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Secondary cause for hypertension (eg, renal impairment or renal artery stenosis) or uncontrolled diabetes (eg, corticosteroid use).Any condition that in the investigator's opinion could preclude safe participation in the study.History of acute or chronic dermatitis for subjects in the Intervention Arms.
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History of skin sensitivity to adhesive medical tape or metals for subjects in the Intervention Arms.SBP is ≥ 140 mm Hg (and his/her BP goal is 40 kg/m2 as subjects may be more likely to have secondary reasons for out of control blood pressure (BP) and/or diabetes.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).īoth hypertension and diabetes are suboptimally controlled at Screening:.Providers could also schedule additional visits without restrictions. Subjects randomized to usual care, received usual medical care such as medication changes, adherence counseling, and lifestyle coaching. Subjects randomized to the intervention arms, used a digital health offering to (1) provide automatic and passive electronic documentation of medication adherence and patterns of medication taking, (2) assist providers in distinguishing inadequate medication adherence or pharmacologic unresponsiveness as the root cause for uncontrolled hypertension and type 2 diabetes, and (3) inform management decisions (dose adjustment, medication addition or substitution, adherence counseling, referral to a hypertension specialist). Subjects were randomized to one of 3 arms: use of Proteus Discover for 4 weeks, use of Proteus Discover for 12 weeks, or usual care. The study enrolled subjects with uncontrolled hypertension and type 2 diabetes failing at least 2 antihypertensives and metformin and/or a sulfonylurea. The purpose of the study was to evaluate the ability of a new digital health offering, Proteus Discover to lower blood pressure and glycated hemoglobin in patients with uncontrolled hypertension and type 2 diabetes. In particular, because of the costs and risk of complications associated with diabetes and hypertension, many health systems and payers are increasing focus on interventions to reduce the burden of these diseases. Factors contributing to this rise include the obesity epidemic and the aging population. The prevalence of metabolic diseases is growing.
Proteus® Digital Health is operationally defining cardiometabolic (CMB) conditions for this study as including hypertension, type 2 diabetes, and hypercholesterolemia. "Cardiometabolic diseases" as defined in this protocol refer to diseases that increase risk for cardiovascular disease.
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