HypertensionNCT02827630
Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
A study testing Proteus Discover in people with Hypertension and Diabetes Mellitus, Type 2, run by Proteus Digital Health, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2, Hypercholesterolemia
- What is being tested?
- Proteus Discover
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed description
"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.
- Being tested
- Proteus Discover, Usual Care
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteus DiscoverOther
FDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application
Usual CareOther
Routine medical care including medication titration, adherence counseling, and lifestyle coaching.
| Study group | Role | What they receive |
|---|---|---|
| DH-4 | Active comparator | Subjects will use Proteus Discover, the digital health offering (DH) for 4 weeks Receives: Other: Proteus Discover |
| DH-12 | Active comparator | Subjects will use Proteus Discover, the digital health offering (DH) for 12 weeks Receives: Other: Proteus Discover |
| Usual Care | Other | Subjects received usual medical care including all normal interventions such as medication titration, adherence counseling, lifestyle coaching, and additional clinic visits per their providers' discretion. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Week 4 Change in Systolic Blood Pressure
Measured: 4 weeks
Secondary outcomes (22)
Change in Diastolic Blood Pressure
Measured: 4 weeks
Proportion at blood pressure goal
BP < 140/90 mmHg
Measured: 4 weeks
Proportion at blood pressure goal
BP < 140/90 mmHg
Measured: 12 weeks
Change in Systolic Blood Pressure
Measured: 12 weeks
Change in Diastolic Blood Pressure
Measured: 12 weeks
Change in fasting plasma glucose
Measured: 4 weeks
Change in fasting plasma glucose
Measured: 12 weeks
Change in glycated hemoglobin
Measured: 12 weeks
Average Daily Medication Adherence as Measured by DH
Medication adherence by medication and overall (aggregate average of daily adherence to each of the medications) in all DH subjects. Reported as a %.
Measured: 4 weeks
Average Daily Medication Adherence as Measured by DH
Medication adherence by medication and overall (aggregate average of daily adherence to each of the medications) DH-12 subjects. Reported as a %.
Measured: 4 to 12 weeks
Average daily physical activity duration as measured by DH in DH-12 subjects
Measured: 4 to 12 weeks
Average daily rest duration as measured by DH in DH-12 subjects
Measured: 4 to 12 weeks
Average daily step count as measured by DH in DH-12 subjects
Measured: 4 to 12 weeks
Average daily step count as measured by DH in all DH subjects
Measured: 4 weeks
Average daily physical activity duration as measured by DH in all DH subjects
Measured: 4 weeks
Average daily rest duration as measured by DH in all DH subjects
Measured: 4 weeks
Table Summary of the Number of Subjects with Medication Changes
Summary table of the number of medication dose increases, medication dose decreases, medication stops, medication additions, and no change. Data was summarized separately for hypertension, type 2 diabetes, and hypercholesterolemia. Data to be collected on CRF. Data summarized by type of medication change.
Measured: 4 weeks
Table Summary of the Number of Subjects with Medication Changes
Summary table of the number of medication dose increases, medication dose decreases, medication stops, medication additions, and no change. Data was summarized separately for hypertension, type 2 diabetes, and hypercholesterolemia. Data to be collected on CRF. Data summarized by type of medication change.
Measured: 12 weeks
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Number of subjects who received adherence counseling, patient education, referral to a specialist, referral to disease management, lifestyle changes, and other medical decisions. Data summarized by type of decision.
Measured: 2 weeks
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Number of subjects who received adherence counseling, patient education, referral to a specialist, referral to disease management, lifestyle changes, and other medical decisions. Data summarized by type of decision.
Measured: 4 weeks
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Number of subjects who received adherence counseling, patient education, referral to a specialist, referral to disease management, lifestyle changes, and other medical decisions. Data summarized by type of decision.
Measured: 12 weeks
Number of Treatment-Related Adverse Events
Descriptive summary of adverse events for DH arms versus usual care
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteus Digital Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Lars Osterberg, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827630
- Sponsor's protocol ID
- PB-DISC_CMB_01
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21293326Frias 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.
PubMed 28698169
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
- ClinicalTrials.gov ID
- NCT02827630
- Acronym / sponsor ID
- PB-DISC_CMB_01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Proteus Digital Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DH-4 | Active comparator | Other: Proteus DiscoverSubjects will use Proteus Discover, the digital health offering (DH) for 4 weeks |
| DH-12 | Active comparator | Other: Proteus DiscoverSubjects will use Proteus Discover, the digital health offering (DH) for 12 weeks |
| Usual Care | Other | Other: Usual CareSubjects received usual medical care including all normal interventions such as medication titration, adherence counseling, lifestyle coaching, and additional clinic visits per their providers' discretion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteus DiscoverFDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application | Other | DH-12, DH-4 |
| Usual CareRoutine medical care including medication titration, adherence counseling, and lifestyle coaching. | Other | Usual Care |
Primary outcome
Week 4 Change in Systolic Blood Pressure
Time frame: 4 weeks
22 secondary outcomes
Change in Diastolic Blood Pressure
Time frame: 4 weeks
Proportion at blood pressure goal
Time frame: 4 weeks
Proportion at blood pressure goal
Time frame: 12 weeks
Change in Systolic Blood Pressure
Time frame: 12 weeks
Change in Diastolic Blood Pressure
Time frame: 12 weeks
Change in fasting plasma glucose
Time frame: 4 weeks
Change in fasting plasma glucose
Time frame: 12 weeks
Change in glycated hemoglobin
Time frame: 12 weeks
Average Daily Medication Adherence as Measured by DH
Time frame: 4 weeks
Average Daily Medication Adherence as Measured by DH
Time frame: 4 to 12 weeks
Average daily physical activity duration as measured by DH in DH-12 subjects
Time frame: 4 to 12 weeks
Average daily rest duration as measured by DH in DH-12 subjects
Time frame: 4 to 12 weeks
Average daily step count as measured by DH in DH-12 subjects
Time frame: 4 to 12 weeks
Average daily step count as measured by DH in all DH subjects
Time frame: 4 weeks
Average daily physical activity duration as measured by DH in all DH subjects
Time frame: 4 weeks
Average daily rest duration as measured by DH in all DH subjects
Time frame: 4 weeks
Table Summary of the Number of Subjects with Medication Changes
Time frame: 4 weeks
Table Summary of the Number of Subjects with Medication Changes
Time frame: 12 weeks
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Time frame: 2 weeks
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Time frame: 4 weeks
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Time frame: 12 weeks
Number of Treatment-Related Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Background: PubMed 21293326Centers 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.
- Derived from this study: PubMed 28698169Frias 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.
- American Diabetes Association. Statistics about diabetes.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Osterberg, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Proteus Discover in people with Hypertension and Diabetes Mellitus, Type 2, run by Proteus Digital Health, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Week 4 Change in Systolic Blood Pressure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827630, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.