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OpenTrials
Completed

NCT Number: NCT03369626

Effectiveness of a Digital Therapeutic on 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.

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Key information

Conditions

Type2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FareWell LLC

San Francisco, California, 94108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FareWell Program

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in self-reported Hemoglobin A1c

    Time frame: 12 weeks

    Comparison of baseline and end program self reported Hemoglobin A1c

  2. 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

Sponsors and collaborators

Lead sponsor

FareWell

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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