Please select the eligibility criteria that correspond to the clinical trial below.
Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Brief Summary: Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.


Options:
A: 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
B: Inclusion criteria for participants:

* Type 2 diabetes mellitus
* Body mass index 25-39.9 kg/m2, irrespective of HbA1c status
* Able to give consent

Exclusion Criteria for participants:

* Diagnosis of cancer or another serious comorbidity
* Pharmacotherapy for weight loss or corticosteroids
* Pregnant women
* Blindness, amputation, foot ulcer or being on dialysis
* Be companion/team support for another participant in the trial

Inclusion criteria for the companion/team support:

* Available and committed to supporting the participant in achieving their goals
* Able to provide consent

Exclusion criteria for the companion/team support:

* Physical or mental condition that does not allow him to help the participant to achieve goals
C: Inclusion Criteria:

* Adults aged 30 yrs+ diagnosed with hypertension and /or diabetes who are able to give written consent (or verbal witnessed consent for illiterate patients).

Exclusion Criteria:

1. Patient requiring immediate referral to tertiary care due to accelerated hypertension, diabetic complications.
2. Patients with learning difficulties or vision/ hearing impairments but without a care giver making it impossible to use mobile phone.
3. Pregnant and lactating women.
D: Inclusion Criteria:

* Type 2 diabetes mellitus, diagnosis for \> 6 months.
* Age 18-65, participants of either gender- males or females.
* HbA1c between 7.5% and 12.5% within last 6 months (inclusive).
* On stable diabetes therapy for \>3 months prior to enrollment.
* Own an Android Smartphone.
* Participant willing to sign and date written Informed Consent Form to participate in the study.
* Willing to comply with the study schedule and procedures including randomization.

Exclusion Criteria:

* Previously used Gather Health
* Currently using an insulin pump or continuous glucose monitor.
* Pregnant or planning to become pregnant in the next 12 months.
* Severe hearing or visual impairment.
* Active substance, alcohol, or drug abuser (sober \<1 year).
* Any psychiatric illness including psychosis or schizophrenia that will impair the patient's ability to complete the study or follow study protocol.
* Recent major surgery or planning to have major surgery
* Significant renal, hepatic, or other disease that may impair patient's ability to complete the study or follow study protocol
* Using glucocorticoids
* Patients who have received or are planning to receive an organ transplant

Answer: C