Frias Juan, Virdi Naunihal, Raja Praveen, Kim Yoona, Savage George, Osterberg Lars
National Research Institute, Los Angeles, CA, United States.
Proteus Digital Health, Redwood City, CA, United States.
J Med Internet Res. 2017 Jul 11;19(7):e246. doi: 10.2196/jmir.7833.
Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia.
The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app.
Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns.
Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean -21.8, SE 1.5 mm Hg vs mean -12.7, SE 2.8 mmHg; mean difference -9.1, 95% CI -14.0 to -3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82).
For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making.
Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF).
高血压和2型糖尿病是导致心脏、脑血管和肾脏疾病的主要可改变风险因素。疾病控制不佳的原因包括不依从、患者参与度不足和治疗惰性。
本研究旨在评估一种数字医疗产品（DMO）对诊所测量的血压（BP）和糖化血红蛋白（HbA1c）的影响，该产品使用数字药物（与可摄入传感器一起服用的药物）、可穿戴传感器贴片和移动设备应用程序来测量药物摄入依从性、身体活动和休息情况。
收缩压（SBP）≥140 mmHg且HbA1c≥7%、正在接受抗高血压治疗（≥2种药物）和口服糖尿病治疗但效果不佳的参与者被纳入这项三臂、12周、整群随机研究。参与者根据现场随机分组使用DMO（包括数字药物、可穿戴传感器贴片和移动设备应用程序）4周或12周，或接受常规护理。DMO组的医疗服务提供者可以通过网络门户查看DMO数据。在所有三个组中，医疗服务提供者被指示根据每次就诊时所有可用的临床信息做出医疗决策（药物滴定、依从性咨询、教育和生活方式指导）。主要结局是第4周时SBP的变化。其他结局包括第12周时SBP和HbA1c的变化，以及第4周和第12周时低密度脂蛋白胆固醇（LDL-C）和舒张压（DBP）的变化，以及第4周和第12周时达到血压目标（<140/90 mmHg）的患者比例、医疗决策和药物依从模式。
最终分析纳入了109名参与者（12个地点；年龄：平均58.7岁，标准差；女性：49.5%，54/109；西班牙裔：45.9%，50/109；收入≤20,000美元：56.9%，62/109；高中及以下学历：52.3%，57/109）。DMO组有80名参与者（7个地点），常规护理组有29名参与者（5个地点）。在第4周时，DMO导致SBP降低幅度在统计学上大于常规护理（平均-21.8，标准误1.5 mmHg，而平均-12.7，标准误2.8 mmHg；平均差异-9.1，95%可信区间-14.0至-3.3 mmHg），并在第12周时保持更大幅度的降低。与常规护理相比，DMO组在第4周和第12周时HbA1c、DBP和LDL-C降低幅度更大，达到血压目标的参与者比例更高。DMO组也比常规护理组接受了更多的治疗干预。使用DMO时药物依从性≥80%。最常见的不良事件是可穿戴传感器部位出现自限性皮疹（12%，10/82）。
对于高血压和糖尿病口服治疗效果不佳的患者，这种能够提供药物摄入依从性逐剂量反馈的DMO有助于降低血压、HbA1c和LDL-C，并促进患者参与和医疗服务提供者的决策。
Clinicaltrials.gov NCT02827630；https://clinicaltrials.gov/show/NCT02827630（由WebCite存档于http://www.webcitation.org/6rL8dW2VF）
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