Inclusion Criteria:
≥ 50 years of age or older at the time of enrollment
Willing to sign the informed consent form
Must have 2 occurrences from among the below parameters of diabetes mellitus (PDMs) in past 90 days measured in outpatient setting (not in urgent care, emergency room or while inpatient):
FBG ≥126mg/dl HbA1c ≥6.5% RBG ≥ 200mg/dl 2-hour post-glucose ≥200mg/dl (OGTT)
Must have had glycemic parameter measured in 3-18 months prior to screening that did NOT meet DM criteria
Must be willing to provide several tubes of blood without endangering health
No history of pancreatic cancer or other known pancreatic neoplasia
No active cancers within the past 5 years (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment and in situ cancers)
Exclusion Criteria:
Prior DM diagnosis
Met criteria for DM ≥91 days prior to enrollment (patients with prior gestational diabetes that has resolved are NOT acceptable to enroll)
Carried a DM diagnosis or used anti-DM medications at a time greater than or equal to 91 days prior to enrollment
Any known pancreatic lesions (aside from diabetes)
Received cancer treatment within the past 5 years (with the exception of treatment of non-melanoma skin cancer), carrying a current cancer diagnosis, and/or being investigated for suspicion of past cancer recurrence.
Current chronic or acute oral steroid use
History of intra-articular steroid injections (<1 week) of the qualifying DM blood test (allowed exception: nasal, topical, oral budesonide)
Any surgery requiring general anesthesia within 2 months of collection
Local anesthetic (including dental novocaine) within 1 week of collection
History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD)
Blood transfusion within 1 month
Organ transplant recipient
Currently pregnant, or pregnancy within last 12 months
Receipt of systemic immunomodulation therapy within past 12 months
Significant medical condition that in the site investigator’s opinion would compromise the subject’s ability to tolerate study interventions
Source: View full study details on ClinicalTrials.gov
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