Diabetes treatment costs have gone up, sending people to look for cheaper options.
The Food and Drug Administration (FDA) is warning consumers against using unapproved devices for managing diabetes because of the risk of serious adverse health effects.
The announcement comes in response to an incident in which a patient suffered an insulin overdose after using one such device.
“By using products that have not been reviewed by the agency for safety and effectiveness, patients with diabetes may be putting themselves at risk for serious injury or even death,” said Dr. Jeff Shuren, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement.
Despite the apparent risks, unapproved devices may appear attractive to some people because of the cost or availability of FDA-approved devices.
Diabetes management devices include multiple systems that can work in concert with one another to monitor blood glucose and deliver insulin to the bloodstream.
A continuous glucose monitoring system uses data from a sensor embedded under the skin to track glucose levels.
An insulin pump is attached to the skin and delivers insulin into the bloodstream via a catheter.
An automated insulin dosing system is designed to do both: measure glucose from a monitoring system and automatically appropriate doses of insulin.
In some cases, devices for managing diabetes are only designed to work together as a whole system; in other cases parts are designed so that they can essentially be swapped out for other approved parts — known as “interoperability.”
The FDA authorized the first-ever interoperable insulin pump in February 2019. The agency has stated that these devices give people greater freedom to “tailor their diabetes management to their individual device preferences.”
However, the FDA warns that unapproved versions of these devices can be dangerous even if used within approved systems.
The market for unapproved interoperable devices — where parts claim they can be added to approved devices, but have not been vetted — has also led to a scenario in which some patients are creating their own ad hoc diabetes management systems by wiring together in a chain interoperable parts and systems.
These do-it-yourself (DIY) systems use an insulin pump, continuous glucose monitor (CGM), and insulin dosing algorithm to create a closed-loop system similar to that of the current FDA approved systems, Dr. Kevin Pantalone, DO, an endocrinologist at Cleveland Clinic, told Healthline.
However, diabetes management devices rely on complex algorithms to convert blood glucose data received from the sensor into values that are readable by insulin dosing devices. Pairing different devices together can therefore result in inaccurate and potentially dangerous doses of insulin.
“There are numerous algorithms and devices out there that can be paired by patients to develop a DIY system. This is a concern, as these algorithms and pairings have not been studied in controlled trials, so their effectiveness and more importantly their safety, are largely unknown and based on anecdotal experiences,” Pantalone said.
In a safety communication issued by the FDA, it warned that use of these devices can result in complications that may require medical intervention or hospitalization including low blood sugar, coma, diabetic ketoacidosis, and death.
This is not the first time the FDA has warned people with diabetes about unapproved or “gray market” products for managing the condition. In April 2019, the agency issued a statement discouraging consumers from purchasing pre-owned test strips or unauthorized test strips for blood glucose monitoring.
The agency found that unauthorized test strips were frequently sold through online marketplaces including Amazon, eBay, and Craigslist.
But the FDA was less forthcoming in their new warning about where people were able to purchase unauthorized diabetes management devices.
In an email to Healthline, a spokesperson for the FDA declined to comment further on the names of any brands, parts, manufacturers, or vendors of the unauthorized devices, explaining that the FDA does not comment on specific companies.
The spokesperson also declined to comment on where the unauthorized devices are coming from and whether they were being imported or manufactured domestically.
Within the last year, there’s been growing concern in the diabetes community about access to affordable care, treatment, and supplies. Some have actively championed caravanning to Canada for affordable insulin.
The use of DIY or unauthorized diabetes management systems among some people could be viewed as yet one more symptom of a healthcare system in which necessary and life-saving treatment is out of reach financially for some.
Many people, particularly those with type 1 diabetes, have turned to these types of DIY systems because they can’t afford the FDA-approved systems or they seek better, individualized blood sugar control,” Pantalone said.
“People with type 1 diabetes don’t get a vacation from their disease — it’s a 24-hour-a-day job,” Pantalone said. “But some people with diabetes seek out these DIY systems because they can provide a short amount of time away from the minute-to-minute burden of managing diabetes.”
After a person with diabetes suffered an insulin overdose using an unapproved diabetes management device, the FDA is warning consumers against using these devices because of the risk of serious adverse health effects.
The warning comes as the diabetes community is growing more concerned with the affordability of treatment for the condition. Other people with diabetes have taken to creating their own DIY insulin management devices because they can’t afford FDA-approved options.