For security supervisor Jesse Alberio, the pain from his diabetic neuropathy grew so bad he thought he might not be able to work any longer.
“It affected both of my feet,” says Alberio, 52, a type 2 diabetic for almost a decade. “I tried aspirin, and ibuprofen, and other pain killers, but nothing was working. The pain was intense. It was like my toes were constantly being crushed. I thought I’d have to retire from my job.”
Alberio is one of almost half of all type 1 and type 2 diabetics, who number almost 177 million worldwide and 30 million in the United States, suffering from some degree of painful diabetic neuropathy, which is damage to the peripheral nerves in the body as a result of prolonged hyperglycemia.
A visit to his podiatrist’s office, however, provided Alberio with an option other than being zonked out on pain medication and retiring early.
“My foot doctor wanted me to try this device,” Alberio says. “It was this thing that looked like it had electric shocks. I was skeptical.”
What Alberio was dubious about was a wearable device called Quell from a company called NeuroMetrix, Inc, designed to alleviate chronic pain,
According to NeuroMetrix, Quell is a wearable intensive nerve stimulation device that stimulates sensory nerves in the upper calf sending neural pulses to the brain. This triggers the release of endogenous opioids into the spine where pain signals are blocked in the body, which thereby delivers widespread pain relief. While it works along the same pathways as other pain-relieving, drug-based opioids, the dangerous side effects of such pain relief, such as addiction and artificial euphoria, are avoided because endogenous opioids (which are naturally occurring in the body) are targeted to only relieve pain.
The electronics of the device are housed in a sleeve much like a sport band, or blood pressure cuff, and worn on the upper calf.
“It’s pretty cool,” says Frank McGillin, Senior Vice President and General Manager for Consumer Health at NeuroMetrix. “What’s particularly exciting is that this is designed and cleared for use 24/7. You never have to take it off.”
By “cleared” McGillin is referring to the FDA’s 2014 approval for patients to use Quell as a class 2 medical device. The ruling means that, although Quell is available to consumers, it is not a prescription device. The $249 cost of Quell is not covered by most insurance carriers, according to McGillin. It is possible, in some cases, that the cost can be applied to a Flexible Spending Account, which is money an insurance holder sets aside before taxes that can be applied to nonprescription drugs and devices.
Additional costs associated with Quell include replaceable electrodes. Each electrode lasts about 100 hours. A one-month supply, consisting of two electrodes, costs $29.95, according to the company’s website.
By “designed” McGillin is referring to the four years of work that went into transforming relatively old technology so that Quell could be made available as a viable consumer product.
Quell is based on transcutaneous electrical nerve stimulation (TENS) technology, which has been in use since the 1970s as a diagnostic tool to measure nerve damage before patients became symptomatic. TENS, however, was only available in devices for use by medical professionals, according to McGillin.
“Our question was, ‘How do we bring this technology to more people suffering from pain?’” says McGillin, who previously worked at Phillips, bringing Sonicare to the market, and at Johnson & Johnson. “That was an important question to us because we wanted to help break the cycle of chronic pain that so many people suffer. That cycle, if left untreated, can cause significant health risks down the road.”
McGillin is quick to point out that Quell is not a cure for neuropathy, or for other painful conditions brought about by nerve damage. Rather, he says, it is a way to alleviate pain by using the body’s natural chemistry, instead of drugs. But, reducing that pain can have profound effects on a diabetic suffering from diabetic neuropathy.
“It’s simple,” McGillin says. “If people are in less pain they become more active and their overall health improves. They can get up and do stuff that they couldn’t do if they were in pain. They can go walking on a regular basis, for instance. That can help them control their weight, and blood pressure, and feel better.”
So far Quell has sold about 8,000 devices, McGillin says, adding that sales are on track for the company’s expectations.
Quell so far has exceeded at least one person’s expectations. Jesse Alberio became a convert to using Quell after he experimented to see what things would be like if he didn’t use it.
“It was working well,” he says. “But then I took it off for two weeks. The pain came back. Simple as that. That’s when I knew this thing really worked. It was time to put it back on, and I’ve had it on ever since.”