Clinical Trial: Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

"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 m
Sponsor: Proteus Digital Health, Inc.

Current Primary Outcome: Week 4 Change in Systolic Blood Pressure [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Diastolic Blood Pressure [ Time Frame: 4 weeks ]
  • Proportion at blood pressure goal [ Time Frame: 4 weeks ]
    BP < 140/90 mmHg
  • Proportion at blood pressure goal [ Time Frame: 12 weeks ]
    BP < 140/90 mmHg
  • 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 ]
    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 [ Time Frame: 4 to 12 weeks ]
    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 [ 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 ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 2 weeks ]
    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 [ Time Frame: 4 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    Descriptive summary of adverse events for DH arms versus usual care


Original Secondary Outcome: Same as current

Information By: Proteus Digital Health, Inc.

Dates:
Date Received: June 29, 2016
Date Started: May 2015
Date Completion:
Last Updated: July 5, 2016
Last Verified: July 2016