FDA Warns Against Use of Unauthorized Diabetes Devices

Miriam E. Tucker

May 17, 2019

UPDATED with comments May 21, 2019 // The US Food and Drug Administration (FDA) has issued a warning against the use of unauthorized diabetes devices, including insulin pumps and continuous glucose monitors (CGMs), as well as other nonapproved devices and algorithms used to create systems for automated insulin delivery.

"These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death," according to the FDA statement.

The warning followed a case report of a patient using a system comprising an unauthorized insulin dosing device that receives electronic signals from an FDA-authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. The system gave the patient too much insulin "in response to repeated incorrect high glucose values," the FDA report says, and the patient required medical intervention.

"These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility," the FDA warns.   

For healthcare providers, the FDA advises, "be aware that your patients should only use diabetes management devices the FDA has authorized for sale in the U.S. and should use them according to manufacturer instructions."

If patients experience adverse events associated with the use of any diabetes management device — authorized or unauthorized — clinicians are advised to report them to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Asked for his thoughts, David Ahn, MD, program director at the Mary and Dick Allen Diabetes Center, Hoag Health Center, Newport Beach, California, told Medscape: "I believe extremely few (if any) endocrinologists are recommending DIY [do-it-yourself] systems to patients, but many endocrinologists continue to work with DIY patients, provided the patients initiate and are aware of the risks they take on by using an unapproved DIY system.

"The FDA's warning will serve as a good cautionary tale and important reminder for clinicians to ensure and document that their patients fully understand these risks, but I don't expect doctors who previously work with DIY patients to completely change course and stop doing so," he added.

The DIY Community and JDRF Respond

The warning prompted a response from three developers of DIY insulin delivery systems, such as described in previous Medscape reports. This "Open Artificial Pancreas (OpenAPS)" movement was launched in 2015, when individuals in the type 1 diabetes community began hacking into older FDA-approved insulin pumps and developed open-source code to allow them to communicate with FDA-approved CGMs in order to "loop" for semiautomated insulin delivery. Estimates suggest that, worldwide, thousands of patients are now using such systems. 

In a joint statement issued on Twitter, the core developers of Loop, OpenAPS, and AndroidAPS said "FDA is aware of the DIY community. This announcement brings up something very important we need to address; an opportunity for the DIY community to double down on its commitment to radical transparency and responsibility." 

According to the DIY groups' statement, the case report in question was from outside of the United States, and the patient has since recovered.

The statement says in bold, "We want you to report adverse events on DIY systems, if and when they occur. We do not support any efforts to minimize or avoid discussing/reporting adverse events. Openly sharing — including any potential issues — is an equally important part of the 'open' aspects of the DIY diabetes community."  

In a statement sent to Medscape Medical News, JDRF president and chief executive officer Aaron Kowalski, PhD, said in part, "A growing number of people in the [type 1 diabetes (T1D)] community have benefitted from [DIY] automated insulin delivery approaches. Today's warning from the FDA to not use unapproved and unauthorized devices for diabetes management is not unexpected — when the agency receives reports of adverse events, it is not uncommon for it to issue warnings.

"We encourage the T1D community to report problems with DIY and other devices when they occur and for the agency to share information with the public as needed. JDRF believes every person who considers DIY approaches should weigh the risks and benefits from their own perspective.

"Our priority at JDRF is to enable more options that can improve the lives of people with diabetes, including versions of innovative DIY approaches that have been reviewed and approved by the FDA," he concludes.

Ahn stressed to Medscape: "The DIY community deserves the highest praise for putting patients first and bringing interoperability and innovation to market, especially when it comes to automated insulin delivery.

"However, I do share the FDA's concern that patient safety can be at risk, especially as growing hype and improved DIY tools make experimentation more accessible to a wider and potentially more vulnerable audience. Moving forward, it's important that clinicians and people with diabetes not have a false sense of security when relying on hybrid closed loops, regulated or not."

Since the DIY movement started, the FDA has approved several semiautomated insulin delivery systems and their components, including Medtronic's MiniMed 670G hybrid closed-loop insulin delivery system, the t:slim X2 Insulin Pump with Basal-IQ technology (Tandem Diabetes Care), Tandem's interoperable t:slim X2 "alternate controller enabled (ACE) infusion pump," and the Dexcom G6 integrated continuous glucose monitoring (iCGM) system.

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