Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis

Prior treatment

• 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

Other illness

• Known or suspected diabetes of other causes (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
• Condition with short life expectancy
• Blood (hematologic) malignancy
• Unstable psychiatric or medical condition

Lab values

• 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

Other

• rtCGM-interference agents per manufacturer (e.g., high dose vitamin C)

• 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