Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects With Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- Week 4 Change in Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Week 4 Change in Systolic Blood Pressure
时间窗: 4 weeks
次要结局
- Change in Diastolic Blood Pressure(12 weeks)
- Proportion at blood pressure goal(12 weeks)
- Change in Systolic Blood Pressure(12 weeks)
- Average daily rest duration as measured by DH in DH-12 subjects(4 to 12 weeks)
- Change in fasting plasma glucose(12 weeks)
- Average Daily Medication Adherence as Measured by DH(4 to 12 weeks)
- Average daily physical activity duration as measured by DH in DH-12 subjects(4 to 12 weeks)
- Average daily step count as measured by DH in DH-12 subjects(4 to 12 weeks)
- Change in glycated hemoglobin(12 weeks)
- Average daily step count as measured by DH in all DH subjects(4 weeks)
- Average daily physical activity duration as measured by DH in all DH subjects(4 weeks)
- Average daily rest duration as measured by DH in all DH subjects(4 weeks)
- Table Summary of the Number of Subjects with Medication Changes(12 weeks)
- Table Summary of the Number of Subjects with Medical Decisions Other than Medication Changes(12 weeks)
- Number of Treatment-Related Adverse Events(12 weeks)