In the rapidly expanding universe of the Internet of Things, smart medical devices stand out by improving the quality and length of life, as well as efficiency of treatment. Chronic diseases like heart failure, diabetes and hypertension, which affect hundreds of millions of people worldwide, are logical targets for smart-device innovators.
Monitoring heart failure patients
Late last month the FDA approved the first permanently implantable wireless sensor designed to enable remote monitoring of a patient’s pulmonary artery (PA) pressure. The device can be implanted in patients with heart failure, a condition that affects about 5.8 million people in the United States, and more than 14 million people in Europe.
Heart failure, the final stage of heart disease, is a progressive weakening of the heart muscle that leaves it unable to pump enough blood to meet the demands of the body. In the U.S. and Europe, heart failure accounts for about 4.6 million hospitalizations annually. Each hospitalization requires invasive tests and creates a lot of stress for patients and their families.
The newly approved CardioMEMS HF System, developed by Atlanta-based medical device company CardioMEMS, is designed to reduce hospitalizations among patients with moderate heart failure by enabling physicians to identify problems and modify treatment before patients end up in the ER. The wireless sensor, implanted in the pulmonary artery, uses radio-frequency energy to transmit PA pressure measurements to an external electronics unit. That device then forwards the data to the patient’s medical team.
In the clinical study used for drug approval, 550 patients had the device implanted and were randomly assigned to one of two groups: patients whose doctors had access to PA pressure data or patients whose doctors did not.
After six months, the device was shown to be safe and there were 28 percent fewer hospitalizations for heart failure in the treatment group than in the control group. Over the full duration of the study (15 months), there were 37 percent fewer hospitalizations in the treatment group. Those patients also reported a better quality of life, based on a Minnesota Living with Heart Failure Questionnaire.
Making life easier for people with T1D
About 18 million people worldwide have type 1 diabetes (T1D), in which the body stops producing insulin. Patients must check their blood-glucose levels many times a day, and plan carefully to balance insulin doses with eating, activity, sleeping and other variables, such as medications, stress, and illness.
Many vendors are making devices for patients with T1D that incorporate various degrees of “smart”. Medtronic’s MiniMed 530G system, the most technologically advanced diabetes-management system available, integrates an insulin pump, glucose sensor (CGM), and glucose meter, which all communicate wirelessly. But all this machinary still requires some manual input from the patient.
The next step, already being tested, is an artificial pancreas: technology that constantly monitors blood-glucose levels and automatically provides the right amount of insulin exactly when needed. Such closed-loop systems include an algorithm that uses information from the patient’s CGM to determine whether the body’s glucose needs adjusting, then tells the insulin pump to give more or less insulin accordingly.
Recently, 16 British children with T1D ages 12 to 18 were given artificial pancreas technology and sent home for three weeks to use it on their own, away from the immediate management of the University of Cambridge researchers who coordinated the study. The results were promising. Researches concluded that unsupervised home use of this technology in adolescents is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia.
Ingestable sensor knows if you’ve taken your medication
A growing number of people are living with chronic diseases that can require long-term use of oral medications. According to the World Health Organization (WHO), approximately 50 percent of patients with chronic illness don’t take their medications as prescribed. This leads to increased death, and is estimated to cost approximately $100 billion per year.
Proteus Digital Health, a technology company based in Redwood City, California, has developed an ingestible sensor that it hopes will increase the effectiveness of existing medications by helping to ensure they’re taken as prescribed.
The sensor, made from dietary minerals (copper and magnesium), is the size of a grain of sand. The FDA and its European counterpart have approved the sensor encased in an inactive pill. The first wave of sensor-paired medications will rely on the inactive pill being taken at the same time as the patient’s medication. In the near future, Proteus hopes to have its sensors included in a single capsule along with common medications.
The sensor is part of Helius, a “digital health feedback system” developed by Proteus that has three components. The second component is a small disposable patch worn on the body. After a patient swallows the sensor, it’s activated by stomach fluids, which complete the power source and generate an electrical charge. The sensor signals a unique identifying number that is detected by the patch, which records that number and the time the pill was taken.
The patch also records heart rate, temperature, and activity and rest patterns, then transmits all the information to the patient’s mobile device, tablet or computer via Bluetooth. From there the information can be sent to a secure website where an application (the third component of the Helius system) enables the patient, his or her physician, and designated family members to view the data and confirm that a given dose of medication was taken. Doctors can also use the information gathered by the patch to better understand how patients are responding to their treatments.
According to analyst firm Berg Insight, by 2017 there will be 9.4 million patients worldwide being remotely monitored using dedicated medical devices with integrated connectivity. Juniper Research, another analyst firm, predicts that by 2018 all that connectivity will save the world’s healthcare systems up to $36 billion by reducing both outpatient visits and time in hospital. Smart, connected medical devices are key to making medical systems proactive instead of reactive, a change that will not only to save money, but perhaps extend the life of patients and improve their quality of life.