Early Detection Initiative for Pancreatic Cancer (EDI)

This is an interventional screening trial for Hyperglycemia focused on measuring New Onset Diabetes, Hyperglycemia, Diabetes Mellitus, Pancreatic Ductal Adenocarcinoma, ENDPAC score, Weight loss Read More

Inclusion Criteria:

• Patient must have given institutional consent for minimal risk studies.
• Patient must be ≥50 and ≤85 years of age at the time of diagnosis [index date Parameters of Diabetes Mellitus (PDM)].
• Patient must have index weight and left-window weight values available in electronic medical record (EMR).
• Patient must have hyperglycemia and/or diabetes as one of the following ≤90 days prior to randomization (all glycemic parameters, except for HbA1c, must be measured in an outpatient setting):

A. Glycated hemoglobin (HbA1c) ≥ 6.5%

OR

B. Any (2) PDMs on consecutive (≤90 days between PDMs) or simultaneous testing:

• Fasting Blood Glucose (FBG) ≥126 mg/dl
• Glycated hemoglobin (HbA1c) ≥ 6.5%
• Random Blood Glucose (RBG) ≥200 mg/dl
• 2 hour Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during oral glucose tolerance test (OGTT)

OR

C. Any one (1) PDM present followed by an anti- diabetes medication ≤90 days after the index PDM date

- Patient must have ≥1 glycemic parameter measured in the past 91-548 days prior to the index PDM date (Left Window) without meeting inclusion criteria A, B, or C.

Exclusion Criteria:

• Patient has declined institutional consent for minimal risk studies.

• Patient must not have any known past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

  *Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.

• Patient must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

  *Ongoing work up for suspicion of pancreatic cancer is not an exclusion.

• Patient must not have had a definitive diagnosis of pancreatic cancer prior to index PDM date.
• Patient must not be on any anti-diabetes medications prior to index PDM date.

• Patient must not be on chronic or acute use of steroid medications ≤90 days prior to the index PDM date.

  *Allowed: Nasal, topical steroids, oral budesonide, ophthalmic

• Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the index PDM date.