Did you know that people with diabetes who use insulin face the risk of adverse reactions when they take injections in the same spots over time? A novel product aims to make it effortless to rotate insulin injection sites and avoid complications.
Insulin Injection Site Rotation Is Important
When patients repeatedly inject into the same place, lipohypertrophy, the abnormal growth of fat tissue, can occur. This can hinder effective insulin absorption and lead to frequent inconsistencies in insulin dosing. Often, this can result in unpredictable blood sugar readings and can contribute to suboptimal diabetes control.
The best way to avoid these complications is to prevent them in the first place, and consistent site rotation is the best way to do so. However, it appears that a large percentage of patients struggle with this.
A recent international survey study of over 13,000 individuals, revealed that approximately 30% of insulin-using patients report experiencing lipohypertrophy. Another study examined over 400 patients and reported a much higher prevalence (nearly 65%). These study authors also noted that,
“There was a strong relationship between the presence of LH [lipohypertrophy] and non-rotation of sites, with correct rotation technique having the strongest protective value against LH. Of the patients who correctly rotated sites, only 5% had LH while, of the patients with LH, 98% either did not rotate sites or rotated incorrectly. Also, 39.1% of patients with LH had unexplained hypoglycaemia and 49.1% had glycaemic variability compared with only 5.9% and 6.5%, respectively, in those without LH.”
So, why is the prevalence of lipohypertrophy so high, when the preventative solution is seemingly so simple, and what can be done to improve on this common issue?
A Simple Solution to Improve Site Rotation?
Amir Farzam and Martin LaFontaine of Montmed, are passionate about improving these outcomes. They believe that appropriate site rotation is likely lacking due largely to:
- Not enough patient education about site rotation upon starting treatment
- Overload of new information presented to patients at diagnosis and/or initiation of insulin therapy
To overcome these issues, they have developed what they believe to be a very simple and effective solution to help improve insulin injection site rotation among patients in the real world.
What Is SiteSmart?
Montmed’s product, SiteSmart, builds on the existing and widely used product, insulin pen needles, and implements a four-color coding system to help users associate a particular color with a particular injection location.
A box of SiteSmart pen needles contains equal amounts of differently colored needles: green, purple, blue, and yellow. A diagram of optimal injection site locations appears on the side of the box and small colored stickers are included to encourage users to create their own injection rotation plan.
Studies Show Positive Improvements in Site Rotation
Recently, the company conducted a study to evaluate the efficacy of the product. Over 200 patients with type 1 and type 2 diabetes participated in the study. Excitingly, the study results revealed significant improvements in overall injection site rotation among SiteSmart users as compared to the control group (“a 134.7% increase in the likelihood to improve site rotation over conventional pen needle”). This included the use of more sites in total, the use of new sites, as well as the use of larger areas for injection.
Lori Berard, RN, CDE, Chair of the Forum for Injection Techniques Canada and principal investigator on the trial, had this to say about the outcomes in the recent press release:
“These data are very exciting in that they demonstrate that a simple, yet innovative, intervention like SiteSmart can help insulin users easily learn and adhere to a healthy injection site rotation regimen which should, in turn, reduce the risk of lipohypertrophy and the associated impact on glucose control and insulin use. I believe this is an easily-implemented intervention that doesn’t add any cost to the healthcare system, and that has the potential to deliver important clinical and health-care outcomes.”
Montmed CEO and President, Amir Farzam, added,
“These data support our belief that SiteSmart has the potential to transform the utility of an insulin pen needle from a simple delivery device, to a clinically valuable tool.”
Currently, SiteSmart is a patent-pending product that has already been approved for use in Canada but has not yet received FDA approval. Montmed looks forward to patenting the product and getting it through the FDA approval process for eventual distribution in the US. They are currently exploring opportunities for collaboration with existing manufacturers to help make their product available to as many patients as possible.
Improving insulin injection site rotation can help prevent the common complication of lipohypertrophy and potentially support better glycemic control due to more consistent and predictable insulin absorption in healthy tissue. Montmed’s SiteSmart aims to improve optimal site-rotation habits for patients with diabetes by helping to instill color-based associations between pen needles and injection sites, which will hopefully transform into lasting habits that improve injection practices.
What do you think about this product? Please share your thoughts in the comments and also tell us, what helps you to remember to rotate your injection sites more effectively?
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Read more about diabetes management, insulin, Intensive management, lipohypertrophy, U.S. Food & Drug Administration (FDA).