First Use of an Ingestible Sensor to Manage Uncontrolled Blood Pressure in Primary Practice: The UK Hypertension Registry

R, Naik; Macey, Neil; Rj, West; Godbehere, Peter; Sc, Thurston; Fox, Robin; Xiang, Weina; Kim, Yonggyun; Singh, I; S, Leadley; DiCarlo, Lorenzo A.

doi:10.4172/2161-0711.1000506

Cited by 8 publications

(6 citation statements)

References 10 publications

(7 reference statements)

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“…The included studies tested DP with patients having a wide range of conditions or illnesses. In total, the 18 studies included 896 participants ranging from 5 [34] to 151 [44]. Six studies included patients with uncontrolled hypertension, where DP were co-encapsulated with different types of traditional medications belonging, for example, to the category of beta-blockers or angiotensinconverting-enzyme inhibitors.…”

Section: Yesmentioning

confidence: 99%

“…Many papers (n = 10) reflect on the usability of DP and generally underscore that patients give positive feedback concerning the functional aspects of this technology. For instance, one study [44] claims that "ninety-two percent (92%) of patients reported that they did not mind wearing the wearable sensor. More than 87% of patients reported having a good experience from using the ingestible [sic] and thought that it was easy to understand and convenient to use".…”

Section: Patient-relatedmentioning

confidence: 99%

“…Almost all the records (n = 14) explain that data collection and data transmission are safe and secure, mentioning, for example, that personal information is encrypted [38] or that a secure server is used [39]. Some papers (n = 9) also refer to privacy considerations, by underlining the vast amount of personal data that are collected [34], by reporting that these data are collected in a private way as data transmission is confined to the body of patients [32], who are anyway fully aware of being monitored [44]. In one study testing DP with opioids medication given to patients suffering from acute fractures [37], it is argued that "formative interviews of study participants demonstrate their perception that the digital pill maintains patient privacy.…”

Section: Patient-relatedmentioning

confidence: 99%

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Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects

et al. 2020

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Background: Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients' physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine. Methods: To map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP. Results: Our search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users' interaction with DP, personal sphere, health-related risks and patients' benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine. Conclusions: We conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution.

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Section: Yesmentioning

confidence: 99%

Section: Patient-relatedmentioning

confidence: 99%

Section: Patient-relatedmentioning

confidence: 99%

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Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects

et al. 2020

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“…A prior hypertension registry study conducted in several primary care centers in the United Kingdom demonstrated the ability of a prior version of the DMO with no patient feedback (ie, digital medicines plus patch) to uncover a root cause for uncontrolled HTN in all participants after 2 weeks of use. Additionally, 37% of participants achieved BP control after 2 weeks with no adjustments to their antihypertensive medications [20]. …”

Section: Introductionmentioning

confidence: 99%

“…The design of the HTN registry was used to determine the duration of DMO use in this study; the first 2 weeks of DMO use allowed providers to understand the root cause for elevated BP (nonadherence, inadequate medication, or both) and the subsequent 2 weeks allowed the provider to see the effect of the medical decision on BP after the first 2 weeks [20]. The primary objective was to study the effect of the DMO on BP.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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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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Digital Medicines to Measure Drug Ingestion Adherence

Virdi

2018

Drug Adherence in Hypertension and Cardiovascular Protection

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First Use of an Ingestible Sensor to Manage Uncontrolled Blood Pressure in Primary Practice: The UK Hypertension Registry

Cited by 8 publications

References 10 publications

Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects

Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects

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

Digital Medicines to Measure Drug Ingestion Adherence

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