Type 2 DiabetesPRECISE DM DXNCT07111416
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
An observational study of Type 2 Diabetes, run by Brigham and Women's Hospital.
Trial summary
The goal of this observational study is to learn why some adults over the age of 65, have A1c tests that do not match up with their blood glucose levels, also known as 'A1c-glucose discordance'. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 May 2026
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Individuals 65 years of age and older, who have evidence of A1c-glucose discordance without either a diagnosis of type 2 diabetes or current/ prior treatment for type 2 diabetes
Who may be able to join
- Age 65 years of age or older
- A1c 5.3% - 7.4% without a diagnosis on the problem list and/or current or prior treatment for diabetes
- Evidence of A1c discordance by meeting one of two criteria developed by an EHR based algorithm
- At least five (5) HbA1c values and three (3) CBC values available in the EHR in the previous 10 years
- Willingness to wear an Abbott Freestyle Libre 3 System Sensor for up to 48 days
- Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities
Who cannot join
- Known or suspected diabetes of other causes (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
- Clinically significant anemia based on most recent hematocrit (M = <38%, F <33%) and/or hemoglobin (M = <12 g/dL, F = <10 g/dL) within the last 12 months
- Condition with short life expectancy
- Blood (hematologic) malignancy
- rtCGM-interference agents per manufacturer (e.g., high dose vitamin C)
- Unstable psychiatric or medical condition
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- Active treatment for cancer, planned treatment for cancer, or recent active cancer with a likelihood of recurrence or progression, that, in the opinion of the site investigator, would interfere with study therapy prior to 2029
- Allowed Exceptions: Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy. Examples of allowable cancers include:
- Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy
- Prostate cancer being observed
- Stage 0 or 1 tumors status post resection or other definitive treatment
- Other similarly stable cancer comorbidities
About this study
Official title: Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis (PRECISE DM Dx)
The goal of this observational study is to learn why some adults over the age of 65, have A1c tests that do not match up with their blood glucose levels, also known as 'A1c-glucose discordance'.
The main question it aims to answer is:
Could alternative tests like CGM or personalized A1c provide more accurate diabetes screening in this population?
Participants will be asked to perform blood tests every week to two weeks and wear a CGM for up to 8 weeks.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the Mean Absolute Difference Between A1c-Derived Estimated Average Glucose (eAG) and CGM-Derived eAG
Determine the mean absolute difference between estimated average glucose (eAG) calculated from hemoglobin A1c and eAG derived from Continuous Glucose Monitoring (CGM) data. This measure will be assessed among participants suspected of having discordance between A1c values and actual blood glucose levels.
Measured: From 1 week after enrollment to the end of their enrollment at either week 5 or week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Responsible party
- Principal investigator, Marie McDonnell, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111416
- Sponsor's protocol ID
- 2025P001596
- Acronym
- PRECISE DM DX
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis (PRECISE DM Dx)
- ClinicalTrials.gov ID
- NCT07111416
- Acronym / sponsor ID
- PRECISE DM DX / 2025P001596
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Aug 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.
The goal of this observational study is to learn why some adults over the age of 65, have A1c tests that do not match up with their blood glucose levels, also known as 'A1c-glucose discordance'.
The main question it aims to answer is:
Could alternative tests like CGM or personalized A1c provide more accurate diabetes screening in this population?
Participants will be asked to perform blood tests every week to two weeks and wear a CGM for up to 8 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Individuals 65 years of age and older, who have evidence of A1c-glucose discordance without either a diagnosis of type 2 diabetes or current/ prior treatment for type 2 diabetes
Key inclusion criteria (6 listed)
- Age 65 years of age or older
- A1c 5.3% - 7.4% without a diagnosis on the problem list and/or current or prior treatment for diabetes
- Evidence of A1c discordance by meeting one of two criteria developed by an EHR based algorithm
- At least five (5) HbA1c values and three (3) CBC values available in the EHR in the previous 10 years
- Willingness to wear an Abbott Freestyle Libre 3 System Sensor for up to 48 days
Key exclusion criteria (12 listed)
- Known or suspected diabetes of other causes (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
- Clinically significant anemia based on most recent hematocrit (M = <38%, F <33%) and/or hemoglobin (M = <12 g/dL, F = <10 g/dL) within the last 12 months
- Condition with short life expectancy
- Blood (hematologic) malignancy
- rtCGM-interference agents per manufacturer (e.g., high dose vitamin C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calculate the Mean Absolute Difference Between A1c-Derived Estimated Average Glucose (eAG) and CGM-Derived eAG
Time frame: From 1 week after enrollment to the end of their enrollment at either week 5 or week 10
Determine the mean absolute difference between estimated average glucose (eAG) calculated from hemoglobin A1c and eAG derived from Continuous Glucose Monitoring (CGM) data. This measure will be assessed among participants suspected of having discordance between A1c values and actual blood glucose levels.
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 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Brigham and Women's Hospital.
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 6 inclusion and 12 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Calculate the Mean Absolute Difference Between A1c-Derived Estimated Average Glucose (eAG) and CGM-Derived eAG (time frame: From 1 week after enrollment to the end of their enrollment at either week 5 or week 10). 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 Aug 2025.