TABLE 1.
Study Definitions and Criteria Used in the NOD Study
| Terms | Study Definitions |
|---|---|
| Glycemic Parameters | Only the following glycemic parameters measured in outpatient setting are to be assessed: • Fasting blood glucose (FBG) • Random (non-fasting) glucose • Glycosylated hemoglobin (HbA1c) • 2h blood glucose following 75 gm glucose load (oral glucose tolerance test [OGTT]) The following glucose measurements are not included: urine glucose, other body fluid glucose, blood glucose measured in emergency department, urgent care, or inpatient setting |
| Parameters of Diabetes Mellitus (PDM) | • Fasting blood glucose (≥126 mg/dl) • Random blood glucose (≥200 mg/dl) • Glycosylated hemoglobin (HbA1c) (≥6.5%) • 2h post oral glucose load (PG) ≥200 mg/dl during OGTT |
| Diagnosis of Diabetes (DxDM) | Any (1) of the following: • Any (2) PDMs present on consecutive or simultaneous testing • On anti-diabetic medications preceded by at least (1) PDM* |
| Date of meeting criteria for DM (DtDM) | Whichever of the following is earliest: • Date of first of (2) consecutive or simultaneous measured PDMs • Date of first PDM if patient is started on anti-DM medications following this measurement |
| New-onset DM | Meets all the following criteria: • Age ≥50 and ≤85 years • Date of meeting criteria for DM ≤90 days prior to enrollment • Have had glycemic parameter(s) measured in the 3-18 months prior to screening (demonstrating absence of PDM) |
| PDAC Definition |
• Definite: Requires biopsy proof of pancreatic adenocarcinoma on autopsy, biopsy, or surgical resection of pancreatic lesion or adenocarcinoma on biopsy of a metastatic lesion with imaging evidence of pancreatic mass • Probable: presence of one of the following: 1. Obstructive jaundice and low-density pancreatic head mass, OR 2. Low density pancreatic mass and elevated serum CA 19-9 level • Possible: Jaundice, anorexia, and/or weight loss associated with an indeterminate pancreatic lesion or normal pancreatic imaging |
*
If patient has (1) PDM and has started anti-diabetic medication within 3 months; repeat value may or may not meet PDM, patient is still eligible.