Hypertension Clinical Trial
Official title:
Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
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.
"Cardiometabolic diseases" as defined in this protocol refer to diseases that increase risk
for cardiovascular disease. Proteus® Digital Health is operationally defining
cardiometabolic (CMB) conditions for this study as including hypertension, type 2 diabetes,
and hypercholesterolemia. The prevalence of metabolic diseases is growing. Factors
contributing to this rise include the obesity epidemic and the aging population. 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.
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.
The study enrolled subjects with uncontrolled hypertension and type 2 diabetes failing at
least 2 antihypertensives and metformin and/or a sulfonylurea. 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.
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 randomized to usual care, received usual medical care such as medication changes,
adherence counseling, and lifestyle coaching. Providers could also schedule additional
visits without restrictions.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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