In preliminary study findings presented at the American College of Cardiology’s annual meeting, Proteus Digital Health reported that tracking medication adherence with its ingestible sensor improved blood pressure control in a group of hypertensive patients.

About 70 million people in the United States have hypertension and its estimated that only half have their blood pressure under control. There are a number of strategies being explored for getting a better handle on this condition, like the use of home blood pressure monitoring or engaging pharmacists to more actively manage medication titration.

But as C. Everett Koop famously said, drugs don’t work in people who don’t take them. Proteus has developed an ingestible sensor that we’ve covered in the past that tracks medication adherence in the most direct way possible. Basically, a medication, say lisinopril, is combined with a tiny ingestible sensor that sends a signal to a patch worn on the skin when it dissolves in the stomach after someone has taken their medicine. That gives caregivers, whether a doctor or a patient’s family member, a way to objectively track medication adherence. Any number of systems to then improve adherence could be built on top of that.

In this study, 96 patients with a mean age of 58 and evenly split between men and women who had uncontrolled hypertension despite at least two anti-hypertensives were enrolled. Patients were randomized to usual care or Proteus Discover, a medication adherence system built around their ingestible sensor. At four weeks, 85% of patients in the intervention group had reached their BP goal vs. 33% in the usual care group; they also had a greater reduction in SBP (-23 mm Hg +/- 2 vs. -14 mm Hg +/-4).

These are preliminary findings and full results are expected to published later this year, hopefully in a peer-reviewed journal. It will be interesting to see in particular what sort of ancillary support came with Proteus Discover. I’d interpret the findings very differently based on how they did the study, particularly generalizability and scalability. A protocol where a research nurse was calling patients daily would be very different than a protocol where a missed dose triggered an automated text message. A cost analysis would also be critical to understanding how scalable this platform will ultimately be.

Its worth noting that Proteus is also engaged in research testing their platform in a number of other conditions including tuberculosis and psychiatric diseases. A quick search of the clinicaltrials.gov database revealed several studies, some at academic centers and others purely by industry:

Tuberculosis: Study in San Diego comparing directly observed therapy to wirelessly observed therapy by combining TB drugs with Proteus’ sensor system.

LVADs: Testing the Proteus sensor system in patients with left ventricular assist devices (LVADs) for safety.

Bipolar disorder or schizophrenia: Tracking medication adherence in patients with these conditions by combining medications with Proteus’ sensor system.

Reference: Press Release