Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter, Randomized Trial Designed to Evaluate the Applicability of the Guidelines of the Italian Society of Diabetology for the Prevention of Cardiovascular Diseases in Type 2 Diabetes
Brief Summary: Despite several clinical trials have clearly demonstrated that the correction of a single cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study has been evaluating the effect of a multifactorial intervention strategy on macrovascular complications of diabetes. For this reason, the disease management approach currently endorsed by international guidelines (i.e correction of all major CVD risk factors to target levels usually lower than lower risk populations) has not been extensively investigated in terms of prevalence of application in current clinical practice and in terms of real efficacy.

The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of: (1) investigating the degree of application of the international guidelines for CVD prevention in type 2 diabetic patients and (2) verifying whether the application of an intensive multi-factorial intervention inspired by these guidelines is feasible and effective in decreasing the incidence of new CVD events.


Options:
A: Inclusion Criteria:

* Both genders
* age 50-70 years
* Type two diabetes with at least two-year history of disease and without insulin treatment in the first two years after diagnosis
* Negative medical history for documented previous cardiovascular events or macrovascular complications
* Written consent to participate
* Presence of at least 2 of the following risk factors:

  * LDL cholesterol \> 130 mg/dL (regardless of treatment)
  * Triglycerides \> 200 mg/dL
  * HDL cholesterol \< 35 (males) or 45 (females) mg/dL
  * Blood pressure \> 140/90 mmHg
  * Cigarette smoking

Exclusion Criteria:

* Age below 50 or above 70 years
* Type 1 diabetes, diagnosis before 40 years of age, known presence of auto-antibodies or insulin requirement in the first 2 years of disease.
* Chronic kidney failure (plasma creatinine \> 2 mg/dL)
* Significant liver damage (AST and/or ALT \> 2 times the upper limits of normality)
* History of previous cardiovascular events
* Active neoplasms or any concomitant disease limiting life expectancy
B: Study subjects include up to 700 first, second, third, and fourth year primary care residents from a minimum of 20 residency programs across the country. To become a partner in this study, programs must meet the eligibility criteria listed below:

To be eligible for partnership in this study, a program must meet all the following criteria:

a) be an accredited family medicine or internal medicine/med-peds training program within the U.S., (b) have a minimum of 12 residents within the standard 3- to 4-year program, (c) the program director must endorse and be willing to offer SimCare Diabetes to all residents within the program and provide residents (with help from the study staff) with the explanatory and registration materials, (d) the residency program director must sign a letter of agreement with the research team specifying the responsibilities of the research team and of the residency program in addressing the specific needs of this project, (e) the residency program director must agree to complete a residency program director survey, which provides insight into the general characteristics of the residency program, and provide diabetes quality measurement data from at least one resident ambulatory clinic pre-intervention (around October/November 2010) and post-intervention (around June/July 2011), (f) residents within the program must have high speed internet access, and (g) if randomized to the delayed learning program group, the program must be willing to postpone SimCare Diabetes until after the post-intervention assessment cases are completed.
C: 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
D: Inclusion Criteria:

* \>= 18 years of age
* Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
* Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
* Diagnosis of diabetes
* Baseline A1C \>= 7.5%

Exclusion Criteria:

* Initial diagnosis of diabetes within the last 12 months
* Diagnosis of Type 1 diabetes
* Inability to speak and read in English
* Lack of regular access to a computer with Internet and email capabilities
* Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
* Pregnant, planning to become pregnant, or lactating
* Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere
* PCP determination that the study is inappropriate or unsafe for the patient
* Investigator discretion for clinical safety or protocol adherence reasons

Answer: A