Calibra Medical’s new insulin “patch pen,” brand-named Finesse, has been approved by the FDA and performed extremely well in recent patient studies. The product could be a huge hit — if the company can secure the financial backing it needs to get production off the ground, according to the physician leading their research charge.
So let’s start at the beginning here: What the heck is a “patch pen,” anyway? That’s what I wan
ted to know. Most people would refer to Finesse as a patch pump, being the more common term for an insulin delivery device worn on the skin like a bandage. This one is extremely small and flat (2″ × 1″ × 0.25″), and contains a 200-unit insulin reservoir.
It delivers bolus doses only, which can be accomplished right through your clothing by squeezing together the 2 buttons on its sides. It’s targeted at both type 1 and type 2 patients currently on injections, as a much easier and more discrete way to deliver mealtime, snack, and correction boluses. It’s been FDA approved for up to 3 days’ use with Novolog rapid-acting insulin. (Patients still need to inject their long-acting insulin.) For more details on the design, see Bernard’s review here.
“Pumps are coming under great FDA scrutiny right now. I guess they’re calling it a patch pen because it delivers bolus doses only, replacing the dosing patients would normally do with an insulin pen,” says Dr. Nancy Bohannon, director of clinical research at the Cardiovascular Risk Reduction Program, St. Luke’s Hospital, here in San Francisco, CA, who led the recent feasibility clinical trials for Finesse.
Here’s what else she had to say:
“In my part of the study, I had 10 patients, mostly type 1s. The company wanted a two-to-one ratio on type 1s to type 2s, because they wanted to get approval for use with type 1 diabetes.”
“It’s much, much smaller than the OmniPod or Valeritas’ V-Go or anything else. That’s why a type 1 would want it over MDI, but not over a full-featured pump. If someone doesn’t want to wear a full pump, even the OmniPod, then this a lot more convenient than a pen or syringe and vial, for sure.”
“Patients absolutely loved it! They were very upset that they couldn’t stay on it. One guy even volunteered to be the poster boy for the product and write a marketing jingle about it.”
“I want it for my Symlin patients — they don’t like having to fiddle with the pen. But that would require additional studies to show that it’s bio-compatible, that it’s OK for Symlin to be sitting in the pump for 3 days. (That doesn’t mean people won’t stick Symlin in it).”
I also spoke about Finesse with Elaine Massaro, a leading CDE from Chicago who recently won the 2010 Diabetes Educator of the Year award. She also just completed research with 10 patients on Finesse: half type 1s and half type 2s. She explained that dosing is set differently for each group: 1 unit per squeeze of the buttons for type 1s, and 2 units per squeeze for type 2s.
“It’s really, really easy to use, and you don’t even have to lift up your shirt to do it. Even if you’re thin with a tight shirt, you can’t see it. And for insulin insertion, there’s no cartridge or anything. You just stick a needle (a regular 2cc or 3cc syringe) into the port and fill it.”
“Our group improved by far! One man was at was almost at an A1C of 10, and went down to 6.8 in the study. Of course, the participants also got a lot of intensive management and teaching on diabetes care, but I think the ease of use was a great motivator.”
“The main thing people requested in feedback had to do with the adhesive. They found it wasn’t big enough and not sticky enough to stay put. Still, they wanted to buy it right away. I think it’s very useful and valuable for patients.”
For my part, I’d normally complain about the hospital-grade beige plastic look, but I think in this case they were going for skin color as “camouflage”…?
Phase 2 trials are slated to start in February 2011. This round will be mainly for “marketing purposes,” Dr. Bohannon tells me, meaning they’ll be working out the kinks with adhesives, etc.
Dr. Bohannon sums up her view: “I see it just taking off! People love it. It’s so small you can wear it under a bikini… This company is ready for launch. The only thing that’s holding them up is they need more VC money to build the factory. Right now they’re making them by hand.”
Investors: If you are reading this, take a closer look at the Finesse “patch pen” – a potentially confusing name for what seems to be a very simple and highly practical diabetes device.
Thank goodness someone finally realized beige (or brown) was the way to go! The original dexcom system had a white/clear sensor with a black transmitter. Perfect for showing through a lot of clothing, especially blouses. The 7+ system has a white transmitter, much better, but still shows off when you’ve got a bathing suit on. As does the omnipod.
I’ve liked this product for a while now. It’s simple, effective and would take the burden off 8 needle jabs a day. In my case I need a minimum of half unit increments and ideally 0.25 unit increments (which is what I use with syringes). I think the current implementation uses 1 unit increments?
Seems like a good tool for lantus basal and syringe free bolus.
It does look like a good product, but it does have some drawbacks. I agree with David that a lack of fractional units is a minus, but in the Bernard Farrell review it says they are planning a pediatric version that doses 0.5u. The downside to that is not all people who need half unit dosing are pediatric patients who require small doses so even doses above about 2u will be frustrating to administer and get more frustrating the higher they go. I can’t imagine having to click a button 11 times to get a 5.5u dose for instance.
It also seems very odd that there isn’t some sort of window to see how much insulin you have left. That would be a no brainer from the get go I would have though.
Lastly, I don’t know if the cost would be worth the payoff. The price of insulin wouldn’t change so it would really be paying more for slightly more convenience. I don’t know if I would want to pay more than $10-20 a month for what it offers.
I do think it’s a great idea and would definitely be something useful, but it just seems to have too many drawbacks right now and addressing those drawbacks properly would turn it into a sort of poor mans pump or too expensive pen replacement.
I am concernrd about the size of the needle. Its 27G which I think its quite thick. Apart from that it looks nice and we would give it a try if it was reasonably priced.
The pediatric version sounds right for me. However, it looks like the cost vs benefit is poor in my case with my insurance. Unlike pumping, the patch pen would not eliminate my copay for syringes (or basal insulin), so I would still pay all my usual copays plus a new one to cover this patch pen which I estimate would cost me a minimum of $360 per year. Well, $360 is over half what it would cost me to use a (tubed) pump! This cost vs benefit is okay but not great. Am I overlooking something here?
Calibra might want to consider bumping their price up a bit and throwing in 4 syringes per patch pen, thus eliminating the need for patients to pay an extra copay for syringes. 4 syringes=1 syringe per day to inject basal insulin plus 1 to fill the patch pen.
What a great advancement. I hope they can find the backing they need. This would be a huge benefit to the diabetes community.
I was just musing … Wouldn’t it be great if I could have the convenience of pumping (when I wanted)for boluses and the freedom from being attached 24/7. I hope it becomes a reality (and in user friendly .5 unit doses). Are you listening VCs? We’re waiting to spend money.
Size is always going to be a consideration in advancements like this. I think any move towards making administration easier and convenient will always be welcomed.
I always worry when someone says all we need is money to scale up to manufacture. Most researchers have no clue what a big deal relatively simple concepts can be to optomize in a cost effective manner. The idea that a high-quality handmade device can be easily scaled up to manufacture the quantities needed to actually make a profit without blowing up due to failed QC, poor training, profit-greedy suppliers, etc is one of the great kanards of our time. If additionally there are pricing considerations which either compress the margins or shrink the market as mentioned by some of the posters it may not matter how technically good the device actually is.
Thats Crazy, My mother and i were talking about this earlier this week. My mom was diagnosed with diabetes about 2 years ago. Although it hasn’t taken over her life she is determined to keep it under control. I emailed her this link. She loves to read up on it alot. I guess the old say still sticks and probably always will. Information is Key.
They definitely need to make it deliver 1/2 units, for insulin-sensitive adults. I am one!
[...] full article can be read here but for those of you that don’t have time to read it (it’s short!) here is the [...]
our daughter was dignos 2 years in dec can we be in a trial on the insulin pen can you please let us know how we can get involed in the trail
[...] who have used it in research has been very positive – as detailed by this post last summer on DiabetesMine.com. At this point, Calibra Medical is working to reduce the costs of manufacturing the device [...]
dear sir,
My daughter 8 year old newly diagnosis with diabetes type 1recently.
I am from new delhi (India). Please let me know about this product.
Regards
dinesh agarwal
Many years ago my brother wore something that, at the time, was called a “poor man’s pump.” It was a syringe like thing, if memory serves me correctly, that you kept up against your body. He used it along with that God-awful long-acting insulin, NPH, that we both took. Anyway, this looks like an ultra-modern version of the “poor man’s pump!”
We have been reading about the patch for over a year now. My 17 year old son with Type 1 was very excited about starting to use this, but it is still not on the market. Please let us know when this will occur. We are so optimistic about this new product!
Thanks….
Well, I’m hoping for it to Replace Our , So called, Long Lasting Insulin.the Lantus and Levemire with just suing Novalog on a Hourly basis..
The LLI’s don;t work as nearly as well as Using NLog , but you have to take it every Hour ..Get it set up to Deleiver it every Hour Like the Pump does and you have something.
Vs having to spend $10,000 for a Pump every 3-5 yrs..!
Many thanks for sharing these kinds of wonderful articles. In addition, the optimal travel plus medical insurance plan can often eliminate those issues that come with journeying abroad. Your medical emergency can soon become extremely expensive and that’s sure to quickly put a financial load on the family’s finances. Setting up in place the perfect travel insurance bundle prior to leaving is worth the time and effort. Thanks
i have a doughter 4 years old was daibatic recently from 1 month , i need to know how can i get this patch as she takes 3 units lantos per day , need your help
Well it’s a Start, but I can tell you from personal Experience
That so Call Long Lasting Insulins of Lantus and Levemire?
Don’t work as well as they will tell you.. Many of us have to take it 2 and 3x daily.. and even then..
It’s Been a Big Disappointment and A Very Expensive one at that..
They can make a Patch to deliver Morphine over a 12 and 24 hrs , why not the same for Novalog..?
Or Are the Insulin Pump Co.’s Lobbying against that too?
Getting how much per Pump Now? $7,000?
What a Racket..