Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis (PRECISE DM Dx)
Overview
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.
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07111416 · 2025P001596