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 wanted 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" Ã— 1" Ã— 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:
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"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."
"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.