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| Withings Blood Pressure Monitor--Courtesy of Withings |
At the annual AdvaMed convention, Dr. Eric Topol of the Scripps Research Institute in La Jolla, CA, laid out his vision of a healthcare future dominated by mobile patient monitors and real-time sensors during a luncheon speech. He left some wondering why the technologies were not already the standard of care, while others thought the vision was a bit unrealistic and impractical. Alas, a 160-patient, 6-month randomized controlled trial by Topol and others found little evidence of clinical or economic benefit as a result of interventions with mobile devices.
"It was a bit disappointing, but remember, this was the first multisensor trial that's ever been reported, so in that respect it was a pioneering effort," Topol, the director of the Scripps Translational Science Institute told MobiHealthNews. "And you know, it was very difficult because we had these three different sensors, glucose, blood pressure, and heart rhythm, and a lot of patients had all three problems or two of them, and had to have a dashboard created. There are a lot of logistical challenges there."
The mobile devices tested were Withings' Blood Pressure Monitor among hypertension patients, Sanofi's ($SNY) iBGStar Blood Glucose Meter among patients with diabetes, and Fierce 15 company AliveCor's Mobile ECG for monitoring atrial fibrillation among patients with arrhythmias.
All patients in the treatment group received an iPhone with linked tracking applications. And Qualcomm Life's HealthyCircles care coordination and management platform to share the data with caretakers and physicians.
Those in the control group received a standard disease management program.
After looking at resource utilization in health insurance claims data, the team "found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes," according to the paper abstract.
For example, the average number of office visits, emergency room visits and inpatient stays did not differ significantly between the two groups, nor did the value of health insurance claims filed ($5,596 for the control group and $6,026 for the treatment group).
Moreover, direct measures of clinical outcomes did not differ either. The paper says that both the control and treatment group had similar levels of systolic and diastolic blood pressure, and hemoglobin A1c levels.
There was one (small) bright spot: "Among secondary outcomes there was some evidence of improvement in health self-management which was characterized by a decrease in the propensity to view health status as due to chance factors in the intervention group."
As Topol pointed out, the trial does not settle the debate due to the novelty of the issues being studied and the devices being used, but it is disappointing.
"We learned a lot, but the fact that it wasn't a positive trial, with respect to reducing economic burden is probably not so surprising because we only followed the people for 6 months, and many would project that you need much more follow-up and a much larger sample size to be able to show the burden," Topol told MobiHealthNews. "The good part is we didn't add any burden economically. A lot of people thought, if people have access to their data they're going to end up tapping more into medical resources. Well, we certainly didn't see that. So that was encouraging, but obviously we would have liked to reduce the need for emergency rooms and office visits and hospitalizations. That could still be out there, but this is just the beginning of studying that question."
- read the study in open access publication PeerJ
- here's more from MobiHealthNews
Special Report: FierceMedicalDevices' 2014 Fierce 15 - AliveCor