Digital Pills
Smart Pills, also known as digital pills or ingestible sensors, are a growing technology in the medical field for the next generation of diagnostic tools. These devices allow physicians to collect measurements and images of internal structures within a patient’s gastrointestinal tract. There are also non-diagnostic smart pills that are designed to monitor when patients take their medication in an attempt to combat the ongoing issue of medication non-adherence. The use of smart pills also raises important ethical concerns about how they affect patients, physicians, and society.
Background
The idea of the digital pill comes as an answer to the growing problem of medication non-adherence [1]. This is the growing problem of patients failing to take their medication at the right time or at all. This can be serious, especially for chronic diseases such as hypertension and diabetes where an estimated 40-50% of patients are believed to be affected by medication nonadherence (3). Nonadherence likely contributes to 100,000 preventable deaths and $100 billion dollars in preventable medical expenses each year (3). Digital pills are essentially ingestible sensors that aim to resolve this issue by allowing patients, loved ones, and medical professionals to track medication consumption (4). In 2017, the FDA approved the first digital pill, Abilify MyCite, which was developed by Otsuka Pharmaceutical Co [2]. The actual drug itself is called Abilify (generic name aripiprazole) and it is used for the treatment of schizophrenia and bipolar disorder (2). The sensor, developed by Proteus Digital Health, is composed of a silicon chip with a logic circuit and the two metals magnesium and copper (2). When the pill comes into contact with solutions consisting of polar molecules (like gastric acid in the stomach) it dissolves leaving behind the silicon chip [3]__2____. When the chip interacts with the surrounding solution it becomes activated and is able to transmit a transient electrical signal (modulated current) to a wearable patch on the patient (2). The signal received by the patch consists of a single number that informs the patch what medication has been ingested (2). Through Bluetooth, the wearable patch can relay the information to mobile devices to a compatible app [4]__2____. This information, with the required patient consent, can be shared with the patient’s loved ones, caretakers, and/or physicians to make sure that the patient avoids medication non-adherence. This information can also be used by the patient’s physician to assess whether a new treatment plan needs to be implemented if the expected results are not seen.
Types of Smart Pills
Imaging Capsules
These smart pills are a type of diagnostic instrument that enables doctors to collect visual data about the structural integrity and condition of organ lining inside the different organs of the gastrointestinal (digestive) tract. A major advantage of imaging capsules is that they provide an alternative to traditional imaging techniques that use tube endoscopes which are quite invasive (5). Endoscopy instruments also tend to be large and rigid which limits access to many areas of the gastrointestinal tract and brings great discomfort to patients (5). Over the years, imaging capsules have made great progress with improved algorithms for detecting hemorrhage and lesions and enhanced video quality (5).
Current Products
WCE by Given Imaging Inc. (5)
PillCam SB by Given Imaging Inc. This is the first swallowable camera capsule released by Given Imaging inc. and it is used to analyze the small intestine (also called small bowel, this is where SB comes from) (5). Since the initial release in 2000, newer versions have been released with greater battery power and imaging resolution (5). The images are collected by the receiver and later examined by gastroenterologists (5).
PillCam ESO by Given Imaging Inc. This capsule is used to take images of the esophagus and there are two cameras, one at each end, to get more information in less time (5). The pill travels down the esophagus very quickly (10s of seconds) and consequently, the pill is designed to have a short battery life but a high frame rate (5).
PillCam COLON by Given Imaging Inc. A small capsule used to image the colon and these are mostly used as complements to the traditional colonoscopy procedure (5). Due to the larger size of the colon, the cameras on this capsule are equipped with wide-angle imaging (5).
Endo Capsule (Olympus Inc.)
OMOM capsule by Chongqing Jinshan Science and Technology
MiroCam capsule
Temperature Sensing Capsules
Temperature sensing smart pills are a diagnostic tool that can be used to make sure body temperature remains within the homeostatic range and they can also be used to measure heat stress in patients (5). There is a growing trend of the inclusion of temperature sensing capabilities in other pills that have a different primary function (5).
Current Products
CorTemp by VitalSense. The capsule consists of a thermistor-based temperature sensor and is usually used for core body temperature measurements (5).
pH Monitoring Capsules
pH monitoring capsules serve as a diagnostic measure that can help physicians track pH fluxes in patients. pH is an important characteristic that measures the level of acidity in a given environment. This characteristic becomes especially important when working with the gastrointestinal tract as different organs maintain different pHs. Imbalances in pH can lead to many diseases such as ______ and monitoring for these changes can be life-saving. These capsules are designed with a battery life of several days and this feature allows doctors to use pH capsules to assess the passage time of a patient’s gastrointestinal tract as a whole or of specific organs based on pH changes (5).
Current Products
Bravo pH monitoring system
Medication Monitoring Pills
The medication monitoring pills can be used by patients and doctors to make sure that the patients are taking their pills according to their prescription and that they are not skipping any of their medications. Medication non-adherence is a growing problem that is preventable and the monitoring pills provide a viable option (1).
Current Products
Abilify MyCite
Capsules in Development
Research into the field of smart pills continues to grow as new illnesses are discovered and new therapeutics are needed. Currently, research on gas sensing capsules, visible and infrared wavelength spectrometry capsules, Raman Spectroscopy, Confocal Microscopy and Optical Coherence Tomography, and Electrochemical sensing capsules is being done (5). Some of these pills are further in clinical trials with human patients, others are still in animal trials, and some are still just ideas (5).
Ethical Concerns
Patient-Related
Autonomy and Informed Consent
Typical medical procedures, from simple tasks such as measuring a patient’s blood pressure to more invasive tasks such as drawing blood all require informed consent from the patient. The addition of technology brings in an additional stipulation, the user agreement (6). These forms tend to be extensively long and written by lawyers to describe in detail how the software and hardware of the product can be used (6). This can lead to issues in informed consent as the patients may not always fully understand the user agreement. Traditional informed consent gives the patients the convenience of a face-to-face conversation with their doctor to address all their concerns and obtain a proper understanding of the situation. User agreements do not offer such services and many times patients do not fully realize what they are agreeing to due to comprehension difficulties of the form (6). User Agreement forms can also be updated at any time without notice and are non-negotiable which may infringe on patient autonomy (6). Many user agreement forms require the patients to allow the company to collect data so that they can continue to improve their product. If a patient is uncomfortable, their alternative is to find a completely new treatment, an option that may not be feasible for all patients. This can potentially put the patient in an uncomfortable situation where they feel as if they do not have complete control over their choices.
See Also
References
- ↑ impacX Team. (2021, May 10). Smart pills: The era of Edible Digital Pills has arrived! impacX. Retrieved January 28, 2022, from https://impacx.io/blog/smart-pills-what-are-these-edible-digital-pills/.
- ↑ impacX Team. (2021, May 10). Smart pills: The era of Edible Digital Pills has arrived! impacX. Retrieved January 28, 2022, from https://impacx.io/blog/smart-pills-what-are-these-edible-digital-pills/.
- ↑ impacX Team. (2021, May 10). Smart pills: The era of Edible Digital Pills has arrived! impacX. Retrieved January 28, 2022, from https://impacx.io/blog/smart-pills-what-are-these-edible-digital-pills/.
- ↑ impacX Team. (2021, May 10). Smart pills: The era of Edible Digital Pills has arrived! impacX. Retrieved January 28, 2022, from https://impacx.io/blog/smart-pills-what-are-these-edible-digital-pills/.
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