A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals

The primary object of this study is to obtain a series of blood and urine specimens from women and men who are healthy with no history of abnormal blood sugar levels. The specimens will be used to evaluate new C-peptide and insulin assays (tests). Participants are being asked to voluntarily take part in this study because they are a healthy individual without a history of abnormal blood sugar levels.

Inclusion criteria

• Males and females, age ≥ 18 years
• Fasting for 12 hours prior to blood draw and random urine collection
• Able to understand and willing to provide informed consent
• Normal HbA1c (e.g. less than 5.7%) and glucose (e.g. less than 100 mg/dL) levels

Exclusion criteria

• Males and females, age <18 years
• Has a current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, would deem the subject unhealthy and therefore, ineligible.
• Has a history of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, is unstable at the time of enrollment.
• Current diagnosis or prior history of any type of diabetes including gestational diabetes.
• Currently taking or history of insulin therapy for any disease.
• Elevated HbA1c level (e.g. greater than 5.7%)
• Elevated glucose level (e.g. greater than or equal to 100 mg/dL)
• Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.
• History of seizures
• Diagnosed with an infectious disease including any sexually transmitted diseases.
• Diagnosed with HIV/AIDS or ever tested positive for HIV.
• History of hepatitis
• Subject that has had sexual contact with a person who has hepatitis within the last 12 months.
• Pregnancy or lactation
• Non-fasting for 12 hours prior to blood and random urine collection.
• Hemolytic blood specimen
• Unable to provide informed consent