Type 2 Diabetes Mellitus - Poor ControlCOMPASSNCT07054125
Continuous Glucose Monitoring, Diabetes Education, and Peer Support for Management of Uncontrolled Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus - Poor Control, run by Whole Endo at 1 site in United States.
Trial summary
This research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus - Poor Control
- What is being tested?
- Education, lifestyle counseling, and peer support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Aug 2028
- Phase
- Observational
- 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
Study population: North and South Carolina
Who may be able to join
- Adults aged 18 years and older
- Diagnosed with type 2 diabetes mellitus Hemoglobin A1c >8% Must have smartphone to connect with continuous glucose monitor
Who cannot join
- Pregnancy Use of steroids Active cancer treatment Terminal illness Dementia, mental impairment Type 1 diabetes End stage renal disease, on dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Javier Samayoa, EdD contact
United States1 site, 1 recruiting
- Recruiting
Whole Endo
Asheville, North Carolina, 28801
About this study
Official title: The COMPASS Program: Continuous Monitoring, Peer And Structured Support for Management of Uncontrolled Type 2 Diabetes - A Prospective Single-Arm Study
This research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes. People in the study will join group visits virtually to discuss using CGM, understanding CGM, and other information about ways to bring blood sugars to your goal (nutrition, movement, reducing stress, and techniques to start a new habit).
- Conditions
- Type 2 Diabetes Mellitus - Poor Control
- Being tested
- Education, lifestyle counseling, and peer support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, lifestyle counseling, and peer supportBehavioural
This research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes.
People in the study will join group visits virtually to discuss using CGM, understanding CGM, and other information about ways to bring blood sugars to your goal (nutrition, movement, reducing stress, and techniques to start a new habit).
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
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 posted8 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus - Poor ControlStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whole Endo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054125
- Sponsor's protocol ID
- 43318527
- Acronym
- COMPASS
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMPASS Program: Continuous Monitoring, Peer And Structured Support for Management of Uncontrolled Type 2 Diabetes - A Prospective Single-Arm Study
- ClinicalTrials.gov ID
- NCT07054125
- Acronym / sponsor ID
- COMPASS / 43318527
- Conditions
- Type 2 Diabetes Mellitus - Poor Control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Whole EndoIndustry (pharma, biotech, devices)
- Collaborators
- DexCom, Inc.
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 8 Jul 2025 (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 research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes. People in the study will join group visits virtually to discuss using CGM, understanding CGM, and other information about ways to bring blood sugars to your goal (nutrition, movement, reducing stress, and techniques to start a new habit).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- North and South Carolina
Key inclusion criteria (2 listed)
- Adults aged 18 years and older
- Diagnosed with type 2 diabetes mellitus Hemoglobin A1c >8% Must have smartphone to connect with continuous glucose monitor
Key exclusion criteria (1 listed)
- Pregnancy Use of steroids Active cancer treatment Terminal illness Dementia, mental impairment Type 1 diabetes End stage renal disease, on dialysis
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 |
|---|---|---|
| Education, lifestyle counseling, and peer supportThis research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes. People in the study will join group visits virtually to discuss using CGM, understanding CGM, and other information about ways to bring blood sugars to your goal (nutrition, movement, reducing stress, and techniques to start a new habit). | Behavioural | – |
Primary outcome
Hemoglobin A1c
Time frame: 12 weeks
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 8 Jul 2025.
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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.
Javier Samayoa, EdD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus - Poor Control, run by Whole Endo 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. 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 Rashim Gupta, MD (980-349-6036, rashim.gupta@wholeendo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (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 8 Jul 2025.