Perspective

FDA grants breakthrough device designation for personalized, closed-loop insulin pump

The FDA on Tuesday granted breakthrough device designation for a personalized, closed-loop insulin pump system that is currently in development, according to a press release from Medtronic.

The personalized, closed-loop technology, according to Medtronic, is designed to automate insulin delivery in a real-time, adaptable way while also providing predictive diagnostics unique to the individual, with a goal of dramatically simplifying diabetes management.

The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

“We are excited to receive the breakthrough device designation from the FDA, as it will help us deliver this broadly anticipated innovation to patients much sooner than expected,” Alejandro Galindo, president of the advanced insulin management division within the diabetes group at Medtronic, said in the release. “We believe the personalized closed-loop system will be transformational for diabetes management, and the personalized nature of the algorithm clears the path to a true closed-loop system. We have a long history of partnership with the FDA and look forward to another successful collaboration with the agency to bring this important innovation to patients.”

Medtronic stated that the recent acquisition of Nutrino Health, known for expertise in nutrition data science, will play a key role in the accelerated development of the technology.

Fast-tracking new devices

As previously reported by Endocrine Today, the FDA approved Medtronic’s MiniMed 670G hybrid closed-loop insulin delivery system in September 2017 for use in patients aged at least 14 years. The agency later extended approval of the 670G to younger individuals aged 7 to 13 years with type 1 diabetes.

The FDA’s new breakthrough device designation follows an effort on the agency’s part to expedite the availability of therapies like automated insulin delivery. In an interview in November, Courtney H. Lias, PhD, director of the division of chemistry and toxicology devices in the Office of In Vitro Diagnostics and Radiological Health at FDA, told Endocrine Today that the 670G closed-loop system was approved 3 years earlier than Medtronic expected, with rapid approval in 103 days. That quicker pace, she said, followed monthly meetings between the agency and the manufacturer for 2 years to ensure an efficient regulatory review of the device and its clinical data.

“Patients with diabetes deserve to feel like they do not have to resort to using unapproved DIY devices to get the help they feel they need,” Lias said at the time. “To that end, we have been working to speed up the availability of these important therapies. We succeeded in speeding up the availability of the first approved system, and we are also working on novel regulatory pathways to speed up the availability of more approved automated insulin delivery systems.”

Innovations in diabetes technology

On Feb. 15, the FDA also 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.

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, FDA Commissioner Scott Gottlieb, MD, said in the Feb. 15 release, 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 postmarket tools for determining the safety and effectiveness of these new technologies,” Gottlieb said. – by Regina Schaffer

Disclosures: Galindo reports he is president of the advanced insulin management division within the diabetes group at Medtronic. Lias reports she is the director of the Division of Chemistry and Toxicology Devices in the office of In Vitro Diagnostics and Radiological Health at the FDA.

The FDA on Tuesday granted breakthrough device designation for a personalized, closed-loop insulin pump system that is currently in development, according to a press release from Medtronic.

The personalized, closed-loop technology, according to Medtronic, is designed to automate insulin delivery in a real-time, adaptable way while also providing predictive diagnostics unique to the individual, with a goal of dramatically simplifying diabetes management.

The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

“We are excited to receive the breakthrough device designation from the FDA, as it will help us deliver this broadly anticipated innovation to patients much sooner than expected,” Alejandro Galindo, president of the advanced insulin management division within the diabetes group at Medtronic, said in the release. “We believe the personalized closed-loop system will be transformational for diabetes management, and the personalized nature of the algorithm clears the path to a true closed-loop system. We have a long history of partnership with the FDA and look forward to another successful collaboration with the agency to bring this important innovation to patients.”

Medtronic stated that the recent acquisition of Nutrino Health, known for expertise in nutrition data science, will play a key role in the accelerated development of the technology.

Fast-tracking new devices

As previously reported by Endocrine Today, the FDA approved Medtronic’s MiniMed 670G hybrid closed-loop insulin delivery system in September 2017 for use in patients aged at least 14 years. The agency later extended approval of the 670G to younger individuals aged 7 to 13 years with type 1 diabetes.

The FDA’s new breakthrough device designation follows an effort on the agency’s part to expedite the availability of therapies like automated insulin delivery. In an interview in November, Courtney H. Lias, PhD, director of the division of chemistry and toxicology devices in the Office of In Vitro Diagnostics and Radiological Health at FDA, told Endocrine Today that the 670G closed-loop system was approved 3 years earlier than Medtronic expected, with rapid approval in 103 days. That quicker pace, she said, followed monthly meetings between the agency and the manufacturer for 2 years to ensure an efficient regulatory review of the device and its clinical data.

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“Patients with diabetes deserve to feel like they do not have to resort to using unapproved DIY devices to get the help they feel they need,” Lias said at the time. “To that end, we have been working to speed up the availability of these important therapies. We succeeded in speeding up the availability of the first approved system, and we are also working on novel regulatory pathways to speed up the availability of more approved automated insulin delivery systems.”

Innovations in diabetes technology

On Feb. 15, the FDA also 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.

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, FDA Commissioner Scott Gottlieb, MD, said in the Feb. 15 release, 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 postmarket tools for determining the safety and effectiveness of these new technologies,” Gottlieb said. – by Regina Schaffer

Disclosures: Galindo reports he is president of the advanced insulin management division within the diabetes group at Medtronic. Lias reports she is the director of the Division of Chemistry and Toxicology Devices in the office of In Vitro Diagnostics and Radiological Health at the FDA.

    Perspective
    David C. Klonoff

    David C. Klonoff

    These are important developments and important steps forward. One of the concerns many patients and clinicians have had was that they would like the components of an artificial pancreas system to be interoperable. That way, a person could use a pump from one company, a continuous glucose monitor from a second, a blood glucose monitor from a third and, possibly, certain types of software from a fourth company. When closed-loop technology first became available, it appeared the only way to have a system that was safe, effective and cybersecure was if one company made all of the pieces. However, there are advantages for patients who prefer putting components together from different companies.

    Interoperability is a trend happening in electronics worldwide, and now this trend has arrived for diabetes devices. Traditionally, a company would receive FDA approval for a standalone product, but with interoperability, the FDA developed new pathways for so-called integrated CGM, or iCGM, and now the alternate controller enabled infusion pump, or ACE insulin pump. Right now, there is one iCGM on the market and one ACE insulin pump on the market, but I’m sure we’ll see others soon.

    • David C. Klonoff, MD, FACP, FRCP
    • Medical Director, Diabetes Research Institute, Mills-Peninsula Medical Center

    Disclosures: Klonoff reports he is a consultant for Ascensia, Eoflow, Lifecare, Novo Nordisk, Roche and Voluntis.