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.
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?
It’s a novel development, and simple enough to warrant some study, but I think I’m more interested in faster, smarter insulin.
The device is intriguing. So is the idea of smart insulin. But since the device is tangible and the development of the smart insulin still in the early stages, I would be satisfied with using the device until the insulin is available. I’ve never been very good with the whole “wait 20 minutes after bolussing to eat.” With the CGM I’m being advised to calibrate, wait 20, bolus, wait 20. Oops, mealtimes over with no time to eat. So I skip the latter and my blood sugar spikes, again.
Incorporating the device with the pump would probably be best.
Eek! Sounds good but 100 degrees? Is anyone else worried they might sweat the site off? I realize its only during a bolus, but I have enough trouble keeping my sites stuck for 3 days anyway (even with skin preps and tapes).
I can already hear my 4-year-old now: “Mom, it’s HOT. And it ITCHES. And it’s HOT! And I’m TOO LITTLE!” Those are his standard explanations for why there’s a problem with pretty much anything he doesn’t want to do, touch, or wear, and at least two of those are likely outcomes of this device.
It’s an interesting idea. However, I think it would be much simpler to just put a heated rice pack (or similar) over the site if you really need to knock down a high BG. Of course, that would be completely impractical anywhere but at home.
My meal schedule on Dr. Bernstein’s diet is somewhat flexible. So long as I wait 5 or more hours since my last meal, that is. I can skip a meal if I want to. Of course, I will have to eat sugar if I’m doing physical work and skip eating a meal.
The only inflexible part is timing. I need to eat exactly 30 minutes after
injecting my meal insulin. But that works well. I can prepare most meals in 20 to 30 minutes. If a meal takes longer to prepare, I just delay injecting insulin until half an hour before I plan to eat.
When I am away from home and only have half an hour to eat, then I
make sure I have a Bernstein-compliant meal packed and ready to eat.
The bottom line is half-hour insulin timing is a PITA, true. But I can easily work around it. I just need to use a 30 minute countdown timer in case I get distracted. Otherwise, I might go off the deep-end, bloodsugar-wise.