What is the Current Status of Bioingestible Sensors for Medication Adherence?

Leveraging technology to track and intervene on patients' medication adherence has been the subject of numerous studies. Sensors that can be attached to insulin pens, smart auto-injectors for patients with MS, sensors for inhalers, smart pill bottles, and bioingestible sensors are some of the evolving technologies.

Studies have focused on all of these areas, with pros and cons of their usage being evaluated for patient care integration. However, there has not been a blockbuster up to this point, leaving the market wide open for novel startups to create digital health interventions.

The bioingestible sensor space has recently seen big news with the only 2 companies in the market.

etectRx (formerly EtectBio) received FDA clearance on their ID-Cap® System in December 2019.¹ This system allows a medication—tablet or capsule—to be co-encapsulated into a capsule with a sensor called an ID-Capsule. When swallowed, it will dissolve, and send out a signal through RFID to an external receiver that a patient is wearing, such as an ID-Cap Reader, a device on a lanyard worn around the neck. This ingestion data is then forwarded to the user's smartphone to sync the data, which can then be shared with others, such as a patient's provider.

In a clinical study of 180 patients, the ID-Cap® System will be utilized to create a record of adherence for more than 20,000 doses of HIV medication. The study is being conducted at the University of Colorado Anschutz Medical Campus in partnership with the National Institutes of Health.²

Proteus Digital Health, another company that makes a bioingestible sensor detected with a worn patch on the user, brought to market with Otsuka Pharmaceuticals the first 'smart' pill, Abilify MYCITE, 2 years ago. This product is focused on patients with schizophrenia, major depressive disorder, and bipolar disorder. However, Proteus has recently had financial difficulties, and is reportedly undergoing a period of restructure.³

Bioingestible sensors can play a significant role in several conditions, such as mental health, infectious disease (e.g., HIV, TB, Hepatitis), and oral oncology. This is due to several factors, including patient disposition, drug costs, and public health concerns. We have seen both etectRx and Proteus Digital Health conduct studies in these spaces, and there have been takeup from some payors, health system pharmacies, pharma, and researchers.

Nonetheless, bioingestible sensors, and perhaps all medication adherence technology, focus primarily on adherence itself. Digital health offers a novel opportunity to have larger insights on patients' characteristics than we could in the past. This includes their medication-taking behavior, but also other factors that can be gathered from wearables or other ancillary sensors. Bioingestible sensors offered perhaps 1 of the first realistic objective measurements of medication adherence in the patient home setting for oral medications.

I think it would be amazing to quantify how adherence, and medication delivery could be utilized with other data to monitor therapeutic outcomes, and patient safety concerns. One example is the nature of sleep, with Z-drugs having a high utilization but with concern around patient falls.

Could we reach the point and say, "look, you take your medication at 8 pm, but are on your phone until 10 pm, and then you still get up at night several times," which could help us figure out if it is a sleep hygiene issue or that the medication is not the best for the patient, and something else could be used. This could all be accomplished in real time, negating a patient logistical burden of coming back to a clinic several weeks later to self-report their own subjective history for a clinician to make a therapeutic decision upon.

etectRx will be another option for how we approach medication adherence, and pharmacists and other health care providers need to start thinking about means of leveraging the data other than saying the patient took their pills. Major AI (artificial intelligence) and data analytics technology can really elevate how we optimize patients' medications, and this is 1 tool that can help us in the future. We just need to be prepared to handle that responsibility.

REFERENCES

• etectRx Announces U.S. FDA Clearance of Novel Ingestible Event Marker [news release]. Gainesville, FL; December 9, 2019: etectRx website. https://etectrx.com/etectrx-announces-u-s-fda-clearance-of-novel-ingestible-event-marker/ Accessed January 17, 2020.
• Breakthrough ID-Cap System from etectRx^TM Selected to Measure Adherence to HIV Treatment in New University of Colorado Study [news release]. Gainesville, FL; January 12, 2020: etectRx website. https://etectrx.com/breakthrough-id-cap-system-from-etectrx-selected-to-measure-adherence-to-hiv-treatment-in-new-university-of-colorado-study/ Accessed January 17, 2020.
• Farr C. Digital health start-up once worth $1.5 billion is racing to keep lights on as investors flee. CNBC website. https://www.cnbc.com/2019/12/08/proteus-digital-struggles-to-raise-cash-after-1point5-billion-valuation.html Published December 8, 2019. Accessed January 17, 2020.