Last month we addressed the under-discussed issue of lipohypertrophy. Lori Berard, chair of the Canadian Forum for Injection Techniques, helped ASweetLife understand the nature and scope of the issue, which is almost entirely caused by poor injection site rotation.
You may already be aware that if you inject insulin into the same spots repeatedly, you’ll inevitably develop lumps of unhealthy fat under the skin. This is called lipohypertrophy, and it can present serious challenges for blood sugar management. Insulin that’s injected into those unfortunate lumps is absorbed very unpredictably, which results in more frequent hypos, rollercoastering blood sugars, increased insulin needs, and rising A1C. Berard told us that the problem is far more wide-spread than even most diabetes professionals are aware of, and it may well explain much of the frustrating unpredictability that often defines diabetes management.
In one sense, it’s a simple problem. It shouldn’t be complicated or difficult to teach proper injection rotation, which can almost entirely prevent lipohypertrophy. But actually getting the message out is easier said than done: it would take a tremendous effort and a great deal of time to propagate new teaching techniques across such a wide network of professionals. And patients with diabetes are already overburdened with a million other things to think about.
A Montreal start-up named MontMéd thinks it has a solution. Their new product, SiteSmart, aims to give insulin pen users a simple reminder to rotate their injection sites. How does it work? Color-coded insulin pen needles.
The insulin pen needles we use today are generic and featureless. SiteSmart instead offers a box of insulin pen needles in four distinctive colors. The idea is that when you happen to pull a green needle from the box, you know to inject in one area; when you pull a blue needle, you know to inject in another.
When I spoke to Amir Farzam, the MontMéd CEO, he repeatedly emphasized SiteSmart’s ease of use: “It doesn’t need any tracking, any logging, no need to remember where you injected last time. It’s as simple as that.”
To help the beginner determine which body part each color corresponds to, SiteSmart comes with a body map, a system of colored stickers, and an optional smartphone app. But Farzam expects that patients will internalize the new associations quickly, and will soon be properly rotating their injections on autopilot. The colored needle alone is a reminder to change injection sites, a daily reinforcement of the principle of site rotation.
Farzam is extremely sensitive to the relentless stress that comes with diabetes, and explained that he did not want to pursue any projects that might make daily glucose management any more difficult: “There are already so many things for people with diabetes to think about. Any solution that adds to that list is not a good solution.” He has a kind of entrepreneurial mission statement that he shared with me early in our talk: “I want to develop simple innovations that bring in clinical value while reducing cognitive burden.”
SiteSmart intends to take a mere technical tool, one we already use every day, and change it into a teaching tool for better glucose management. As Farzam asked out loud, “Can a needle be more than just an insulin delivery device?” And by using bright colors and harnessing simple associations, the company hopes to make its lessons as natural and easy as possible.
MontMéd is currently looking for a larger business to partner with in order to bring the product fully to market. For now it is approved for sale in Canada, a first step that allowed the company to run a clinical trial in which boxes of SiteSmart pen tips were distributed by pharmacies to customers, without any special explanation or training. The results from the trial were positive – users indeed reported significantly improved site rotation– showing that the product gets results even when the SiteSmart system hasn’t been introduced or taught by an expert. The packaging and coloring alone, apparently, was enough to get the message across.
In a world where businesses will happily spend hundreds of millions and even billions of dollars developing new drugs and technology for diabetes management, it is rare to identify what may be such an effective technique that can also be implemented so inexpensively. Better injection site rotation may be the low-hanging fruit of the diabetes management world, as MontMéd estimates that the A1C reductions associated with improved site rotation are on a par with those associated with expensive technologies (insulin pump, CGM) and pharmaceuticals.
The added cost of SiteSmart’s innovations are almost nonexistent – new packaging and a little dyed plastic – but the benefits are potentially significant. Patients and insurers alike would stand to save money on both ends if better injection technique resulted in less insulin used in the short-term, and better clinical outcomes in the long term.