A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

Study Overview
=================
Brief Summary
-----------------
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).

Detailed Description
-----------------
A prospective NOD Cohort of 10,000 eligible, enrolled subjects will be assembled over the next 3 years, with each patient participating for up to 3 years from the date they meet biochemical (glycemic) criteria for diabetes. Sites electronic medical record databases or other avenues for recruitment, such as physician and self referral, will be utilized to identify subjects meeting criteria for NOD.

Official Title
-----------------
A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort

Conditions
-----------------
Diabetes, Type2 Diabetes, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
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 information. Subject 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 A. (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR B. 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 C. Any (1) PDM present followed by an anti-diabetes medication Subject must have >1 glycemic parameter 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 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 on chronic or acute use of 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New-onset diabetes<br>Subjects with biochemically-defined new-onset diabetes | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes | Enrolled subjects will be followed for three years to determine the 1-year, 2-year, 3-year incidence rates of PDAC in new-onset hyperglycemia and diabetes. | 3 years | 
| Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and diabetes | We will retrospectively measure serum CA 19-9 in blood collected at baseline and at each subsequent blood draw to determine its ability to predict pancreatic cancer in presymptomatic subjects. We will also collect blood for future biomarker testing. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
New Onset Diabetes, Diabetes, Type 2 Diabetes