Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
Brief Summary: Objective:

* To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
* To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.

Methodology:

Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.


Options:
A: Inclusion Criteria:

Uninsured subjects aged 2:40 years who live in the catchment area of the participating primary care clinics with a mobile for personal use and a 10-year CVD risk of;:;: 10%, as classified by a community health worker.

Exclusion Criteria:

Pregnant women, bed-bound illiterate and persons who cannot give informed consent, or are planning to move away from the vicinity of the clinic in the following year will be excluded.
B: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus (the onset of diabetes must have occurred on or after the age of 30 years and there is no history of diabetic ketoacidosis)
* Uncontrolled systolic hypertension (defined as a daytime systolic BP of 130 mm Hg or higher on 24-hour ambulatory)

Exclusion Criteria:

* Conditions making the patient unsuitable for study such as severe cognitive impairment, language difficulties (unable to speak and understand instructions in English), frequent (more than once per month for more than week) or prolonged (more than 2 months) trips away from home, homelessness, self-identified substance abuse, being pregnant, or unable to use home BP device;
* Life expectancy less than one year
* Coexisting conditions that require frequent (more than once a month) office visits or repeated (more than once in the past year) hospitalizations
* Atrial fibrillation or other cardiac arrhythmias requiring drug treatment
* Moderately severe chronic renal failure defined as estimated GFR less than 25 mL/min
* Myocardial infarction, episode of heart failure requiring hospitalization, or paralyzing stroke in the past year
* Having unstable angina
* Severe valvular heart diseases such as severe aortic stenosis
* Symptomatic orthostatic hypotension
* Refusal to sign consent form or to carry out the demands made by the study
C: Inclusion Criteria:

1. Heart failure (I50, NYHA II-IV) or atrial fibrillation (I48, EHRA II-IV) or resistant hypertension (I10-15, ≥ 3 antihypertensive medicines from different drug classes, SBP \> 140 /90mmHg or ≥ 4 antihypertensives irrespective of the blood pressure, with at least one drug being a diuretic).
2. Member of health insurance company AOK Nordost or Techniker Krankenkasse (TK).
3. Inscription to integrated care contract with the health insurance company.
4. Residence in Mecklenburg-Vorpommern.
5. Age ≥ 18 years.
6. Written informed consent.

Exclusion Criteria:

1. Pregnancy, suspected pregnancy or breast-feeding period.
2. Participation in another clinical trial up to 30 days before inclusion in this trial.
3. Cognitive deficits: patients need to be able to read and understand German language as presented on a tablet.
4. Chronic kidney disease requiring dialysis or creatinine clearance \< 15 ml/min.
D: Inclusion Criteria:

Patients:

* T2DM diagnosis
* aged between 18 and 65

Health professionals:

* primary health care teams (PHCT) comprising a primary care physician and a nurse practitioner associated to a patient will be selected
* must have a permanent position or a stable substitute position

Exclusion Criteria:

* peripheral vascular disease
* diabetic nephropathy and/or chronic kidney disease
* cognitive impairment, dementia
* major depression
* insufficient level of Spanish
* to be pregnant or planning to become pregnant in the next 6 months
* cancer last 5 years
* ischemic disease or heart failure
* proliferative diabetic retinopathy

Answer: D