Individual Study / Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes

Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes

Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes

Initiatives -
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.
Start Year
2015
Funding
Proteus Digital Health, Inc.

Design

Study design
Clinical trial cohort

Marker Paper

https://clinicaltrials.gov/ct2/show/NCT02827630

PUBMED

Number of participants

Number of participants
118
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

The study enrolled subjects with uncontrolled hypertension and type 2 diabetes failing at least 2 antihypertensives and metformin and/or a sulfonylurea.
Selection Criteria
Minimum age
18
Maximum age
75
Newborns
Twins
Countries
  • United States of America
Ethnic Origin
Health Status
  • hypertension and type 2 diabetes.
Other criteria
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.

Recruitment

Sources of recruitment
  • Clinical patients

Number of participants

Number of participants
118
Number of participants with biosamples
Data Collection Event
Proteus® Digital Health is operationally defining cardiometabolic (CMB) conditions for this study as including hypertension, type 2 diabetes, and hypercholesterolemia.
Start Date
2015-05
End Date
2016-01
Data sources
  • Smart sensors
    • Ingestible sensors