Clinical trial NCT02827630: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus, Type 2
Hypercholesterolemia
Lead sponsor: Proteus Digital Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2016-07-11
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Week 4 Change in Systolic Blood Pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Diastolic Blood Pressure
timeFrame: 4 weeks
measure: Proportion at blood pressure goal
timeFrame: 4 weeks
measure: Proportion at blood pressure goal
timeFrame: 12 weeks
measure: Change in Systolic Blood Pressure
timeFrame: 12 weeks
measure: Change in Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Change in fasting plasma glucose
timeFrame: 4 weeks
measure: Change in fasting plasma glucose
timeFrame: 12 weeks
measure: Change in glycated hemoglobin
timeFrame: 12 weeks
measure: Average Daily Medication Adherence as Measured by DH
timeFrame: 4 weeks
measure: Average Daily Medication Adherence as Measured by DH
timeFrame: 4 to 12 weeks
measure: Average daily physical activity duration as measured by DH in DH-12 subjects
timeFrame: 4 to 12 weeks
measure: Average daily rest duration as measured by DH in DH-12 subjects
timeFrame: 4 to 12 weeks
measure: Average daily step count as measured by DH in DH-12 subjects
timeFrame: 4 to 12 weeks
measure: Average daily step count as measured by DH in all DH subjects
timeFrame: 4 weeks
measure: Average daily physical activity duration as measured by DH in all DH subjects
timeFrame: 4 weeks
measure: Average daily rest duration as measured by DH in all DH subjects
timeFrame: 4 weeks
measure: Table Summary of the Number of Subjects with Medication Changes
timeFrame: 4 weeks
measure: Table Summary of the Number of Subjects with Medication Changes
timeFrame: 12 weeks
measure: Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
timeFrame: 2 weeks
measure: Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
timeFrame: 4 weeks
measure: Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes
timeFrame: 12 weeks
measure: Number of Treatment-Related Adverse Events
timeFrame: 12 weeks
Other outcomes:
measure: Change in LDL in subjects using a statin
timeFrame: 4 weeks
measure: Change in LDL in subjects using a statin
timeFrame: 12 weeks
measure: Change in ACC/AHA ASCVD 10-year risk
timeFrame: 4 weeks
measure: Change in ACC/AHA ASCVD 10-year risk
timeFrame: 12 weeks
measure: Change in Patient Activation Measure (PAM)
timeFrame: 4 weeks
measure: Change in Patient Activation Measure (PAM)
timeFrame: 12 weeks
measure: Resource Utilization: Summary of the number of outpatient visits, ER visits, and hospitalizations during the study
timeFrame: 12 weeks
measure: Proportion of subjects with adequate activity and rest information while using Proteus Discover
timeFrame: 4 weeks
measure: Proportion of subjects with adequate activity and rest information while using Proteus Discover
timeFrame: 12 weeks
measure: Change in weight in kg
timeFrame: 4 weeks
measure: Change in weight in kg
timeFrame: 12 weeks
measure: Change in BMI in kg/m^2
timeFrame: 4 weeks
measure: Change in BMI in kg/m^2
timeFrame: 12 weeks
measure: Change in waist circumference (cm)
timeFrame: 4 weeks
measure: Change in waist circumference (cm)
timeFrame: 12 weeks
measure: Subject Reported Outcomes: Results from a subject satisfaction [to DH] questionnaire administered at the end of using DH.
timeFrame: 4 or 12 weeks
measure: Provider Reported Outcomes: Results from a provider satisfaction [to DH] questionnaire administered at the end of using DH.
timeFrame: 4 or 12 weeks
Locations:
Study officials:
affiliation: Stanford University
name: Lars Osterberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.