FDA approves interoperable insulin pump under new regulatory pathway

The FDA on Thursday approved marketing of the first insulin pump with interoperable technology for children and adults with diabetes, the first device to be classified under a new de novo premarket review pathway, the agency announced in a press release.

The Tandem Diabetes Care t:Slim X2 insulin pump, an alternate controller enabled infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences, according to the FDA. Diabetes therapy systems may be composed of an ACE insulin pump and other compatible medical devices, including automated insulin dosing systems, continuous glucose monitors, blood glucose meters or other electronic devices used for diabetes management.

“We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” FDA Commissioner Scott Gottlieb, MD, said in the release. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently.”

Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, Gottlieb said, potentially helping to advance the technology.

“We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies,” Gottlieb said.

The interoperable t:Slim X2 pump works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices, such as automated insulin delivery or AID systems; or, when not connected to other devices, the interoperable t:Slim X2 pump can be used to infuse insulin on its own. AID systems typically consist of a pump, CGM and software to control the system.

Increased flexibility

In a press release from Tandem Diabetes Care, President and CEO Kim Blickenstaff said the new FDA classification will provide more flexibility as the company makes improvements to current products and collaborates with other companies to develop automated insulin delivery systems.

“This further establishes the role Tandem Diabetes Care has taken as a key innovator in the insulin pump industry, having launched the first touchscreen pump in the United States, the first pump capable of remote feature updates, the first pump approved as [integrated] CGM compatible, and now the first in this new interoperable pump category,” Blickenstaff said in the release.

The change comes at a time when a small but growing group of people with type 1 diabetes are choosing to created their own closed-loop automated insulin delivery systems. “Loopers,” as DIY artificial pancreas builders have become known, are a growing online community of savvy, engaged patients and parents who are “hacking” older insulin pumps to build closed-loop insulin delivery systems that are fully customizable.

In November, Tidepool, a nonprofit, open-source technology company that provides a cloud platform for diabetes device data, launched a project to officially support Loop, an app designed for do-it-yourself automated insulin delivery devices.

The initiative, first announced on the company’s blog Oct. 8 and reported by Endocrine Today, includes plans to submit the app to the FDA and an observational study of “loopers,” which began in November. That project is the first of its kind, Tidepool founder, CEO and president Howard Look said at the time, and would allow people with diabetes to potentially create their own closed-loop insulin delivery system using the latest, in-warranty insulin pumps and continuous glucose monitors — no “hacking” of older devices required.

New criteria

Insulin pumps to date have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system (class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable with other diabetes device components, the pump was reviewed through the de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices of a new type, according to the FDA.

Along with the new authorization, the FDA is establishing special controls that will outline requirements for ensuring the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance, according to the agency. These special controls, when met along with general controls, are designed to provide reasonable assurance of safety and effectiveness.

The FDA’s action also created a new regulatory classification. Future ACE insulin pumps that comply with the general and special controls can now go through 501(k) clearance, a more efficient premarket review.

The FDA reviewed interoperable t:Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.

In June, the FDA approved the t:slim X2 Insulin Pump with Basal-IQ, a predictive low-glucose suspend feature that halts insulin delivery when a glucose drop into hypoglycemic range is anticipated. As Endocrine Today reported, the predictive algorithm calculates glucose levels 30 minutes into the future. When low glucose level is expected, the device suspends insulin delivery until glucose level begins to rise again, according to the release.

Risks associated with use of the interoperable t:Slim X2 pump are similar to other infusion pumps and may include infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration). Other risks can include blockages and air bubbles in the tubing, which can affect drug delivery. Risks that could result from incorrect drug delivery include hypoglycemia, hyperglycemia and diabetic ketoacidosis.

The FDA noted that risks associated with connected ACE insulin pumps can include incorrect drug delivery as a result of loss of communication between devices, such as the pump misunderstanding commands it receives, or cybersecurity vulnerabilities. – by Regina Schaffer

Disclosures: Blickenstaff is president and CEO of Tandem Diabetes Care. Gottlieb is commissioner of the FDA. Look is founder, president at CEO of Tidepool.

The FDA on Thursday approved marketing of the first insulin pump with interoperable technology for children and adults with diabetes, the first device to be classified under a new de novo premarket review pathway, the agency announced in a press release.

The Tandem Diabetes Care t:Slim X2 insulin pump, an alternate controller enabled infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences, according to the FDA. Diabetes therapy systems may be composed of an ACE insulin pump and other compatible medical devices, including automated insulin dosing systems, continuous glucose monitors, blood glucose meters or other electronic devices used for diabetes management.

“We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” FDA Commissioner Scott Gottlieb, MD, said in the release. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently.”

Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, Gottlieb said, potentially helping to advance the technology.

“We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies,” Gottlieb said.

The interoperable t:Slim X2 pump works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices, such as automated insulin delivery or AID systems; or, when not connected to other devices, the interoperable t:Slim X2 pump can be used to infuse insulin on its own. AID systems typically consist of a pump, CGM and software to control the system.

Increased flexibility

In a press release from Tandem Diabetes Care, President and CEO Kim Blickenstaff said the new FDA classification will provide more flexibility as the company makes improvements to current products and collaborates with other companies to develop automated insulin delivery systems.

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“This further establishes the role Tandem Diabetes Care has taken as a key innovator in the insulin pump industry, having launched the first touchscreen pump in the United States, the first pump capable of remote feature updates, the first pump approved as [integrated] CGM compatible, and now the first in this new interoperable pump category,” Blickenstaff said in the release.

The change comes at a time when a small but growing group of people with type 1 diabetes are choosing to created their own closed-loop automated insulin delivery systems. “Loopers,” as DIY artificial pancreas builders have become known, are a growing online community of savvy, engaged patients and parents who are “hacking” older insulin pumps to build closed-loop insulin delivery systems that are fully customizable.

In November, Tidepool, a nonprofit, open-source technology company that provides a cloud platform for diabetes device data, launched a project to officially support Loop, an app designed for do-it-yourself automated insulin delivery devices.

The initiative, first announced on the company’s blog Oct. 8 and reported by Endocrine Today, includes plans to submit the app to the FDA and an observational study of “loopers,” which began in November. That project is the first of its kind, Tidepool founder, CEO and president Howard Look said at the time, and would allow people with diabetes to potentially create their own closed-loop insulin delivery system using the latest, in-warranty insulin pumps and continuous glucose monitors — no “hacking” of older devices required.

New criteria

Insulin pumps to date have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system (class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable with other diabetes device components, the pump was reviewed through the de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices of a new type, according to the FDA.

Along with the new authorization, the FDA is establishing special controls that will outline requirements for ensuring the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance, according to the agency. These special controls, when met along with general controls, are designed to provide reasonable assurance of safety and effectiveness.

PAGE BREAK

The FDA’s action also created a new regulatory classification. Future ACE insulin pumps that comply with the general and special controls can now go through 501(k) clearance, a more efficient premarket review.

The FDA reviewed interoperable t:Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.

In June, the FDA approved the t:slim X2 Insulin Pump with Basal-IQ, a predictive low-glucose suspend feature that halts insulin delivery when a glucose drop into hypoglycemic range is anticipated. As Endocrine Today reported, the predictive algorithm calculates glucose levels 30 minutes into the future. When low glucose level is expected, the device suspends insulin delivery until glucose level begins to rise again, according to the release.

Risks associated with use of the interoperable t:Slim X2 pump are similar to other infusion pumps and may include infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration). Other risks can include blockages and air bubbles in the tubing, which can affect drug delivery. Risks that could result from incorrect drug delivery include hypoglycemia, hyperglycemia and diabetic ketoacidosis.

The FDA noted that risks associated with connected ACE insulin pumps can include incorrect drug delivery as a result of loss of communication between devices, such as the pump misunderstanding commands it receives, or cybersecurity vulnerabilities. – by Regina Schaffer

Disclosures: Blickenstaff is president and CEO of Tandem Diabetes Care. Gottlieb is commissioner of the FDA. Look is founder, president at CEO of Tidepool.