Back to resultsProteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
Primary Purpose
Hypertension, Diabetes Mellitus, Type 2, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proteus Discover
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
DH-4
DH-12
Usual Care
Arm Description
Subjects will use Proteus Discover, the digital health offering (DH) for 4 weeks
Subjects will use Proteus Discover, the digital health offering (DH) for 12 weeks
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.
Outcomes
Primary Outcome Measures
Week 4 Change in Systolic Blood Pressure
Secondary Outcome Measures
Change in Diastolic Blood Pressure
Proportion at blood pressure goal
BP < 140/90 mmHg
Proportion at blood pressure goal
BP < 140/90 mmHg
Change in Systolic Blood Pressure
Change in Diastolic Blood Pressure
Change in fasting plasma glucose
Change in fasting plasma glucose
Change in glycated hemoglobin
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 %.
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 %.
Average daily physical activity duration as measured by DH in DH-12 subjects
Average daily rest duration as measured by DH in DH-12 subjects
Average daily step count as measured by DH in DH-12 subjects
Average daily step count as measured by DH in all DH subjects
Average daily physical activity duration as measured by DH in all DH subjects
Average daily rest duration as measured by DH in all DH subjects
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.
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.
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.
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.
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.
Number of Treatment-Related Adverse Events
Descriptive summary of adverse events for DH arms versus usual care
Full Information
NCT ID
NCT02827630
First Posted
June 29, 2016
Last Updated
July 5, 2016
Sponsor
Proteus Digital Health, Inc.
Collaborators
Syneos Health
1. Study Identification
Unique Protocol Identification Number
NCT02827630
Brief Title
Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
Official Title
Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proteus Digital Health, Inc.
Collaborators
Syneos Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Type 2, Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DH-4
Arm Type
Active Comparator
Arm Description
Subjects will use Proteus Discover, the digital health offering (DH) for 4 weeks
Arm Title
DH-12
Arm Type
Active Comparator
Arm Description
Subjects will use Proteus Discover, the digital health offering (DH) for 12 weeks
Arm Title
Usual Care
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proteus Discover
Intervention Description
FDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Routine medical care including medication titration, adherence counseling, and lifestyle coaching.
Primary Outcome Measure Information:
Title
Week 4 Change in Systolic Blood Pressure
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Diastolic Blood Pressure
Time Frame
4 weeks
Title
Proportion at blood pressure goal
Description
BP < 140/90 mmHg
Time Frame
4 weeks
Title
Proportion at blood pressure goal
Description
BP < 140/90 mmHg
Time Frame
12 weeks
Title
Change in Systolic Blood Pressure
Time Frame
12 weeks
Title
Change in Diastolic Blood Pressure
Time Frame
12 weeks
Title
Change in fasting plasma glucose
Time Frame
4 weeks
Title
Change in fasting plasma glucose
Time Frame
12 weeks
Title
Change in glycated hemoglobin
Time Frame
12 weeks
Title
Average Daily Medication Adherence as Measured by DH
Description
Medication adherence by medication and overall (aggregate average of daily adherence to each of the medications) in all DH subjects. Reported as a %.
Time Frame
4 weeks
Title
Average Daily Medication Adherence as Measured by DH
Description
Medication adherence by medication and overall (aggregate average of daily adherence to each of the medications) DH-12 subjects. Reported as a %.
Time Frame
4 to 12 weeks
Title
Average daily physical activity duration as measured by DH in DH-12 subjects
Time Frame
4 to 12 weeks
Title
Average daily rest duration as measured by DH in DH-12 subjects
Time Frame
4 to 12 weeks
Title
Average daily step count as measured by DH in DH-12 subjects
Time Frame
4 to 12 weeks
Title
Average daily step count as measured by DH in all DH subjects
Time Frame
4 weeks
Title
Average daily physical activity duration as measured by DH in all DH subjects
Time Frame
4 weeks
Title
Average daily rest duration as measured by DH in all DH subjects
Time Frame
4 weeks
Title
Table Summary of the Number of Subjects with Medication Changes
Description
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.
Time Frame
4 weeks
Title
Table Summary of the Number of Subjects with Medication Changes
Description
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.
Time Frame
12 weeks
Title
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Description
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.
Time Frame
2 weeks
Title
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Description
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.
Time Frame
4 weeks
Title
Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
Description
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.
Time Frame
12 weeks
Title
Number of Treatment-Related Adverse Events
Description
Descriptive summary of adverse events for DH arms versus usual care
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in LDL in subjects using a statin
Time Frame
4 weeks
Title
Change in LDL in subjects using a statin
Time Frame
12 weeks
Title
Change in ACC/AHA ASCVD 10-year risk
Time Frame
4 weeks
Title
Change in ACC/AHA ASCVD 10-year risk
Description
American College of Cardiology/ American Heart Association Atherosclerotic Cardiovascular Disease Risk Score
Time Frame
12 weeks
Title
Change in Patient Activation Measure (PAM)
Description
PAM is a validated measure of patient activation
Time Frame
4 weeks
Title
Change in Patient Activation Measure (PAM)
Description
PAM is a validated measure of patient activation
Time Frame
12 weeks
Title
Resource Utilization: Summary of the number of outpatient visits, ER visits, and hospitalizations during the study
Description
Data to be summarized descriptively
Time Frame
12 weeks
Title
Proportion of subjects with adequate activity and rest information while using Proteus Discover
Time Frame
4 weeks
Title
Proportion of subjects with adequate activity and rest information while using Proteus Discover
Time Frame
12 weeks
Title
Change in weight in kg
Time Frame
4 weeks
Title
Change in weight in kg
Time Frame
12 weeks
Title
Change in BMI in kg/m^2
Time Frame
4 weeks
Title
Change in BMI in kg/m^2
Time Frame
12 weeks
Title
Change in waist circumference (cm)
Time Frame
4 weeks
Title
Change in waist circumference (cm)
Time Frame
12 weeks
Title
Subject Reported Outcomes: Results from a subject satisfaction [to DH] questionnaire administered at the end of using DH.
Description
Satisfaction (with Proteus Discover) survey administered upon completion of use of Proteus Discover
Time Frame
4 or 12 weeks
Title
Provider Reported Outcomes: Results from a provider satisfaction [to DH] questionnaire administered at the end of using DH.
Description
Satisfaction (with Proteus Discover) survey administered upon completion of the study
Time Frame
4 or 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Osterberg, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21293326
Citation
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.
Results Reference
background
PubMed Identifier
28698169
Citation
Frias 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.
Results Reference
derived
Learn more about this trial
Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
We'll reach out to this number within 24 hrs