Anyone who’s worn a diabetes device stuck to their body knows that some type of skin issues with the adhesives are pretty much inevitable. Typical scenarios include:

The struggle is real for people with diabetes (PWDs).

While many life hacks exist as a way around these issues, it doesn’t eliminate the challenges — especially for those who develop a skin reaction to a particular ingredient in the adhesive paired with their chosen diabetes device, like latex for example. Heck, people have been suffering from allergies to simple band-aids and medical tape for as long as they’ve been around, so this is all very common.

But it’s a real concern for PWDs, because it can sometimes translate into not being able to use an insulin pump or continuous glucose monitor (CGM) — devices that could otherwise reshape diabetes management and their quality of life with this condition.

Over the years, industry has touted new innovations that might someday include different levels of stickiness for people to choose from, or even “smart” adhesives that could automatically adjust to an individual’s skin. That may very well be a pipe dream that never materializes, but it shows the level of interest, at least in theory.

Fortunately, a growing body of research has brought more attention to this issue and forced some diabetes device companies to make significant changes to their manufacturing processes and the types of adhesives they choose.

In 2018, a team of healthcare professionals including diabetes care and education specialists (DCES) recognized the problem in a research article on “Preserving Skin Integrity with Chronic Device Use in Diabetes.”

The authors explain how “devices involve a small filament or cannula being inserted under the skin and secured with an external adhesive patch (worn) on the skin (that) varies in size, with tubed infusion sets offering the smallest surface area, and CGMs and patch pumps requiring a larger adhesive body.” They note that insulin pump infusion sets need to be replaced every 2 to 4 days, while CGM sensors are approved by the Food and Drug Administration (FDA) to be worn on the skin for 7 to 14 days.

“With the increasing use of these devices, dermatological concerns are becoming more common in people with diabetes. Skin issues are frequently reported to endocrinologists and diabetes educators in clinical practice, and are a persistent topic in diabetes support groups and social media websites.Few resources are available, however, to guide clinicians on how to comprehensively assess, prevent, and treat skin conditions associated with diabetes device usage,” the authors wrote.

Some of the more common skin complications and allergic reactions include tissue damage and scarring, hypersensitivity, lipodystrophy (uneven distribution of fat), and even infection and more serious wounds.

None of this is a surprise to the myriad PWDs who experience these issues firsthand.

Facebook groups and other social media channels are full of PWDs complaining about rashes or red marks caused by wearing a CGM or insulin pump infusion set. Many include images — sometimes quite graphic — to show the extent of the problem.

But how common is this overall?

Manufactures keep close to their chest when it comes to data about customer service calls relating to adhesives or skin issues. And skimming through “adverse event reports” kept by the FDA to find data can be quite complicated and fruitless, given the complexity of the database.

Some researchers have found that at least 35 percent of diabetes device users experience intermittent skin problems due to irritation from sweating, occlusion and so on under the adhesive.

With it being such a common issue for many PWDs, a Dexcom-affiliated research analysis published in 2018 cited earlier clinical research showing that skin reactions are a significant barrier to people using CGM technology. Specifically, it stated “anecdotal and peer-reviewed reports suggest that adhesive failures or skin reactions are an important reason for discontinuation of CGM.”

At the time, Dexcom pointed out that it had recently (in 2017) changed its manufacturing process to address this problem and reduce skin allergies that were being caused by the ethyl cyanoacrylate contained in their adhesive. After that change, the CGM company reported fewer incidences of skin reactions.

One of the world’s most passionate researchers on this topic in recent years is Dr. Stefanie Kamann, a dermatologist and allergist in Germany, whose son lives with type 1 diabetes (T1D) and experiences these adhesive woes personally.

Her son was diagnosed at age 6 in 2013, and went on an insulin pump and CGM device directly. She says she began noticing a contact allergy to isobornyl acrylate (IBOA), a component of the glue commonly used in many medical supplies and diabetes device components. This allergen has been recognized as a problem for PWDs by the American Academy of Dermatology.

For Kamann’s son, it was the Abbott FreeStyle Libre with a quarter-sized round sensor adhered to skin that caused him problems. He’d get severe skin reactions that made it difficult to wear that device.

Kamann’s research has found that possibly more than two-thirds of patients experience these issues at some point. “They can handle this problem sometimes with skin barrier wipes or skin care creams, but some have more problematic and life-long real allergies.”

In her own dermatology lab, she saw many patients between 2016 and 2020 who experienced allergic skin reactions after using the Abbott FreeStyle Libre, Medtronic Minimed Enlite CGM sensors, and the Omnipod insulin patch pump. That also led to cross-reactions to other devices they used with adhesives, she said.

Kamann’s research on this through the years has connected dots between diabetes devices and the dermatology and allergy and immunology communities, and many of the leading clinical studies tackling this topic cite her work.

Although FDA regulators aren’t fully monitoring these problems or intervening much as some researchers believe they should, there is movement to make the sticky parts of diabetes devices more skin-friendly.

Kamann says she’s observed changes from both Dexcom and Abbott Diabetes Care on the manufacturing process and adhesives it uses in their diabetes devices and supplies, and that’s backed up in clinical studies by her and other researchers across the globe.

San Diego-based Dexcom has certainly been aware of this issue for many years, dating back to the launch of its initial product in 2005. At one point, the CGM company even had a specific technical support page where PWDs could report adhesive issues.

But that changed in 2017, when the company made the change in the adhesive it used to avoid the allergen ethyl cyanoacrylate.

Dexcom sensors manufactured with an expiration date after August 2017 had the new adhesive, but this was never acknowledged by the company anywhere publicly, or even during earnings calls, when investors get updates on new product development. Still, many Dexcom users who had struggled with skin irritations noticed the change almost immediately. They began reporting having fewer or even no rashes or breakouts as they had in the past.

International clinical studies by Kamann and others also confirmed the success of the adhesive change.

In its official FAQ, Dexcom has explained its adhesive makeup this way: “It is a pressure sensitive acrylic adhesive coated on top of a polyester spunlace fabric. The plastic housing is attached to the patch by direct pressure and heat. There is no latex or bovine components in the adhesive.”

Abbott followed Dexcom’s lead and made changes in 2017 after conducting its own clinical study that showed some of the issues PWDs experience from the adhesives. The company also issued a special guide that year to help people navigate adhesive woes.

In 2020, Abbott eliminated IBOA from its adhesives completely. Kamann believes this was a direct result of the growing body of research on this topic by her and colleagues internationally.

While she’s pleased that companies are paying more attention to this issue and some are making changes, Kamann feels it’s a lingering concern that needs more research and continued pressure.

For example, a manufacturing change implemented by Dexcom with the newest model G6 in 2018 — complete with a new auto-inserter — reintroduced adhesive allergies and stickiness challenges for some PWDs.

Kamann says Dexcom changed its adhesive again in 2020 in order to make it stick better and that led even more of her patients to experience contact allergies. She notes that Dexcom only had to ask for a new acrylate or component for the new adhesive from their supplier. But in fact, determining which part of the adhesive is actually problematic can be a long-term research project involving complicated lab tests on different allergens.

That work continues, she adds, but it can take as long as 2 years to even determine which adhesive component might be an issue to press the manufacturer on.

For its part, Dexcom says that it continues to work to improve its adhesive, to give PWDs the best possible CGM experience. Senior public relations manager James McIntosh told DiabetesMine in early 2021 that “with modifications to our adhesive, and an updated G6 transmitter that was approved by the FDA in December 2020, we are already seeing significantly improved sensor wear time and reduced sensor errors.”

But Kamann sees things differently. “The problem will appear as long as things will stick on the skin for more days… Still, there is no transparency about components, and the factories — especially in the USA — do not want to hear too much about the problem,” she told DiabetesMine.

Among the many different medical adhesive wipes and tapes the D-Community uses, Skin Tac and Flexifix Opsite probably top the list as most popular.

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