Please select the eligibility criteria that correspond to the clinical trial below.
Title: Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse
Brief Summary: This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.


Options:
A: Inclusion Criteria:

* Adults (18 to 75 years old) who are diagnosed with essential hypertension and type 2 diabetes mellitus with or without hypercholesterolemia (defined as taking statin therapy).
* Both hypertension and diabetes are suboptimally controlled at Screening:

  1. SBP is ≥ 140 mm Hg (and his/her BP goal is \< 140/90 mm Hg).
  2. A1C is ≥ 7% and ≤ 11% at Screening (A1C is above goal by ≥ 0.5%).
* On a stable anti-hypertensive regimen (on current regimen for at least 30 days) with at least 2 anti-hypertensive medications
* Ability to manage the subject during the 12-week study with anti-hypertensive medication(s) and dose forms (or same drug classes and comparable doses for Usual Care subjects) used within the study.
* Currently on metformin and/or glipizide for diabetes for at least the past 60 days prior to Screening. Subjects can be managed on other noninsulin diabetes medicines (including sulfonylureas other than glipizide) during the study.
* Subjects must have a Proteus test pill (IS used to test that the Proteus Patch is correctly placed on the body and paired with the mobile device) detected as part of onboarding on the Proteus device (during the Proteus Onboarding Visit).
* In the Investigator's opinion inadequate medication adherence is a potential factor in the subject's uncontrolled hypertension or diabetes.

Exclusion Criteria:

* BMI \> 40 kg/m2 as subjects may be more likely to have secondary reasons for out of control blood pressure (BP) and/or diabetes.
* History of skin sensitivity to adhesive medical tape or metals for subjects in the Intervention Arms.
* History of acute or chronic dermatitis for subjects in the Intervention Arms.
* Any condition that in the investigator's opinion could preclude safe participation in the study.
* Secondary cause for hypertension (eg, renal impairment or renal artery stenosis) or uncontrolled diabetes (eg, corticosteroid use).
* Mean SBP ≥ 180 mm Hg and/or DBP ≥ 110 mm Hg, if associated with evidence of hypertensive emergency..
* Current or recent (within past year) treatment with insulin or other injectables for diabetes.
B: Inclusion Criteria:

* Type 2 diabetes
* Recent control obtain (HbA1c\<8%) after diabetes improvement program
* Receives care in primary care clinic

Exclusion Criteria:

* pregnant
C: Inclusion Criteria:

* Subjects will be those patients with diabetes who speak English and/or Spanish and reside in the South Bronx.
* Subjects will be adults, \> 18 years, with diabetes, who become part of the NYC registry by virtue of having a reported HbA1c \>7% to the DOHMH.
* The sampling frame for this study comprises virtually all adults with diabetes in the South Bronx.

Exclusion Criteria:

* Age \< 18 years
* A1c \< = 7 %
* Refuses informed consent and HIPAA consent
* Cognitive dysfunction as assessed by telephone
* Does not read or speak English or Spanish
* No diabetes
D: Inclusion Criteria:

* Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment. This will be determined via self-report with verification (medical records, current treatment, or test results meeting the 2009 Malaysian Clinical Practice Guideline for Management of Type 2 Diabetes Mellitus (4th edition) criteria of fasting blood glucose \> 7.0 mmol/L , symptoms of hyperglycaemia with casual plasma glucose \>11.1mmol/L or two-hour plasma glucose \>11.1mmol/L after a 75gram oral glucose load)
* HbA1c of \> 7.5% but less than 11.0% within the most recent 3 months. Individuals with HbA1c exceeding this level may require more urgent care and as such will be asked to seek treatment
* Aged 18 - 75 years are eligible. Participants older than 75 years of age are excluded due to the increased risk of competing mortality and potential safety concerns related to hypoglycaemia
* Willing or has an intention to fast for at least 15 days during Ramadan
* Access to internet and an e-mail address , or access to a smartphone with 3G services in the intervention group
* Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation

Exclusion Criteria:

* Unable or unwilling to give informed consent or communicate with local study staff
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
* Hospitalization for depression in past six months
* Plans to relocate to an area or travel plans that do not permit full participation in the study
* Lack of support from primary health care provider or family members
* History of bariatric surgery, small bowel resection, or extensive bowel resection
* Currently pregnant or nursing
* Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
* Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Answer: B