Digital Medicines to Measure Drug Ingestion Adherence

Virdi, Naunihal

doi:10.1007/978-3-319-76593-8_7

Cited by 2 publications

(3 citation statements)

References 21 publications

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“…8 Proteus Discover Ò has also been extensively evaluated in other therapeutic areas, including hypertension, hypercholesterolemia, diabetes, heart failure, tuberculosis, HIV, and other diseases. 9 The objective of this study was to confirm that the rate and extent of absorption of TDF/FTC coencapsulated with Proteus Discover are unchanged relative to unencapsulated drug.…”

mentioning

confidence: 96%

Short Communication: Bioequivalence of Tenofovir and Emtricitabine After Coencapsulation with the Proteus Ingestible Sensor

Ibrahim

Brooks

Castillo‐Mancilla

et al. 2018

AIDS Research and Human Retroviruses

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Adherence to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, Truvada) is the primary determinant of HIV pre-exposure prophylaxis (PrEP) efficacy. Despite its importance, limitations exist in current methods of adherence quantification, restricting their implementation in the clinic. Proteus Discover (Proteus Digital Health) can measure the time of each dose using an ingestible sensor that is coencapsulated with medication. In this study, the bioequivalence of coencapsulated TDF/FTC with the Proteus sensor was compared relative to unencapsulated drug. This was a 1:1 randomized cross-over study in which healthy participants received a single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each period. Blood was collected at predose and at 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48, and 72 h postdose. Plasma concentrations were determined by LC-MS/MS methods, with a 10 ng/mL lower limit of quantitation (LLOQ) for both tenofovir (TFV) and FTC. Noncompartmental analysis was carried out with Phoenix WinNonlin for maximum concentrations (C), area under the concentration-time curve from time 0 to the last measured time point (AUC) and AUC extrapolated to infinity (AUC). Geometric mean ratios were calculated for each parameter and bioequivalence was defined as the 90% confidence interval (CI) of each ratio being within 80%-125%. Twenty-four participants (11 males; 19 white, 3 African American, and 2 Hispanic) completed both visits. Mean ± SD age was 28 ± 4 years and weight was 74 ± 14 kg. The 90% CIs for TFV C, AUC, and AUC were 89%-119%, 94%-111%, and 96%-111%, respectively. The 90% CIs for FTC C, AUC, and AUC were 96%-120%, 96%-108%, and 96%-108%, respectively. Bioequivalence was observed for the coencapsulation of TDF/FTC with the Proteus ingestible sensor, as assessed by a rigorously conducted pharmacokinetic study. Future studies will evaluate the utility and effectiveness of the sensor system as a tool to monitor PrEP adherence in clinical settings.

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mentioning

confidence: 96%

Short Communication: Bioequivalence of Tenofovir and Emtricitabine After Coencapsulation with the Proteus Ingestible Sensor

Ibrahim

Brooks

Castillo‐Mancilla

et al. 2018

AIDS Research and Human Retroviruses

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“…The functionality of personal area networks spans multiple domains, as represented in Figure 2: Inter body network integrates communication of Implantables and Ingestibles inside the body, or with a gateway on the body. As an example, Proteus Discover uses an ingestible sensor that communicates with a wearable sensor patch [35,36]. Body area networks/wireless body area networks integrate sensors on the body and sometimes in the body [37,38].…”

Section: Span: Synergy Of Information From Wearables and Iot Sensorsmentioning

confidence: 99%

“…Inter body network integrates communication of Implantables and Ingestibles inside the body, or with a gateway on the body. As an example, Proteus Discover uses an ingestible sensor that communicates with a wearable sensor patch [35,36].…”

Section: Span: Synergy Of Information From Wearables and Iot Sensorsmentioning

confidence: 99%

Wearables Meet IoT: Synergistic Personal Area Networks (SPANs)

Jovanov

2019

Sensors

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Wearable monitoring and mobile health (mHealth) revolutionized healthcare diagnostics and delivery, while the exponential increase of deployed “things” in the Internet of things (IoT) transforms our homes and industries. “Things” with embedded activity and vital sign sensors that we refer to as “smart stuff” can interact with wearable and ambient sensors. A dynamic, ad-hoc personal area network can span multiple domains and facilitate processing in synergistic personal area networks—SPANs. The synergy of information from multiple sensors can provide: (a) New information that cannot be generated from existing data alone, (b) user identification, (c) more robust assessment of physiological signals, and (d) automatic annotation of events/records. In this paper, we present possible new applications of SPANs and results of feasibility studies. Preliminary tests indicate that users interact with smart stuff—in our case, a smart water bottle—dozens of times a day and sufficiently long to collect vital signs of the users. Synergistic processing of sensors from the smartwatch and objects of everyday use may provide user identification and assessment of new parameters that individual sensors could not generate, such as pulse wave velocity (PWV) and blood pressure. As a result, SPANs facilitate seamless monitoring and annotation of vital signs dozens of times per day, every day, every time the smart object is used, without additional setup of sensors and initiation of measurements. SPANs creates a dynamic “opportunistic bubble” for ad-hoc integration with other sensors of interest around the user, wherever they go. Continuous long-term monitoring of user’s activity and vital signs can provide better diagnostic procedures and personalized feedback to motivate a proactive approach to health and wellbeing.

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Digital Medicines to Measure Drug Ingestion Adherence

Cited by 2 publications

References 21 publications

Short Communication: Bioequivalence of Tenofovir and Emtricitabine After Coencapsulation with the Proteus Ingestible Sensor

Short Communication: Bioequivalence of Tenofovir and Emtricitabine After Coencapsulation with the Proteus Ingestible Sensor

Wearables Meet IoT: Synergistic Personal Area Networks (SPANs)

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