Clinical Trials

Inclusion Criteria:

1. Willing to provide informed consent and sign an informed consent form.
2. Must sign an authorization for the release of their protected health information.

Candidates must be ≥50 and ≤85 years of age

1. Must have at least (1) Parameter of Diabetes Mellitus in the past (3) months:

• 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)

*Only the aforementioned glycemic parameters measured in outpatient setting are to be included.*

1. Must have had glycemic parameters measured in the 3-18 months prior to screening without meeting criteria for DM or be on anti-DM medications

1. Patient must be willing to provide blood samples (fasted) at baseline. 
2. For subsequent serial bio-sampling, patient must meet criteria for NOD (New onset diabetes) (see Table 1 in Section 3.0) and be willing to provide blood samples (fasted) at 6, 12, and 24 months post-enrollment

Subjects or authorized representative must be willing to complete a  detailed questionnaire

In physician’s judgement, patient’s co-morbidities do not limit patient’s participation in study interventions (blood draw and questionnaire)

Exclusion Criteria:

1. Patient met criteria for DM >90 days prior to enrollment, carried a physician diagnosis of DM or used anti-DM medications in the 3-18 months prior to enrollment
2. Has had no glycemic parameter measured within 3-18 months prior to enrollment

1. Patients 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)
2. Any past history of pancreatic cancer

1. Current chronic or acute oral steroids
2. Recent (within 1 week) intra-articular steroid injection

Allowed: Nasal, topical steroids, oral budesonide, ophthalmic

Blood sugar measured in stressful situations such as urgent care, emergency room, or as inpatient

Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate study interventions.