Type2 DiabetesNCT03369626
Effectiveness of a Digital Therapeutic on Type 2 Diabetes
A study testing FareWell Program in people with Type2 Diabetes, run by FareWell at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- FareWell Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 diabetes
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With 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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- FareWell Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FareWell ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| FareWell Program | Other | All participants receive the FareWell Program intervention in this evaluation study Receives: Behavioral: FareWell Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (2)
Change in self-reported Hemoglobin A1c
Comparison of baseline and end program self reported Hemoglobin A1c
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start26 Jul 2017
- Primary completion31 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- evaluation of pre/post measures of a single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- FareWell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Berman, MD, Principal investigator, FareWell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369626
- Sponsor's protocol ID
- dmstudyv4
- Status last verified
- Aug 2019
- First submitted
- 6 Dec 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03369626
- Acronym / sponsor ID
- dmstudyv4
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- FareWellIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- evaluation of pre/post measures of a single group
| Arm | Type | Receives |
|---|---|---|
| FareWell Program | Other | Behavioral: FareWell ProgramAll participants receive the FareWell Program intervention in this evaluation study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of type 2 diabetes
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FareWell ProgramThe 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. | Behavioural | FareWell Program |
Primary outcome
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)
2 secondary outcomes
Change in self-reported Hemoglobin A1c
Time frame: 12 weeks
Change in self-reported diabetes medication type or dose
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Berman, MD principal investigator
FareWell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FareWell Program in people with Type2 Diabetes, run by FareWell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of engagement with the assigned mobile app (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.