NCT03369626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

December 6, 2017

Last Update Submit

August 19, 2019

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in self-reported Hemoglobin A1c

    12 weeks

  • Change in self-reported diabetes medication type or dose

    12 weeks

Study Arms (1)

FareWell Program

OTHER

All participants receive the FareWell Program intervention in this evaluation study

Behavioral: FareWell Program

Interventions

FareWell ProgramBEHAVIORAL

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.

FareWell Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of type 2 diabetes

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FareWell LLC

San Francisco, California, 94108, United States

Location

Study Officials

  • Mark Berman, MD

    FareWell

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: evaluation of pre/post measures of a single group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 12, 2017

Study Start

July 26, 2017

Primary Completion

January 31, 2018

Study Completion

February 28, 2018

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

US(1)