- Healthcare providers have long thought that the best way to measure a treatment’s effectiveness is from inside the body.
Now they’re getting that chance.
In a California hospital, patients diagnosed with hypertension will soon be taking their medications embedded with tiny, dissolvable sensors that will stream information to them and their doctors. In Illinois, meanwhile, an international team of scientists has developed a sensor that can be implanted in the brain to monitor temperature and pressure, then naturally dissolve.
Barton Health, a one-hospital, 110-bed health system in Lake Tahoe, is conducting what’s widely considered to be the first trial of ingestible sensors in the world. The hospital began enrolling patients last month in the pilot, in which it’s teaming with Proteus Digital Health, a Silicon Valley-based developer of the Proteus Discover ingestible sensor.
Dr. Clint Purvance, the hospital’s CEO and a practicing physician, says the sensor, the size of a grain of sand and embedded in a generic pill at a San Jose-based compounding pharmacy, is designed to measure the medication’s effectiveness the moment it enters the stomach. More importantly, it gives providers the best chance of knowing exactly when and how much of a medication is taken by the patient.
“Medication adherence is crucial in shaping clinical outcomes,” he says. “This allows both doctors and their patients to have the best data available to make decisions on a future course of action.”
Once activated, the sensor streams information – time taken, activity and heart rate – to a patch worn by the patient, then to the cloud. The data is available to the patient on his or her mobile device, and is shared with the patient’s physician. The data can also be accessed on a clinical dashboard by care teams, and aggregated for population health programs.
Purvance says this method is far more accurate than asking a patient whether he/she is following doctor’s orders on taking medications. “It’s a great tool for us to really understand what a patient is doing,” he says. And while measuring adherence, it also tracks how that medication affects the patient and treats the symptoms.
“There’s a lot of measurement of physiological data with this,” he says. “But more interesting to us is just how well we can measure medication compliance and adherence. … It allows (the patients) to have that data to make the best decisions on their own care.”
Barton Health is targeting 100 patients with hypertension in its initial trial, but some of those patients will have multiple chronic conditions, such as diabetes and high cholesterol. Purvance expects to expand the use of ingestibles in due time to other chronic conditions.
“For any chronic medical condition that’s out there, it certainly has applications,” he says, adding that “it wasn’t a hard sell” to convince either his clinical staff or patients to accept the idea of ingested sensors.
The concept of implanted sensors isn’t new – think pacemakers, defibrillators, implanted blood glucose monitors and electrodes implanted in the brains of patients with epilepsy or Parkinson’s. What is new is that sensors are now being created from “green” electronics, or materials that dissolve naturally inside the body, so that the sensors aren’t permanent or require upkeep.
Proteus launched its first ingestible sensor in 2012, targeting national statistics that indicate half of all patients don’t take their medications as prescribed, resulting in some $100 billion to $300 billion in avoidable healthcare costs in the US. Last July, the FDA expanded its Indication for Use statement to enable the sensor to be used in medication adherence measurement.
“We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings,” Dr. George Savage, the company’s co-founder and chief medical officer, said at the time.
Recently, an international team of researchers based at the University of Illinois at Urbana-Champaign created a miniaturized brain implant that dissolves naturally into the brain tissue. As described in an abstract in Nature, the sensors are smaller than a grain of rice and attached to a silicon chip that rests on the brain’s surface. A wireless patch on the head transmits data, such as intracranial pressure and temperature.