FDA expedites new insulin pump technology with device approvals

The FDA in February signaled its support for customizable solutions for people with diabetes with two new device approvals designed to improve automated insulin delivery, suggesting that more personalized artificial pancreas systems may become reality sooner rather than later.

The Tandem Diabetes Care t:Slim X2 insulin pump, an alternate controller enabled insulin infusion pump, or ACE insulin pump, is the first interoperable pump approved for children and adults with diabetes by the FDA, meaning it can be used with different components that make up diabetes therapy systems. The device is the first to be classified under a new de novo premarket review pathway, the agency announced in a press release, and allows patients to tailor their diabetes management to their individual device preferences.

Anne L. Peters

“The new review pathway creates a platform for individualization,” Anne L. Peters, MD, professor of clinical medicine at Keck School of Medicine at the University of Southern California, Los Angeles, told Endocrine Today. “Type 1 diabetes is so hard to have. Why shouldn’t people be able to say, ‘I want this brand of pump, and I want this other brand of sensor?’ This is all about patients and allowing them more access and opportunity, more interconnectivity. Patients have already shown us that is what they want with the DIY closed-loop system.” (See “As DIY ‘loopers’ reinvent artificial pancreas, endocrinologists confront safety, liability concerns” on the November issue cover.)

The FDA also granted breakthrough device designation for a personalized, closed-loop insulin pump system currently in development by Medtronic. The new system, according to a Medtronic press release, is designed to automate insulin delivery in a “real-time, adaptable way” while also providing predictive diagnostics unique to the individual.

Richard M. Bergenstal

Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet in Minneapolis, said the two developments suggest that closed-loop insulin delivery “is going to become the standard.”

“This is becoming real,” Bergenstal told Endocrine Today. “Yes, not everyone is going to be able to afford a closed-loop system, and not everyone is going to want to wear it, but it is going to become like continuous glucose monitoring, where you will have to offer it to someone with type 1 diabetes. There is no way a person with diabetes is going to get to 70% time-in-range or an HbA1c of 7% with no hyporglycemia without it.”

Fast tracking new devices

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 for its new closed-loop insulin delivery system, as well as interactive communication regarding device development and clinical trial protocols.

“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 a press release announcing the approval.

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.

Courtney H. Lias

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, 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 said 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.

“We know that diabetes is a complicated disease that has significant impact on the quality of life of patients because of the requirements to closely monitor and carefully tailor treatments,” Lias told Endocrine Today. “We have been actively working with the patient community and manufacturers to safely encourage innovation and development of tools that address this community’s unique needs. The FDA is committed to helping patients have access to innovative and safe technologies that can greatly improve their quality of life. We will continue to do this by advancing new ways to accelerate the development of these medical devices, while strengthening our pre- and post-market tools for overseeing their safety and effectiveness.”

Medtronic has not released details on what the newer, more personalized closed-loop system will offer, but experts have previously spoken of drawbacks with the 670G system, in part due to its “hybrid” nature. As a condition of approval, the FDA required that the closed-loop target be set at 120 mg/dL, with the ability to periodically raise the target to 150 mg/dL to allow increased physical activity, Peters said.

“What the new breakthrough designation means is that they are letting Medtronic accelerate development for a system that does more,” Peters said. “My sense is it is a good thing, because it means whatever Medtronic has in their pocket is more useful.”

Bergenstal said people with diabetes are eager for a closed-loop system that allows them to customize their HbA1c “set point” to accommodate their needs and lifestyle.

“It’s a good sign that there is going to be more competition in the space,” Bergenstal said. “The current artificial pancreas is not quite aggressive enough for something like pregnancy, but a newer system might be.”

Innovations in diabetes technology

Because the FDA’s approval of the t:Slim insulin pump 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 a Feb. 15 press release, potentially helping to advance the technology.

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.

“Interoperability is a trend happening in electronics worldwide, and now this trend has arrived for diabetes devices,” David C. Klonoff, MD, FACP, FRCP, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, California, told Endocrine Today. “Traditionally, a company would receive FDA approval for a stand-alone 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

The ACE insulin pump approval, Peters, said, will help further drive innovation for more accurate sensors, pumps and CGMs that can be used interchangeably.

“Get a smart patient an algorithm and they can make their own closed-loop system, and they do it based on the component parts that they can cobble together,” Peters said. “Every device in the diabetes space needs to be intercompatible with every other device. It lets me say to patients, ‘Let’s choose what works for you.’” – by Regina Schaffer

Disclosures: Bergenstal reports no relevant financial disclosures. Galindo reports he is president of the advanced insulin management division within the diabetes group at Medtronic. Klonoff reports he is a consultant for Ascencia, Eoflow, Lifecare, Novo Nordisk, Roche and Voluntis. 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. Peters reports various financial ties with Abbott, Becton Dickinson, Bigfoot, Boehringer Ingelheim, Dexcom, Eli Lilly, Janssen, Lexicon, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, Sanofi and Science 37.

The FDA in February signaled its support for customizable solutions for people with diabetes with two new device approvals designed to improve automated insulin delivery, suggesting that more personalized artificial pancreas systems may become reality sooner rather than later.

The Tandem Diabetes Care t:Slim X2 insulin pump, an alternate controller enabled insulin infusion pump, or ACE insulin pump, is the first interoperable pump approved for children and adults with diabetes by the FDA, meaning it can be used with different components that make up diabetes therapy systems. The device is the first to be classified under a new de novo premarket review pathway, the agency announced in a press release, and allows patients to tailor their diabetes management to their individual device preferences.

Anne L. Peters

“The new review pathway creates a platform for individualization,” Anne L. Peters, MD, professor of clinical medicine at Keck School of Medicine at the University of Southern California, Los Angeles, told Endocrine Today. “Type 1 diabetes is so hard to have. Why shouldn’t people be able to say, ‘I want this brand of pump, and I want this other brand of sensor?’ This is all about patients and allowing them more access and opportunity, more interconnectivity. Patients have already shown us that is what they want with the DIY closed-loop system.” (See “As DIY ‘loopers’ reinvent artificial pancreas, endocrinologists confront safety, liability concerns” on the November issue cover.)

The FDA also granted breakthrough device designation for a personalized, closed-loop insulin pump system currently in development by Medtronic. The new system, according to a Medtronic press release, is designed to automate insulin delivery in a “real-time, adaptable way” while also providing predictive diagnostics unique to the individual.

Richard M. Bergenstal

Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet in Minneapolis, said the two developments suggest that closed-loop insulin delivery “is going to become the standard.”

“This is becoming real,” Bergenstal told Endocrine Today. “Yes, not everyone is going to be able to afford a closed-loop system, and not everyone is going to want to wear it, but it is going to become like continuous glucose monitoring, where you will have to offer it to someone with type 1 diabetes. There is no way a person with diabetes is going to get to 70% time-in-range or an HbA1c of 7% with no hyporglycemia without it.”

Fast tracking new devices

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 for its new closed-loop insulin delivery system, as well as interactive communication regarding device development and clinical trial protocols.

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“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 a press release announcing the approval.

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.

Courtney H. Lias

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, 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 said 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.

“We know that diabetes is a complicated disease that has significant impact on the quality of life of patients because of the requirements to closely monitor and carefully tailor treatments,” Lias told Endocrine Today. “We have been actively working with the patient community and manufacturers to safely encourage innovation and development of tools that address this community’s unique needs. The FDA is committed to helping patients have access to innovative and safe technologies that can greatly improve their quality of life. We will continue to do this by advancing new ways to accelerate the development of these medical devices, while strengthening our pre- and post-market tools for overseeing their safety and effectiveness.”

Medtronic has not released details on what the newer, more personalized closed-loop system will offer, but experts have previously spoken of drawbacks with the 670G system, in part due to its “hybrid” nature. As a condition of approval, the FDA required that the closed-loop target be set at 120 mg/dL, with the ability to periodically raise the target to 150 mg/dL to allow increased physical activity, Peters said.

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“What the new breakthrough designation means is that they are letting Medtronic accelerate development for a system that does more,” Peters said. “My sense is it is a good thing, because it means whatever Medtronic has in their pocket is more useful.”

Bergenstal said people with diabetes are eager for a closed-loop system that allows them to customize their HbA1c “set point” to accommodate their needs and lifestyle.

“It’s a good sign that there is going to be more competition in the space,” Bergenstal said. “The current artificial pancreas is not quite aggressive enough for something like pregnancy, but a newer system might be.”

Innovations in diabetes technology

Because the FDA’s approval of the t:Slim insulin pump 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 a Feb. 15 press release, potentially helping to advance the technology.

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.

“Interoperability is a trend happening in electronics worldwide, and now this trend has arrived for diabetes devices,” David C. Klonoff, MD, FACP, FRCP, medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, California, told Endocrine Today. “Traditionally, a company would receive FDA approval for a stand-alone 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

The ACE insulin pump approval, Peters, said, will help further drive innovation for more accurate sensors, pumps and CGMs that can be used interchangeably.

“Get a smart patient an algorithm and they can make their own closed-loop system, and they do it based on the component parts that they can cobble together,” Peters said. “Every device in the diabetes space needs to be intercompatible with every other device. It lets me say to patients, ‘Let’s choose what works for you.’” – by Regina Schaffer

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Disclosures: Bergenstal reports no relevant financial disclosures. Galindo reports he is president of the advanced insulin management division within the diabetes group at Medtronic. Klonoff reports he is a consultant for Ascencia, Eoflow, Lifecare, Novo Nordisk, Roche and Voluntis. 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. Peters reports various financial ties with Abbott, Becton Dickinson, Bigfoot, Boehringer Ingelheim, Dexcom, Eli Lilly, Janssen, Lexicon, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, Sanofi and Science 37.