Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Brief Summary: The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.


Options:
A: Inclusion criteria:

* Diagnosis of type 2 Diabetes Mellitus
* Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
* Patients having BMI \> 25 Kg/m2;
* Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
* Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
* Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.

Exclusion criteria:

* Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
* History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
* Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
* Impaired renal function
* Impaired liver function
* History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation
* History of hypersensitivity to metformin;
* Pregnant or breast-feeding women, or women planning to become pregnant during the study;
* Failure to use adequate contraception (women of current reproductive potential only);
* Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases;
* History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse;
* Night shift workers;
* Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study;
* Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
* Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator or sponsor may interfere with the completion of the study;
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
* Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
* Previous enrolment in the present study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
B: Inclusion Criteria:

* Clinical diagnosis of Heart Failure (NYHA Class II-IV)
* Out-patients attending the University Health Network Heart Failure Clinic
* English-speaking and able to read English
* 18 years old or over

Exclusion Criteria:

* Awaiting heart transplantation
* Not expected to survive over a year (as determined by their cardiologist)
* Unable to read text on a mobile phone due to vision disability
* Unable to self-care due to anxiety, depression, or decreased cognitive function
* Lack of manual dexterity to accurately press buttons on the mobile phone
C: Inclusion Criteria:

1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
3. Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
4. At least 1 HF hospitalization within 12 months of Screening Visit
5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

Exclusion Criteria:

1. Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
5. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit
7. Subjects with congenital heart disease or mechanical right heart valve(s)
8. Subjects with known coagulation disorders
9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
D: Inclusion Criteria:

* Stroke or TIA in last 9 months
* Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication

Exclusion Criteria:

* Severe illness likely to dominate pattern of care
* Already using home blood pressure monitor
* Non-English speaking
* Severe cognitive impairment (AMTS\<7)
* Known secondary hypertension

Answer: B