Effectiveness of a Digital Therapeutic on Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369626
• Other study ID #: dmstudyv4
• Status: Completed
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2019
• Source: FareWell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 28, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	FareWell LLC	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
FareWell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in self-reported Hemoglobin A1c	Comparison of baseline and end program self reported Hemoglobin A1c	12 weeks
Secondary	Change in self-reported diabetes medication type or dose	Comparison of diabetes medications reported at baseline to any changes reported at the end of the study or mid-study	12 weeks