Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes

Hypertension Clinical Trial

Official title:

Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827630
• Other study ID #: PB-DISC_CMB_01
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: July 5, 2016
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Proteus Digital Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

1. SBP is = 140 mm Hg (and his/her BP goal is < 140/90 mm Hg).

2. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Hypertension

Intervention

Other:
• Proteus Discover
FDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application
• Usual Care
Routine medical care including medication titration, adherence counseling, and lifestyle coaching.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Proteus Digital Health, Inc.	INC Research

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in LDL in subjects using a statin		4 weeks	No
Other	Change in LDL in subjects using a statin		12 weeks	No
Other	Change in ACC/AHA ASCVD 10-year risk		4 weeks	No
Other	Change in ACC/AHA ASCVD 10-year risk	American College of Cardiology/ American Heart Association Atherosclerotic Cardiovascular Disease Risk Score	12 weeks	No
Other	Change in Patient Activation Measure (PAM)	PAM is a validated measure of patient activation	4 weeks	No
Other	Change in Patient Activation Measure (PAM)	PAM is a validated measure of patient activation	12 weeks	No
Other	Resource Utilization: Summary of the number of outpatient visits, ER visits, and hospitalizations during the study	Data to be summarized descriptively	12 weeks	No
Other	Proportion of subjects with adequate activity and rest information while using Proteus Discover		4 weeks	No
Other	Proportion of subjects with adequate activity and rest information while using Proteus Discover		12 weeks	No
Other	Change in weight in kg		4 weeks	No
Other	Change in weight in kg		12 weeks	No
Other	Change in BMI in kg/m^2		4 weeks	No
Other	Change in BMI in kg/m^2		12 weeks	No
Other	Change in waist circumference (cm)		4 weeks	No
Other	Change in waist circumference (cm)		12 weeks	No
Other	Subject Reported Outcomes: Results from a subject satisfaction [to DH] questionnaire administered at the end of using DH.	Satisfaction (with Proteus Discover) survey administered upon completion of use of Proteus Discover	4 or 12 weeks	No
Other	Provider Reported Outcomes: Results from a provider satisfaction [to DH] questionnaire administered at the end of using DH.	Satisfaction (with Proteus Discover) survey administered upon completion of the study	4 or 12 weeks	No
Primary	Week 4 Change in Systolic Blood Pressure		4 weeks	No
Secondary	Change in Diastolic Blood Pressure		4 weeks	No
Secondary	Proportion at blood pressure goal	BP < 140/90 mmHg	4 weeks	No
Secondary	Proportion at blood pressure goal	BP < 140/90 mmHg	12 weeks	No
Secondary	Change in Systolic Blood Pressure		12 weeks	No
Secondary	Change in Diastolic Blood Pressure		12 weeks	No
Secondary	Change in fasting plasma glucose		4 weeks	No
Secondary	Change in fasting plasma glucose		12 weeks	No
Secondary	Change in glycated hemoglobin		12 weeks	No
Secondary	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 %.	4 weeks	No
Secondary	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 %.	4 to 12 weeks	No
Secondary	Average daily physical activity duration as measured by DH in DH-12 subjects		4 to 12 weeks	No
Secondary	Average daily rest duration as measured by DH in DH-12 subjects		4 to 12 weeks	No
Secondary	Average daily step count as measured by DH in DH-12 subjects		4 to 12 weeks	No
Secondary	Average daily step count as measured by DH in all DH subjects		4 weeks	No
Secondary	Average daily physical activity duration as measured by DH in all DH subjects		4 weeks	No
Secondary	Average daily rest duration as measured by DH in all DH subjects		4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	12 weeks	No
Secondary	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.	2 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	12 weeks	No
Secondary	Number of Treatment-Related Adverse Events	Descriptive summary of adverse events for DH arms versus usual care	12 weeks	Yes

External Links

•   American Diabetes Association. Statistics about diabetes.
•   Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014.