Pens are a device that we kind of don't think about or talk about. Most of the conversation about delivery systems is left to talking about pump technology. However, pens are a basic device delivery system that I feel has missed the mark for people with diabetes.
Most people with type 1 view the pump as the ultimate management device for diabetes, and I don't disagree. But, for people with type 2 and a percentage of people with type 1, pens have long been the preferred management option over syringe and vial.
Statistics show that 12% of the US diabetes population uses insulin-only and 14% use orals and insulin. What does this mean in terms of numbers of injectable insulin users? Roughly, 7 million people in the US.
Globally, insulin syringes and pens dominate the market, which has to do with two major factors: the majority of injected insulin is basal insulin and national healthcare infrastructures that have to pay for the basic care of people living with diabetes. For many of the type 1 population in the EU, the expense of a pump has to be justified in order to have it covered by national healthcare system, so MDI is the standard practice of care. Something is lacking in pen technology, though.
If pens and syringes hold the market share, then why haven't manufacturers offered pens with more dosing flexibility? Need a half unit in US? Great You have two insulin companies offering pens with half-unit dosing, and only for rapid acting insulin. Novo Nordisk's Echo Pen and Lilly's Humapen Luxura HD. Sanofi has a new junior pen that will allow for half unit dosing for either Lantus or Apidra. I'm thrilled that the pen can be used with both basal insulin and rapid acting insulin, but I'm lost as to why it's only available in Canada and EU. And, why I'm considered a junior for needing a half unit or less of insulin? (Full disclosure: I am a consultant for Sanofi US Diabetes).
My issue is not only do we have limited access in the US, but simply that the pen technology has not kept up with the updated diabetes management needs. Tighter control means that insulin might need to be in smaller increments and current devices lack the flexibility to dose for what you need.
Early last year, I stumbled onto a website for a new pen technology that has me and Close Concerns excited. Diamesco is a Korea-based company that developed Pendiq, a digital insulin pen, and it is catching fire in the EU. Pendiq, pronounced Pen-DEEK, is motor driven and can deliver 5 units per second. Diamesco has been manufacturing pumps and needles for the EU and now it has added a "smart pen" to it's list of products.
Bjorn Moldenhauer, Pendiq distribution partner in the EU, explained to me some of the nuances of Pendiq:
"It is true that most analog insulin pens do not offer the technical advantage of small or tiny doses. But the great success here in Europe has shown that there is a very high demand for this. Think about toddlers who require the finest dosages, something that only the digital insulin pen Pendiq can offer. Dosages with a minimum dose of 2.0 units and in increments of 0.1Units (!) can be made.
The Pendiq insulin pen is operated with common 3ml insulin cartridges commercially available in Europe, but currently only the cartridges of the manufacturers Sanofi-Aventis, Lilly and Berlin-Chemie can be used, which has its reason in the programming of the pen. Of course basal insulin can be used. The insulin cartridges of the brand Novo Nordisk cannot be used because they do not fit into the Pendiq insulin due to the cartridge configuration."
Pendiq has a maximum dose of 60 units. To inject, a person would press the ACT button at the base of the pen and a small light flashes red, while the screen displays a countdown. Once the insulin is delivered, the light changes to green and the display reads "end." The pen is rechargeable and the current battery life lasts up to 10 days, based on 3-4 injections per day. The recharge is done through a USB cable, and has an alarm that tells when the battery is running low. In case of emergencies, it can be switched to a manual mode. The pen comes in four colors: orange, green black and grey.
The Pendiq pen comes with a data downloading (USB cord) and stores 195 doses worth of memory, and it can be preprogrammed for boluses so that with one push of a button, the pen will know how much insulin to give based on the time of day.
The cost of Pendiq runs $169.00 euros with 19% VAT, which may seem like a lot, but compared to the cost pumps, or the lack of dosing flexibility in the current pen market, this doesn't seem out of range for all that it does.
So, when is it coming to the US? Currently, there is no plan of introducing it here, but hope springs eternal for this blogger.