For the first time ever, people with diabetes in the United States will have access to a device that can automatically shut off insulin delivery if your blood sugars dip too low.
On Friday, Medtronic Diabetes announced that the FDA has approved its next-generation 530G model combo insulin pump and CGM (continuous glucose monitor) that shuts off insulin for up to two hours once you hit a pre-set low blood sugar threshold. And the FDA approval was a package deal, including the long-awaited Enlite sensor that's more accurate and more comfortable to wear, for six days instead of three!
But hold up, PWDs in the States: don't think about calling this new system the Paradigm Veo, as it's been known overseas ever since it hit that market in 2009. No, in the U.S. this finally-approved device functions ever-so-slightly differently and will simply be known as the Minimed 530G with Enlite. Maybe not the sexiest name, but I for one am willing to look past the confusing numerical name for the big advantage this device offers -- automatic safety shut-off of insulin, known internationally as Low-Glucose Suspend (LGS).
YES, it automatically senses when you're low and not responding, and does something about it! How awesome is that?!
Medtronic submitted this system to the FDA in June 2012, and the agency has been considering this CGM-pump as part of an entirely new category of device, Threshold Suspend Devices. Now with the FDA's Pre-Market Approval (PMA), the 530G becomes the only device of its kind available in the U.S., and a key first stepping stone to the fully-closed loop systems under development.
We were surprised, however, that Medtronic itself and the mainstream media are referring to the 530G as a first-ever Artificial Pancreas. Even if it does have an automated function that can suspend insulin -- which is a huge step forward, of course -- that doesn't qualify it as a bona fide artificial pancreas, given that it doesn't yet automate insulin dosing or have the ability to predict lows or do anything about hyperglycemia.
The most notable difference between Europe's Veo and the new U.S. version 530G is the range that triggers insulin suspension -- it's 60-90 mg/dL here in the States, but a broader 40-110 mg/dL for the Veo in Europe due to differing regulatory requirements. The company tells us there are also some other differences in how the control algorithms function, but really the other biggest noticeable difference is actually the name.
Most Medtronic customers refer to their pumps as 523 or 723, but those are the model numbers rather than the pump names -- Paradigm REAL-Time and Paradigm Revel. But this new pump's name is all about the numbers (and a letter!) -- 530G. Doesn't exactly roll of the tongue, does it?
Why such a cryptic name? Here are the reasons for the numbers, Medtronic tells us:
- 5 - it's their fifth generation of pump (and now the 13th pump product the company's made since its very first one in 1983)
- 30 - the three represents the sensor iteration, with the first offering wireless glucose meter linking and the second integrateding with CGM; now, this third gen links with LGS and will eventually be predictive and eventually fully closed loop
- G - and of course, this stands for Glucose Sensing (gotcha)
Some things won't change, though. With the 530G, the same 180-unit and larger 300-unit reservoirs can be used, along with the same infusion sets as with past Medtronic pumps.
As mentioned, with the 530G approval comes the long-awaited next-generation CGM sensor called Enlite (available overseas since 2011). Those of us who've used the previous Medtronic CGM sensor refer to it as "the harpoon" since it sports a scary-long insertion needle that can often be painful, and the unit often flops and pulls a bit during wear, causing more discomfort. And many of us haven't found it to be the most accurate, especially those of us who've been able to compare it to Dexcom's newer G4 CGM.
So we're happy to report that Medtronic's new Enlite sensor has these advantages over their previous model:
- 6-day wear-time, rather than three!
- supposedly less painful
- sensor size 38% shorter in length, 69% smaller overall
- 31% more accurate than the previous Medtronic sensor generation
- comes with a brand new inserter called the Enlite Serter that puts the new sensor in at a (more comfortable) 90-degree angle, and you never have to see the needle
The Enlite got approval for sale in Canada in mid-February.
btw, as of now, the 530G will not communicate with the MySentry remote CGM monitoring system because the FDA didn't clear it to communicate wirelessly. But that's something Medtronic plans to apply for soon.
Who'll Get It and How
Sadly right now, the new 530G is not kid-approved -- it's not labeled for anyone younger than 16. Some parents may feel cheated because they purchased a new Paradigm pump within the past year and enrolled in a tech upgrade program but are now being told it won't be honored for kids under 16. But Medtronic has post-market clinical studies underway now to help secure approval for ages 2 and up as soon as possible. The FDA encouraged pediatric studies from the beginning of the review process, Medtronic says.
Availability status right now is:
- Manufacturing has begun and they are now taking orders for the 530G, but it could be a few weeks before the product is ready to be shipped.
- Both new and existing customers will have immediate access to the 530G, and the company's "Pathway" program will allow some existing customers to get an upgrade -- but details aren't yet finalized.
- Existing customers have already started getting emails about upgrading when the device is available, and Medtronic execs say that on the first morning after the news broke they had 500 calls and their system crashed from the amount of calls. (Lots of interest, apparently!)
- System costs will be "comparable to the Revel"; 530G retails for $7,350 in total, and with insurance, Medtronic expects most patients will likely pay between $500 and $1,200 out of pocket.
- In addition to working with an in-person 530G trainer, those buying or upgrading will also be automatically enrolled in a program that assigns them a specific call center contact for the first 6 months, rather than having to talk with someone new every time they call.
FDA Holdup / Warning Letter
The big question on many a mind in the D-Community is: was it FDA or Medtronic itself that caused this new system to move through the regulatory process like molasses?
Here's the "glossy answer" from corporate execs (via the press release):
"This is a first here in the U.S, and so it's been a challenge for both of us because it's new grounds for the agency and they didn't know what to do with it," said John Mastrototaro, chief technology officer and VP of research, technology and business development for Medtronic Diabetes. "We've had more conversations in the past 12 months than we have during the past several years combined. This is a learning process for all of us in moving forward."
But then the news broke of an FDA warning letter issued to the company on Sept. 19 relating to problems at a manufacturing facility inspected as part of the FDA approval process for this new device. Here's what Medtronic says about that letter, in a statement:
Medtronic has received a warning letter from the U.S. Food and Drug Administration from an inspection conducted February through April 2013 in its Diabetes facility in Northridge, CA, as part of the FDA's review of the PMA for the MiniMed 530G...
The items covered are related to six categories: corrective and preventative action, complaint handling processes, process validation, process monitoring, design control and general good manufacturing processes (GMP).
The warning letter acknowledges the extensive work we have already completed to address many of the observations noted by the FDA. The company will respond with additional steps that will be taken to address any concerns raised as quickly as possible.
Medtronic has put a post-market surveillance program in place, related to the FDA's concerns, that will ensure the company closely monitors consumer feedback on the device.
Aside from that, those watching this device approval process also suspect the FDA was waiting on a key piece of evidence that came out in data presented at the ADA Scientific Sessions in June. That pivotal data was a part of the ASPIRE study, showing that the automatic insulin shut-off cut the rate of nighttime hypoglycemia by 32% and did not cause A1Cs to rise. The study was even able to demonstrate that not a single PWD went above 200 as a result of the insulin shut-off.
Mastrototaro noted that FDA's concerns about the LGS (low-glucose suspend) feature centered on PWDs experiencing higher blood sugars or A1Cs, or possibly even going into diabetic ketoacidosis as a result of the two-hour shut-off. But thankfully, those concerns have been allayed, especially now with the hard science facts coming out of the ASPIRE study.
From the time those results were released in mid-June, it was only a matter of time before the FDA granted approval, Mastrototaro says.
In a conference call on Friday, Medtronic's Vice President of Regulatory Affairs Mark O'Donnell said the FDA has been "very interested in getting this technology approved." He says we PWDs have "many friends in the FDA," and that the agency's very interested in having more patient advocates involved in the device approval process (Editor's note: hooray!). A lot has changed and the FDA is "much more receptive" now than it was just a few years ago, Medtronic says.
"I'm not going to say we were sitting around singing kumbaya together, but the relationship (with FDA) has definitely improved over the past 2-1/2 to 3 years," O'Donnell said.
The Device Pipeline Win
This is the fifth-generation insulin pump Medtronic has created and it comes 30 years after the company's very first insulin pump, the Minimed 502, was released in June 1983. Needless to say, we've come a long way in those three decades, and in just the past decade since Medtronic's first wireless-communicating insulin pump (the 512) hit the market. Medtronic was first way back in April 2006 to bring the first pump-CGM integrated device here to the States, something Animas is just now hoping to follow with its FDA submission of the Animas Vibe on April 15.
What's most exciting about this system is of course the progress it brings toward a fully functioning artificial pancreas system.
Note that the LGS suspend feature only kicks in when you are already low, which is not the same as actually predicting low blood sugars and then stopping insulin delivery in advance to prevent a low, but that's in the works. Mastrototaro tells us the next-gen Medtronic Minimed 640G (6th gen predictive) system would include that advanced feature, called "predictive low-glucose management'." Oh, and the device would actually look different than the long-unchanged look of the Medtronic pumps. We've been told the plan has been to file this predictive 640G for approval over in Europe sometime by the end of 2013 (!), and based on that timeline probably seek U.S. approval in 2015. Same with the Enlite 2 sensor, which offers more advanced technology called "repetitive glucose sensing" and could be filed soon in Europe as well, we're told.
Along with working on future AP technology, Mastrototaro said Medtronic's strategy is to "stagger its release of new products" so that there's something new for patients every year, and a new pump iteration every couple of years. They're "continuing development work on a patch pump concept" and are also busy developing a single-site infusion device for an insulin pump and CGM sensor. But there's no timeline yet on those items, he said.
"I've been in this field for 24 years, and this is the most exciting time in the world of diabetes," Mastrototaro said.
I guess we'd have to agree with that, and we really do think this new device is a key first step toward a whole new era of diabetes control.