Clinical Trials

Inclusion Criteria:

• Patient must be ≥ 50 and ≤ 85 years of age at the time of diagnosis (index PDM date).
• Patient is able and willing to provide informed consent and sign an informed consent form ≤ 90 days after the index PDM date.
• Patient must sign an authorization for the release of their protected health information ≤ 90 days after the index PDM date.

New Onset Hyperglycemia and Diabetes (NOD) related:

• Patient must have hyperglycemia and/or diabetes defined as one of the following in ≤ 90 days prior to the date of study consent.
• *All glycemic parameters, except for HbA1c, must be measured in an outpatient setting:
  • (1) Glycated hemoglobin (HbA1c) ≥ 6.5% present
    • HbA1c measured in urgent care, emergency department, or inpatient is acceptable; 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.*
    • *Patient is still eligible if there are non-elevated glycemic parameters following anti-diabetes medication.
• Patient must have > 1 glycemic parameter measured in the past 548 days (approximately 18 months) prior to the index PDM date without meeting inclusion criteria A, B, or C.

Biospecimen and Questionnaire:

• Patient must be willing to provide blood samples (fasting) at baseline, and at 6, 12, and 24 months after baseline.
• Patient or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

Personal history of Hyperglycemia, Diabetes, and Cancer:

• Patient must not have any known past history of hyperglycemia and/or diabetes.
  • *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 any past history of pancreatic cancer.

Diabetes and Steroid Medications:

• Patient must not be on any diabetes medications prior to the 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.

Chronic Severe Illness:

• In the physician’s and/or investigator’s judgement, patient does not have any co-morbidities that limit the patient’s participation in the study.