Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
1 other identifier
interventional
118
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started May 2015
Shorter than P25 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedJuly 11, 2016
July 1, 2016
6 months
June 29, 2016
July 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Week 4 Change in Systolic Blood Pressure
4 weeks
Secondary Outcomes (22)
Change in Diastolic Blood Pressure
4 weeks
Proportion at blood pressure goal
4 weeks
Proportion at blood pressure goal
12 weeks
Change in Systolic Blood Pressure
12 weeks
Change in Diastolic Blood Pressure
12 weeks
- +17 more secondary outcomes
Other Outcomes (17)
Change in LDL in subjects using a statin
4 weeks
Change in LDL in subjects using a statin
12 weeks
Change in ACC/AHA ASCVD 10-year risk
4 weeks
- +14 more other outcomes
Study Arms (3)
DH-4
ACTIVE COMPARATORSubjects will use Proteus Discover, the digital health offering (DH) for 4 weeks
DH-12
ACTIVE COMPARATORSubjects will use Proteus Discover, the digital health offering (DH) for 12 weeks
Usual Care
OTHERSubjects received usual medical care including all normal interventions such as medication titration, adherence counseling, lifestyle coaching, and additional clinic visits per their providers' discretion.
Interventions
FDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application
Routine medical care including medication titration, adherence counseling, and lifestyle coaching.
Eligibility Criteria
You may qualify if:
- 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:
- SBP is ≥ 140 mm Hg (and his/her BP goal is \< 140/90 mm Hg).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Proteus Digital Health, Inc.lead
- Syneos Healthcollaborator
Related Publications (2)
Centers for Disease Control and Prevention (CDC). Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol--United States, 1999-2002 and 2005-200. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):109-14.
PMID: 21293326BACKGROUNDFrias J, Virdi N, Raja P, Kim Y, Savage G, Osterberg L. Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial. J Med Internet Res. 2017 Jul 11;19(7):e246. doi: 10.2196/jmir.7833.
PMID: 28698169DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Osterberg, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 11, 2016
Study Start
May 1, 2015
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
July 11, 2016
Record last verified: 2016-07