Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
Initiatives
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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
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.
Selection Criteria
- Minimum age
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18
- Maximum age
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75
- Newborns
- Twins
- Countries
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- United States of America
- Ethnic Origin
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- Health Status
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- 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
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- 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
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2015-05
- End Date
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2016-01
- Data sources
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Smart sensors
- Ingestible sensors
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Smart sensors