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

Abstract

BackgroundHypertension 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.ObjectiveThe 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.MethodsParticipants 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.ResultsFinal 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).ConclusionsFor 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.Trial RegistrationClinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF)

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“…The most commonly cited reasons for discontinuing participation (n = 20; 68.97%) were skin sensitivity secondary to wearing the sensor patch and/or difficulty with the patch adhering to the skin (ie, falling off frequently or having poor connectivity). This finding is consistent with previous studies studying the effectiveness of Proteus Discover in adult patients with hypertension and type 2 diabetes . Many children felt that wearing that patch was bothersome (57%), as did 50% of adolescents.…”

“…Advances in technology such as electronic monitoring have enabled providers and patients to better assess patterns of medication adherence and to personalize interventions toward targeted, patient‐specific medication‐taking behaviors . Electronic monitoring can be a more accurate way to capture data related to medication ingestion and, thus, has been described as a “gold standard” method to track medication adherence .…”

“…2,13,14 Advances in technology such as electronic monitoring have enabled providers and patients to better assess patterns of medication adherence and to personalize interventions toward targeted, patient-specific medication-taking behaviors. 15 Electronic monitoring can be a more accurate way to capture data related to medication ingestion and, thus, has been described as a "gold standard" method to track medication adherence. 2,16 Further, some electronic monitoring programs offer the added benefit of tracking medication dosages in real-time, allowing healthcare providers to promptly intervene at any indication of medication non-adherence.…”

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“…There are efforts underway to leverage data from wearable activity and heart rate monitors to predict numerous health-related behaviors and outcomes, including non-adherence [57, 58]. One study even used ingestible sensors detected by a small wearable patch in combination with a mobile device application and a provider portal [59•]. As has been previously noted, however, the benefit of digital health monitors will likely depend more on how these devices promote engagement and adherence than on the individual features of each monitor’s technology [60].…”

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“…The “digital divide” [9], the differential access to the internet and related technologies based on economic, geographic, and social factors, is an enormous barrier to the use of digital sensors and telehealth generally [10, 11]. One important study [5] in southern California that sought to empower individuals with uncontrolled hypertension and diabetes by using digital pills to track adherence, wearable sensors, and a mobile application enrolled 109 participants, of whom 46% were Hispanic, 57% had an income of less than USD 20,000, and 52% had a high school education or less. Studies like this will be important to demonstrate the value of these digital sensors for all [11].…”