Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Brief Summary: The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.


Options:
A: Inclusion Criteria:

* Adults (age ≥ 18 years)
* Hispanics/Latinos
* ESRD patients who are scheduled to attend each participating transplant center's education sessions. Sessions mark the first phase of evaluation in order for patients to get wait listed for a transplant or for others to become a living kidney donor.
* Family and friends who accompany patients to the transplant center.
* Identification as Hispanic/Latino.
* Ability to come to Northwestern 3 hours prior to the scheduled education session.
* Ability to read. Reading ability will be assessed using the 5-point Likert scale question validated in English and Spanish:13 "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" People will be included if they reply 1-Never or 2-Rarely.

Exclusion Criteria:

* Non-identification as Hispanic/Latino.
* Inability to come to Northwestern 3 hours prior to the scheduled education session.
* Individuals who are not able to read Spanish or English. People will be excluded if they reply 3-Sometimes, 4-Often, and 5-Always to the question, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" .
B: Inclusion Criteria:

* receipt of primary care at a VISN 10 Northeast Ohio CBOC
* GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and
* at least one primary care visit in the year prior to study initiation.

Exclusion Criteria:

* ESRD as defined by chronic renal replacement therapy,
* receipt of a renal transplant,
* hospice care, and
* age greater than 85 years or less than 18 years at the time of study initiation.
C: Inclusion Criteria:

* Men and women (non-pregnant and non-childbearing potential)
* Diagnosis of type 1 diabetes mellitus for at least 3 years
* Stable diabetic treatment
* Willingness to use a continuous glucose meter
* Acceptable candidate for implantation

Exclusion Criteria:

* Advanced complications associated with diabetes
* Immunosuppressive therapy
D: Inclusion Criteria:

* ages 18-70 years and known to have diabetes and/or hypertension.
* eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.

Exclusion Criteria:

* unstable/advanced cardiovascular disease
* active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells \>3 cells/high power field or urine white blood cells \>10 cells/high power field).

Answer: C