Wednesday was a great day for the diabetes community, Richard Bergenstal, a research clinician at the International Diabetes Center at Park Nicollet, told Medical Device Daily, soon after the FDA approved the first commercial device often referred to as an artificial pancreas.

Medtronic plc's Minimed 670g hybrid closed loop system is now approved for patients 14 years of age and older with type 1 diabetes. The device is designed to adjust insulin levels with little or no input from the user by measuring glucose levels every five minutes.

The regulatory milestone came about three months after Medtronic submitted the pre-market approval (PMA) application for the Minimed 670G in late June and the company said at the time it expected approval sometime next year, with plans to launch the product next spring.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.

Currently the system includes a glucose-monitoring sensor that attaches to the body under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption, the FDA noted.

The company gained access to the artificial pancreas technology through a $3.7 billion acquisition of Minimed Inc. about 15 years ago. Minimed's main product at the time was an external pump, worn on a patient's belt, to administer insulin continuously to people with type 1 diabetes. Since then, Medtronic has advanced the technology by adding an integrated insulin pump and continuous glucose monitoring (CGM) and a low glucose suspend feature.

The CDC estimates that about 5 percent of people with diabetes have type 1 diabetes, also known as juvenile diabetes. This form of the chronic disease is usually diagnosed in children and young adults. Because the pancreas does not make insulin in type 1 diabetes patients, this patient population has to monitor their glucose levels throughout the day and manually give themselves insulin through injection with a syringe, an insulin pen, or insulin pump to avoid becoming hyperglycemic (high glucose levels).

Patients grew impatient Interest in an artificial pancreas system has been so extraordinary among the diabetes community that some patients, frustrated by how long it has taken for the technology to reach the market, have built their own kits and shared tutorials about it online. At the American Diabetes Association's (ADA) annual meeting in June, the patient-driven Open Artificial Pancreas System project, featured in a late-breaking poster session, reported quantitative and qualitative measures of 40 do-it-yourself diabetes patients.

"I've been having conversations with patients asking 'where is the artificial pancreas' and 'where is the closed-loop system' ... literally for decades," Bergenstal said. "So I was excited to see the community say 'we're going to push ahead with this' but I was equally excited to see the major companies weren't waiting either."

Bergenstal, who served as principal investigator on the study that supported Medtronic's PMA application, said the technology will likely continue to evolve as the community pushes the industry to deliver an even better system, but FDA approval of the Minimed 670G is "really a major advancement" in the management of type 1 diabetes, he said. "It's one of those events that some of us have been waiting for 30 years."

Patients and doctors alike have waited decades for industry to introduce better insulin pumps, better glucose-monitoring sensors, and – finally – a system that allows the two to communicate with each other to adjust the insulin to keep a patient's blood sugar in the target range more consistently, Bergenstal said.

FDA approval was supported by data from 123 participants with type 1 diabetes. For the first two weeks of the trial, participants did not use the system's hybrid closed loop. After two weeks, patients in the trial used the hybrid closed loop feature as often as possible for the three months. The trial demonstrated safety, the agency noted, as no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia (low glucose levels) were reported.

According to results presented at ADA, patients spending three months on the hybrid closed loop system saw a 0.5 percent reduction in A1c; a 44 percent reduction in time spent with low blood glucose; and a 40 percent decline in the time spent in dangerous hypoglycemia. The ADA noted that about 80 percent of trial patients wanted to keep using the device through the FDA's continued access program.

The agency is requiring the Dublin, Ireland-based company to run a post-market study to better understand how the device performs in real-world settings. Medtronic also has ongoing studies to evaluate the device in younger diabetic children, ages 7 to 13. The FDA said the Minimed 670G would not be safe for children age 6 or younger or in patients who require less than eight units of insulin a day.

One of Bergenstal's biggest learning take-aways from his experience with the 15 trial patients enrolled at his center was that the doctors participating in the study were more concerned about numbers and wanted to see if they could get more blood sugar levels within the target range safely while patients just enjoyed the quality of life they achieved with the device.

"We're all about numbers and they're all about 'I can finally live my life and let the system do some of the work'," he said.

Throughout the trial, Bergenstal repeatedly heard from parents of 14-year-old diabetes patients who said the Minimed 670G allowed them to get a full night's sleep for the first time in 10 years. Parents who have spent the last decade waking up to check their child's blood sugar were able to let the system take over that night monitoring duty, he said.

"We also saw people say 'I can have a few minutes of the day where I'm not constantly thinking about my diabetes'," Bergenstal added. "This is the first step of a closed loop system we've been waiting for and it's only going to get better as refinements are made and younger populations are studied ... my only hope is that those who need it will get access to it that will really let a large number of people take advantage of this system."

Asking patients for more patience

Patients will have to be patient for just a while longer, however, as Medtronic said it will not release the Minimed 670G until next spring, with system availability increasing over time from that point forward. The company said that timeline ensures payer coverage, market and manufacturing readiness, and appropriate training of employees, clinicians, educators, and patients on the new system.

As it moves toward that initial launch, however, Medtronic said Minimed 630G system users will be eligible for a priority access program to the 670G system because those patients are already familiar with the Minimed hardware platform, which will make it easier for them to transition to the new system. The company expects to get regulatory approval for the device outside the U.S. market next summer.

Wells Fargo Securities' Larry Biegelsen said he expects the latest Minimed system to help drive an acceleration in Medtronic's U.S. diabetes growth from the low-single-digits seen in the first quarter. The analyst currently models U.S. diabetes growth of 10 percent for the second half of fiscal year 2017, driven primarily by the 670G launch.

Abbott's CGM also approved

Medtronic's approval shifted some attention away from Abbott Laboratories on Wednesday when the FDA also approved Abbott's Freestyle Libre Pro CGM. While Abbott's approval is for a device that will only be used by doctors, rather than patients, as a way of spotting patterns and trends within a patient's glucose levels.

Biegelsen said in a research note on Abbott's approval that the professional CGM market is relatively small – less than $100 million – but is growing fast at a rate of about 65 percent to 70 percent. The analyst said the FDA approval of Libre Pro without factory calibration is a positive read-through for Abbott's more important consumer version of Libre, which the company recently filed for the FDA to review. Even so, Biegelsen said the agency likely has a higher bar for approving a consumer product than it does for a health care professional device.

Abbott is expected to launch the Libre Pro in the coming weeks with a significantly discounted price tag compared to other CGMs on the market. Doctors will only need to buy one reader for about $65 to scan an unlimited number of patients. This is a notable departure from the current CGM paradigm in which each patient is required to have a CGM – representing a large upfront investment for doctors, Biegelsen said.

The analyst added that Libre is Abbott's most important diabetes pipeline product and that adoption in Europe has been strong so far. He predicted Abbott's diabetes sales will come in around $1.138 billion this year and increase to $1.209 billion in 2017.

With Abbott's Freestyle Libre Pro, a small, round sensor is placed on the back of a patient's upper arm in a clinic setting and the sensor is held in place with a self-adhesive pad for up to 14 days. The patient does not need to interact with the device or draw blood via a fingerstick to calibrate the sensor.

The sensor is designed to continuously measure glucose in interstitial fluid through a filament inserted just under the patient's skin, recording glucose levels every 15 minutes, capturing up to 1,340 glucose results for up to 14 days, giving the patient's doctor comprehensive data for a complete glycemic profile of that patient. After 14 days, the doctor uses a Freestyle Libre Pro reader to scan the sensor and download the data during a follow-up office visit.