Clinical Trials

Inclusion Criteria:

• Subject is able and willing to provide informed consent and sign an informed consent form.
• Subject must sign an authorization for the release of their protected health.
• Candidates must be ≥ 50 and ≤ 85 years of age at the time of enrollment.
• Subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment:
  • *All glycemic parameters must be measured in an outpatient setting.
  • Hemoglobin A1c (HbA1c) ≥ 6.5% present; or
  • Any (2) PDMs present on consecutive or simultaneous testing:
    • Fasting Blood Glucose (FBG) ≥ 126 mg/dl;
    • Hemoglobin A1c (HbA1c) ≥ 6.5%;
    • Random Blood Glucose (RBG) ≥ 200 mg/dl;
    • 2h Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test); or
  • Any (1) PDM present followed by an anti-diabetes medication.
• Subject must have > 1 had glycemic parameters measured in the 18 months prior to the elevated index lab without meeting inclusion criteria A, B, or C.
• Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment.
• Subject or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

• Subject must not have any 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.
• Subject must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or or be 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.
• Subject must not have any past history of pancreatic cancer.
• Subject must not be on anti-diabetes medications prior to the elevated index lab.
• Subject must not be onCurrent chronic or acute use oforal steroid medications within 90 days of the elevated index lab.
  • *Allowed: Nasal, topical steroids, oral budesonide, ophthalmic.
• Subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection.
• In the physician’s and/or investigator’s judgement, subject does not have any co-morbidities that limit the subject’s participation in the study.
• This study was designed to include women and minorities, but was not designed to measure differences among them.
• Males and females will be recruited with no preference to gender.
• No exclusion to this study will be based on race.
• Minorities will actively be recruited to participate.