINCIPAL_INVESTIGATOR

FareWell

Locations

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FareWell LLC

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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dmstudyv4

Identifier Type: -

Identifier Source: org_study_id

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