Please select the eligibility criteria that correspond to the clinical trial below.
Title: Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
Brief Summary: The purpose of this study was to evaluate the efficacy of a new digital health offering, Proteus Discover to lower blood pressure and glycated hemoglobin in patients with uncontrolled hypertension and type 2 diabetes.


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:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of signing the informed consent

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Diagnosed with Type 1 diabetes
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients with known congenital heart disease/malformation
C: Inclusion Criteria:

* Veterans with type 2 diabetes managed for \> 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment.
* We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of \> 9.0% during the past year with no readings of \< 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.

Exclusion Criteria:

* Exclusion criteria will include lack of telephone access or severe hearing/ speech impairment that would limit:

  * telephone interaction
  * metastatic cancer
  * active psychosis documented in medical record
  * active alcohol or substance abuse
  * diagnosis of dementia
  * known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)
  * documented seizure history
  * documented history of severe complications of hypoglycemia (such as coma or seizure)
  * documented refusal or inability to perform self-monitoring of blood glucose
  * ongoing use of warfarin with prior history of major bleeding event
* Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous insulin infusion (insulin pumps) will not be eligible for this study.

  * Due to challenges with regulations regarding testing supplies pts will need to be taking insulin (a few patients had enrolled prior to this change.).
D: Inclusion Criteria:

* Patient with diagnosed diabetes
* Seen in the office of a participating family physician at least once between July 2009 and April 2010
* At high risk for cardiovascular events:

  * Previous cardiovascular disease (including AMI, angina, stroke, TIA, claudication); or
  * Men aged \>= 45 years, women aged \>= 50 years; or
  * Men aged \< 45 years, women aged \< 50 years with at least one of the following:

    1. Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease)
    2. Microvascular disease (nephropathy or retinopathy)
    3. Family history of premature coronary or cerebrovascular disease in a first-degree relative
    4. Duration of diabetes \> 15 years with age \> 30 years

Answer: A