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| Name | Class |
|---|---|
| Abbott Diabetes Care | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 1 week after enrollment to the end of their enrollment at either week 5 or week 10 |
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Inclusion Criteria:
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:
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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
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |