Diabetes Mellitus ( Type 1 and Type 2)NCT07904793
Care COMPASS Study
A study testing Guide My Care Tool in people with Diabetes Mellitus ( Type 1 and Type 2) and Hypertension, run by Fitbit LLC at 1 site in United States.
Trial summary
This is a prospective, single-arm, mixed-methods pilot study at a single academic medical center to observe the impact, feasibility and acceptability of an AI Care Companion tool on activation and confidence among patients with chronic disease attending outpatient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus ( Type 1 and Type 2), Hypertension
- What is being tested?
- Guide My Care Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age: Legal adult (18+)
- Existing diagnosis of Diabetes Mellitus Type 1 / 2 and/or hypertension who have had at least two outpatient visits in the prior 12 months.
- Scheduled in-person clinician appointment for follow up of Diabetes Mellitus -----Type 1 / 2 and/or hypertension within the next 4 months
- Anticipate ongoing care with their current clinic for at least one month following their clinic visit for this research study.
- Able to contact their health care team as needed (by telephone, messaging or other) in the 2 weeks following their clinic visit.
- Able to read and write in English
Show all 9Show fewer
- Has an active patient portal account
- Current user of smart phones.
- Access to wifi or internet
Who cannot join
- Patients with emergency or acute medical issues arising at their scheduled appointment
- Pregnancy (based on self-report or medical records),
- Any other medical condition or other reason- as determined by the principal investigator or designee - that may affect participant involvement, study procedures or data collection
- Participants who have already participated in this study.
- Participating currently (or in the last 6 months) with a clinical trial of a health coaching intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health & Sciences University
Portland, Oregon, 97239
Jeffrey Gold, MD, 503-494-4806, goldje@ohsu.edu
Jeffrey Gold, MD
About this study
Official title: Care COMPASS Study: (Care Companion for Patient Activation and Self-Support)
This is a prospective, single-arm, mixed-methods pilot study at a single academic medical center to observe the impact, feasibility and acceptability of an AI Care Companion tool on activation and confidence among patients with chronic disease attending outpatient care.
- Being tested
- Guide My Care Tool
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guide My Care ToolOther
Participants are equipped with the Guide My Care tool across three study touchpoints.
| Study group | Role | What they receive |
|---|---|---|
| Guide My Care Tool | Experimental | Not described Receives: Other: Guide My Care Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a Care Companion tool
To explore the effectiveness of a Care Companion tool on self-efficacy to manage their health related to their clinical encounter, among patients presenting to outpatient care for chronic disease management
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start22 Oct 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus ( Type 1 and Type 2)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fitbit LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Matthew Thompson, MD, Principal investigator, Google LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904793
- Sponsor's protocol ID
- GH-BMX-02
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care COMPASS Study: (Care Companion for Patient Activation and Self-Support)
- ClinicalTrials.gov ID
- NCT07904793
- Acronym / sponsor ID
- GH-BMX-02
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fitbit LLCIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 29 Oct 2026 (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.
This is a prospective, single-arm, mixed-methods pilot study at a single academic medical center to observe the impact, feasibility and acceptability of an AI Care Companion tool on activation and confidence among patients with chronic disease attending outpatient care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guide My Care Tool | Experimental | Other: Guide My Care Tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: Legal adult (18+)
- Existing diagnosis of Diabetes Mellitus Type 1 / 2 and/or hypertension who have had at least two outpatient visits in the prior 12 months.
- Scheduled in-person clinician appointment for follow up of Diabetes Mellitus -----Type 1 / 2 and/or hypertension within the next 4 months
- Anticipate ongoing care with their current clinic for at least one month following their clinic visit for this research study.
- Able to contact their health care team as needed (by telephone, messaging or other) in the 2 weeks following their clinic visit.
Key exclusion criteria (5 listed)
- Patients with emergency or acute medical issues arising at their scheduled appointment
- Pregnancy (based on self-report or medical records),
- Any other medical condition or other reason- as determined by the principal investigator or designee - that may affect participant involvement, study procedures or data collection
- Participants who have already participated in this study.
- Participating currently (or in the last 6 months) with a clinical trial of a health coaching intervention.
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 |
|---|---|---|
| Guide My Care ToolParticipants are equipped with the Guide My Care tool across three study touchpoints. | Other | Guide My Care Tool |
Primary outcome
Effectiveness of a Care Companion tool
Time frame: 6 months
To explore the effectiveness of a Care Companion tool on self-efficacy to manage their health related to their clinical encounter, among patients presenting to outpatient care for chronic disease management
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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.
Matthew Thompson, MD principal investigator
Google LLC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guide My Care Tool in people with Diabetes Mellitus ( Type 1 and Type 2) and Hypertension, run by Fitbit LLC 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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bhavna Daryani ((201) 885-9852, bhavnad@google.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a Care Companion tool (time frame: 6 months). 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 29 Oct 2026.