Here's some news that reminded me of The Jetsons, a Space Age cartoon I watched as a child. Late last month, the FDA approved a tiny ingestible sensor used to create "digital pills" that will help patients, their families, and healthcare providers to monitor medication adherence.
The microchip sensor, approved for use in Europe in 2010, is made by Proteus Digital Health (formerly Proteus Biomedical Inc.) in Redwood City, Calif., and is no bigger than a grain of sand. It can be placed inside oral tablets during manufacturing, or it can go inside a placebo tablet that is then co-encapsulated with oral medications. The sensor, which rests in the center of an excipient disk, is coated with minute amounts of copper salt on one side and magnesium on the other. After ingestion, contact between the pill and the patient's digestive fluids generates a small electric current that sends a unique signal from the sensor to a disposable patch worn on the patient's skin.
Data fed to a mobile app
The patch can then transmit information from the sensor to a special mobile phone app that patients, family members, caregivers, and healthcare providers can access. Patient data -- including the exact time the pill is taken and the patient's heart rate, body position, and temperature -- is sent via mobile phone to a secure server, where it can be integrated with patient data obtained from other wireless devices (such as blood pressure cuffs, glucometers, and weight scales).
In an October 2010 clinical study of the device published in the journal Wireless Health, researchers from Proteus Biomedical wrote, "These combined data streams allow therapeutic events to be viewed in the context of a person's physiology, thereby providing important links between treatment, behavior, wellness, and therapeutic response." By enabling patients to access and share their medication adherence data in conjunction with physiologic information, the sensor can "provide a platform for targeting feedback and providing tailored management for wellness promotion."
The hope is to use the system to improve treatment efficacy for patients with chronic diseases, since they may need to take medications for a long time. "We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe," George M. Savage, MD, cofounder and chief medical officer of Proteus Digital Health, said in a news release announcing the FDA approval. "We are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings."
In their 2010 report on the digital pill in Wireless Health, Kit Yee Au-Yeung, PhD, and coauthors concluded that it is safe, with no evidence of sensor-related toxicity, and that its use is technically feasible, based on preclinical studies (in rats) and three early clinical assessments in patients with tuberculosis (n = 30) or heart failure (n = 8), plus a control group of healthy individuals (n = 25) who took placebo tablets.
Following the human studies, which generated data from 3,277 sensor-ingestion events (2,788 in a clinical setting, with subjects directly observed by the investigators, and 489 in a non-clinical, at-home setting), Dr. Au-Yeung and her colleagues concluded that the digital pill system had very good sensitivity, specificity, and identification accuracy. Overall digital pill system sensitivity, compared with directly observed ingestion, was 97 percent, and it was not affected by the type of meal taken. Overall system specificity was 97.7 percent.
Dr. Au-Yeung and her colleagues also found the system "identified and differentiated up to 4 simultaneously ingested sensors with an identification accuracy of 100%." In a separate pilot study involving only heart-failure patients, the sensor system successfully isolated sensors associated with furosemide (used to treat hypertension and edema due to congestive failure) from sensors linked with a placebo.
The researchers wrote that additional studies of the digital pill are planned in organ transplant, schizophrenia, diabetes, and HIV/AIDS patients. Proteus has not disclosed any plans to study the system in cancer patients.
Dr. Eric Topol, professor of genomics at the Scripps Research Institute and author of The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare, said in the news release, "Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management."
What do you think? Could this system have applications for monitoring adherence to oral therapies for cancer?
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