Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 12, 2017
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE July 26, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Change in self-reported Hemoglobin A1c [ Time Frame: 12 weeks ]
    Comparison of baseline and end program self reported Hemoglobin A1c
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Digital Therapeutic on Type 2 Diabetes
Official Title  ICMJE Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE FareWell Program
All participants receive the FareWell Program intervention in this evaluation study
Intervention: Behavioral: FareWell Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
118
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
250
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03369626
Other Study ID Numbers  ICMJE dmstudyv4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party FareWell
Original Responsible Party Same as current
Current Study Sponsor  ICMJE FareWell
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Berman, MD FareWell
PRS Account FareWell
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP