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Effectiveness of a Digital Therapeutic on Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369626
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
FareWell

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: FareWell Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: evaluation of pre/post measures of a single group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes
Actual Study Start Date : July 26, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369626


Locations
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United States, California
FareWell LLC
San Francisco, California, United States, 94108
Sponsors and Collaborators
FareWell
Investigators
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Principal Investigator: Mark Berman, MD FareWell
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Responsible Party: FareWell
ClinicalTrials.gov Identifier: NCT03369626    
Other Study ID Numbers: dmstudyv4
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases