Have you ever sat in a hot tub for too long and noticed your blood sugar starting to take a dive? When the skin heats up, blood vessels expand and allow for greater circulation, magnifying the impact of insulin and pushing glucose levels down — a fortunate effect that Israeli-based company InsuLine wants to duplicate in their new insulin delivery aid products, called the InsuPatch and InsuPad.
InsuLine, which we first reported on following a JDRF Research Summit last Spring, recently announced positive results from a small clinical study on efficacy and safety with their InsuPatch, reporting that insulin action increased on average by 30% in 51 patients in the first hour. This means that, on average, after the first hour, 30% more insulin was working in a person wearing the InsuPatch compared to someone who injected their insulin normally. The FDA trial protocol required at least a 10% improvement, so 30% is definitely impressive and could mean a quick approval. InsuLine is now in the midst of their second clinical trial with 100 patients, expected to be complete this April.
So what exactly are these products?
The InsuPatch is designed for pumpers, and works just like a traditional pump set, except that it includes a heating element that warms the skin around the infusion site to 38-39° Celcius (circa 100° Fahrenheit) to aid faster and more efficient absorption. It's made for 3 days of continuous use, and connects to your insulin pump with an adapter.
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But people on injections don't have to worry about being left out! The InsuPad is a disposable pad with the same heating functionality, made for one-day use alongside injections.
Both products use heat to increase the speed of blood flow, which in turn increases absorption of insulin because it moves more quickly through the system. The heat is activated as soon as the insulin is injected, so happily users should see an increase in absorption speed that does away with the 20+ minute lead-time on food. And honestly, how many people eat on a predictable, fixed schedule anymore?
Is InsuLine's technology the key we need to speed up our sluggish insulin? There are still some lingering questions: how comfortable is heating the skin, how durable is the product, and how consistent is the increase in action? Will it work faster for smaller doses? The company rep we reached out to was tight-lipped on providing any info not already published, so we're still awaiting answers. With the conclusion of the second trial in April, we should be hearing even more about this new technology in the coming months.
We're intrigued by this technology, but very cautiously optimistic. As Kelly Close, diaTribe editor and a veteran type 1 PWD, explains, "InsuPatch just introduces one more thing to deal with and depend on, and we don't really know how safe/durable the product is yet."
Last Summer, CEO Ron Nagar speculated that the company might receive FDA approval in 2012, though you never know with FDA predictions. And there's also no word on how much these things might cost or how one might get the patch, since financial information is usually never clarified until after FDA approval is received.
Kelly speculates the company's best option might be to sell its technology to an established pump company as a standard option for infusion sets, adding, "It's hard for me to imagine many people shopping for the patch on their own."
This is the second stand-alone infusion product touting special capabilities that we've seen in the last year, and it's unclear how successful either will be. The other is the new Spring infusion set by a fellow Israeli-company.
So Dear Readers, what do you think? Does a special heating element for your infusion site sound like something you'd be willing to try? Or are you just holding out for smarter, faster insulin?