FDA warns unauthorized devices for diabetes management are dangerous, and devices like pumps, CGMs and automated insulin delivery systems should be used as manufacturers intended.
In recent news, the U.S. Food and Drug Administration (FDA) has warned people with diabetes about using unauthorized DIY devices for diabetes management, warning that they can cause harm or even death in patients with diabetes. Hacked, “DIY”, or otherwise altered technology used within devices could be fatal, according to the FDA. These devices have not been reviewed by the FDA and falsely ensure to provide patients with safety guarantee and effectiveness. Incorrect glucose level readings or unsafe insulin doses can occur from using these unauthorized devices, which can lead to seeking immediate medical attention or death.
These mHealth management devices are classified as continuous glucose monitoring systems (CGMs), insulin pumps, and automated insulin dosing systems. People with diabetes consider these devices helpful when managing their diabetes and matching insulin to their lifestyle. A CGM keeps tracks of the glucose levels throughout the day and night, by a sensor that is inserted under the skin. The sensor is combined with software that codes the glucose level for users to read. Insulin pumps are small devices placed under the skin that replace the need for periodic injections by delivering regular or rapid-acting insulin continuously throughout the day using a catheter. Insulin pumps can help keep blood glucose levels within target ranges. An automated insulin dosing system is a system that automatically supplies insulin doses based on blood glucose measurements from a glucose monitoring system.
The FDA has expounded upon the fact that using unauthorized or altered devices may lead to severely low blood glucose levels, coma, diabetic ketoacidosis, or death. The FDA is aware that there are manufacturers who have illegally marketed unauthorized devices for diabetes management, which have not been reviewed by the agency for safety and effectiveness.
Additionally, there has been suspicion that mobile health (mHealth) devices have been hacked to steal data and cause harm. People with access to the device can alter or tailor how the software works to try to save time and money with their diabetes management. A report was received by the FDA of glucose values that were sent from an unauthorized continuous glucose monitoring system to an unauthorized automatic insulin dosing device to determine how much insulin to receive. The automated insulin dosing device released too much insulin to the person based on the incorrect high glucose level coming from the continuous glucose monitoring system, resulting in insulin overdose. The FDA explained how the two devices combined were not tested for compatibility and led to undesired outcomes.
An authorized automated insulin system will contain a specific continuous glucose monitoring system, with a specific insulin pump, and algorithm. In an unauthorized automated insulin system, the algorithm programmed on the unauthorized device may return incorrect glucose values. When patients alter and combine these unauthorized devices that are not compatible to other unauthorized devices it presents new risks that the FDA has not assessed for effectiveness and safety.
The FDA recommends all patients with diabetes who use diabetes management devices talk with their healthcare providers about their devices and how to use them properly. Also, the FDA suggests that patients should use devices that are FDA approved and authorized for sale in the U.S.
- Be aware the FDA has not assessed the effectiveness and safety of mHealth devices for diabetes management.
- Use of unauthorized devices and systems can give patients incorrect glucose values or levels and lead to harmful risks including death.
- Clinicians should be aware that patients should only use diabetes management devices that are authorized by FDA for sale in the U.S.
- Center for Devices and Radiological Health. “FDA Warns Against Diabetes Management Devices Not Authorized for Sale.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/safety-communications/fda-warns-people-diabetes-and-health-care-providers-against-use-devices-diabetes-management-not.
- mHealthIntelligence. “FDA Cracks Down on DIY MHealth Platforms for Diabetes Care Management.” MHealthIntelligence, 20 May 2019, mhealthintelligence.com/news/fda-cracks-down-on-diy-mhealth-platforms-for-diabetes-care-management.
- Douros, Antonios, et al. “Sulfonylureas as Second Line Drugs in Type 2 Diabetes and the Risk of Cardiovascular and Hypoglycaemic Events: Population Based Cohort Study.” The BMJ, British Medical Journal Publishing Group, 18 July 2018, www.bmj.com/content/362/bmj.k2693.
- Sola, Daniele, et al. “Sulfonylureas and Their Use in Clinical Practice.” Archives of Medical Science : AMS, Termedia Publishing House, 12 Aug. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4548036/.
Maya Rudolph, Florida A&M University, College of Pharmacy & Pharmaceutical Sciences, PharmD Candidate