Effectiveness of a Digital Therapeutic on Type 2 Diabetes

August 19, 2019 updated by: FareWell

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94108
        • FareWell LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FareWell Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported Hemoglobin A1c
Time Frame: 12 weeks
Comparison of baseline and end program self reported Hemoglobin A1c
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FareWell

Investigators

  • Principal Investigator: Mark Berman, MD, FareWell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2017

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dmstudyv4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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