Please select the eligibility criteria that correspond to the clinical trial below.
Title: Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
Brief Summary: Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally and Asian Indians will account for between 40-60% of the global CVD burden within the next 10-15 years. Risk factor control and preventive care are effective in reducing CVD events and mortality. The greatest gains in CVD prevention have been seen when early and target-driven interventions address multiple risk factors together. However, achieving control of even individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor, globally. Quality improvement schemes, like the proposed intervention, have shown promise in high-income countries, but are untested in South Asia; a region with a population at extraordinarily high CVD risk.

Objective: To test whether a clinic-based case management intervention (consisting of guidelines based treatment, care coordinator assistance and decision support software) to reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is more effective and sustainable compared to existing care.

Trial subjects and methods: The study will involve a total of 1120 patients attending 8 established out-patient clinics in South Asia (140 patients at each clinic). Patients enrolled in the trial will be randomly assigned to either the control (existing care) or the intervention group and will be followed up for an average of 30 months. The total trial duration is about 3.5 years, from mid-August 2010 to December 31, 2013.


Options:
A: Inclusion Criteria:

* Adult patients \>= 25 years of age
* Type 2 diabetes for \>= 1 year
* Hemoglobin A1c \>= 7.5% and \<=11%
* Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic

Exclusion Criteria:

* Type 1 diabetes
* On any type of insulin therapy at start of study
B: Inclusion Criteria:

* Physician diagnosis of DM for more than 6 months;
* Glycated hemoglobin more than or equal to 8% within 3 months;
* Age:18-65 years.

Exclusion Criteria:

* Insulin pump users;
* Pregnant;
* Active substance, alcohol, or drug abuser;
* Psychotic or schizophrenic under active care;
* Severe hearing or visual impairment and other complications;
* Drug users (such as glucocorticoid or thyroid hormone) 3 months before the enrollment;
* No smartphone access.
C: Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of signing the informed consent

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Diagnosed with Type 1 diabetes
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients with known congenital heart disease/malformation
D: Inclusion Criteria:

1. Age 35 years and older
2. Confirmed diagnosis of diabetes based on documented evidence from oral glucose tolerance test or two venous fasting blood sugar levels or known diabetes patient on medication or insulin
3. Poor glycemic control (as evidenced by HbA1c \>=8.0%) and one or both of: dyslipidemia \[Low density Lipoprotein (LDL) \>=130 mg/dl\] or systolic hypertension \[Systolic Blood Pressure (SBP) \>=140 mmHg\], irrespective of lipid- or BP-lowering medication use, respectively
4. Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigator's assessment the patient is likely to follow-up regularly as required by the protocol.
5. Willingness to consent to randomization.

Exclusion Criteria:

Individuals will be excluded from participation if any of the following are present during screening:

1. Known type 1 diabetes mellitus
2. Diabetes secondary to chronic pancreatitis
3. Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
4. Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as evidenced by HbA1c \< 7.0%, SBP \< 130 mmHg, LDL-cholesterol \< 100 mg/dl \[LDL-cholesterol \< 70 mg/dl with history of CVD event\]) obtained from screening within a period not exceeding 28 days (4 weeks) prior to randomization
5. Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months
6. Current symptomatic Congestive Heart Failure (CHF) or New York Heart Association (NYHA) Class 3 or 4 effort intolerance
7. Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy \[dialysis or transplant\])
8. Transaminase \>3 times upper limit of normal OR active liver disease within past 2 years
9. Malignancy or life-threatening disease with death probable in 4 years
10. Any current medication (e.g. long-term steroids, protease inhibitors) that, in the opinion of the site investigator, would interfere with participant's diabetic status and follow-up
11. Any condition or circumstance that is unrelated to diabetes progression, that in the opinion of the site investigator would interfere with the participant's diabetic status and follow-up: including (but not limited to) other endocrinopathy \[adrenal, pituitary\], Tuberculosis (TB) patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, Body Mass index (BMI) \>= 45 kg/m2
12. On an investigational drug in the last 3 months
13. Currently participating in a clinical trial
14. No fixed address or contact details
15. Plans to move in the next 3 years
16. A member of the participant's household is currently in the trial
17. Inability or unwillingness of individual or legal guardian /representative to give written informed consent

Answer: D