Why the Medtronic 530G is NOT an Artificial Pancreas

by Leighann on October 4, 2013

I always say that every pump has its positives and negatives. You have to sit down and make a list of pros and cons about all of the pumps on the market. You need to decide which features are important to you and your child. What is right for one family isn’t necessarily the best choice for someone else. There is no right or wrong answer.

When we began researching pumps, we made the best decision for our family. It was the right decision. Is the pump 100% awesome 100% of the time? No. It’s not. But for us, it’s certainly better than the alternatives.

I just want to be up front that I am not a spokesperson for any insulin pump or continuous glucose monitor manufacturer. In the past year, I did write for Insulet’s Suite D blog and plan to continue writing for them. And I have been to Medtronic headquarters a couple of times. I am not paid to write about these products on this website. And I’m so honest sometimes (like my face to face conversation with the higher ups at Medtronic) that sometimes I’m surprised that they still talk to me. But hey, I give them honest feedback.

So I have some opinions about Medtronic’s new pump/CGM. But my opinions aren’t about whether or not it’s a good pump or a good choice for you or your child. I have a few things to say about the FDA and why we should be asking for more.

Artifical Pancreas Device System

(Image source: FDA website)

Artificial Pancreas Threshold Suspend Terminology

So, here’s where I’m going to insert some opinions. I have to say I was really irritated when I started seeing posts early in the morning about the approval of this “artificial pancreas.” (I may also refer to it as the AP or bionic pancreas.)

This is NOT an artificial pancreas.

But lots of parents on Facebook were either confused or were jumping for joy because they didn’t know the AP was going to get approval so quickly.

This might be the first step to the artificial pancreas, but it is not the full artificial pancreas!

There are currently many clinical trials underway in adults and children working toward the development and approval of a fully functioning artificial, or bionic, pancreas. This is a “closed loop” system meaning that, in simple terms, the insulin pump and continuous glucose monitor talk to each other and make decisions based on complex algorithms. The system will be made up of an insulin pump, a CGM, and a way to give glucagon. One of the issues is creating a stable form on glucagon that doesn’t have to be replaced every 24 hours.

In the full bionic pancreas insulin will be given when blood sugars begin to rise and glucagon will be given when blood sugars drop and/or basal insulin will be reduced/suspended. You (or your child) will not have to count carbs or enter in blood sugars for boluses.

(Also, this video about “inhaled insulin” to supplement the AP is interesting.)

So if the Medtronic 530G isn’t a full artificial pancreas device system why is Medtronic calling it an artificial pancreas?

Because they can.

As part of the approval process, the FDA created the artificial pancreas device system (APDS) category:

“The FDA is helping advance the development of an artificial pancreas device system (APDS)—an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.

FDA’s efforts include prioritizing the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums, and finding ways to shorten study and review time.

FDA’s release of Final Guidance for Industry and the Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems will help provide clarity for manufacturers, investigators and reviewers in the development of this important technology. It allows manufacturers and researchers to be innovative and flexible in how they develop studies. It also promotes greater communication between the FDA and manufacturers and researchers, which will support the rapid, safe and effective development of an APDS.”

Here are the types of APDS’s (from the FDA’s website):

Threshold Suspend Device System

The goal of a threshold suspend device system is to help reduce the severity or reverse a dangerous drop in blood glucose level (hypoglycemia) by temporarily suspending insulin delivery when the glucose level falls to or approaches a low glucose threshold. These are sometimes referred to as “low glucose suspend systems.”

This kind of system serves as a potential back-up when a patient is unable to respond to a hypoglycemic event. Patients using this system will still need to be active partners in managing their blood glucose levels by periodically checking their blood glucose levels and by giving themselves insulin or eating.

Control-to-Range (CTR) System

A CTR system reduces the likelihood of a hypoglycemic event or a hyperglycemic event (when blood glucose is dangerously high) by adjusting insulin dosing only if a person’s glucose level approaches the low or high glucose thresholds. Patients using this system will still need to check blood glucose levels and give themselves insulin to maintain control of glucose levels.

Control-to-Target (CTT) System

A CTT system sets target glucose levels and tries to achieve these levels at all times. This system is fully automated and requires no interaction from the user (except for calibration of the continuous glucose monitoring system).

CTR and CTT System Subtypes are dependent upon the drug or drugs being delivered and how each drug affects glucose levels. Three subtypes are being investigated: insulin-only, bi-hormonal and hybrid:

An insulin-only system achieves a target glucose level by increasing or decreasing the amount of insulin infused.

A bi-hormonal control system achieves a target glucose level by using two algorithms to instruct an infusion pump to deliver two different hormones – one hormone (insulin) to lower glucose levels and another (such as glucagon) to increase blood glucose levels. The bi-hormonal system mimics the glucose-regulating function of a healthy pancreas more closely than an insulin-only system.

A hybrid system allows the patient to supplement insulin automatically prior to a meal. This pre-meal supplement decreases the risk of hyperglycemia after eating.

Yes, technically the Medtronic 530G is considered an artificial pancreas because it is approved for use by the FDA under this category, but it is only the very first step. The “closed loop” is the final product.

The Medtronic 530G does one thing now that other existing products on the market do not do: it shuts off basal insulin delivery if the low threshold has been reached and the alarm is not responded to. Nothing more.

Your child still has to check blood sugars throughout the day.

Your child still has to count carbs.

Your child still has to treat lows.

Your child still has to treat highs.

Your child still has to compensate for activity.

Your child still needs constant care.

It’s not a game changer.

I know you now think I’m a Negative Nelly. Of course it’s great that the first milestone on the way to an FDA-approved artificial pancreas has been reached. But, like I’ve said, it’s a first step. There’s no reason to throw a party. And there’s certainly no reason to stop funding research!

Here’s what I will say: Kudos to Medtronic for finally getting this technology approved in the US. (It’s been available overseas for some time.) If I had a child who was already using the Medtronic insulin pump and CGM, of course I would consider upgrading to this new device.

As I understand it, the CGM is still going to alarm and you are still going to have to react to it. The low threshold suspend only kicks in if you don’t respond. Parents are still going to be getting up in the night to give juice boxes to treat lows. Turning off basal doesn’t instantly bring up blood sugars.

Yes, it is a safety feature that will hopefully make some parents sleep easier.

But I demand more.

What do we want?!

A fully functioning closed loop artificial pancreas device system!

When do we want it?!

Before our kids go to college!

So here’s my issue, what if the general public, those who contribute to the JDRF and other groups funding AP research and trials, stop giving because the “artificial pancreas” is already on the market.

There are already news stories about this revolutionary new device with headlines that make you think that the full artificial pancreas is available and will be in the hands of people with diabetes soon.

Like this one: Petersburg woman first in Indiana to get artificial pancreas


(E-mail and feed subscribers click over for embedded video.)

As if there aren’t already enough misconceptions out there about diabetes. When people read headlines and hear stories like this one, they will assume that managing diabetes just got a whole lot easier. It hasn’t.

What do you think? (About any of this: calling this an artificial pancreas, the new pump or sensors, etc.)

And Another Thing…

More posts about insulin pumps

More posts about low glucose suspend

More posts about the artificial (or bionic) pancreas

More posts about the Food and Drug Administration (FDA)

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{ 13 comments… read them below or add one }

1 Theresa October 4, 2013 at 10:48 pm

Actually, there is reason to throw a party. Automatic suspend is HUGE. Other sensible countries have had this and similar devices approved for a while now. Let’s celebrate this small victory and ask for more from the FDA. The technology is there- in every one of your reader’s favorite companies. We needed this first step to get it going for everyone- and to someday add glucagon to the mix. Hooray!

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2 Robert October 24, 2013 at 3:56 pm
3 Marjorie October 5, 2013 at 8:56 am

Its not just “oversees” that’s had this technology. Canada has had it for awhile too. My daughter has been using the Veo since February, and the CGM since June. We held off until the Enlite was approved.
I certainly value your opinion, and have looked to your blog and book several times. However, I don’t understand your disappointment over the announcement and release in the US. Everything that I have read from Medtronic specifically stated that it was the first step to an artificial pancreas, and that it is. Until you have experienced that low threshold suspend, you can’t truly appreciate it. I’ve had it shut off in the middle of the night because in my bleery-eyed stupor after being up several times throughout the night, I missed one alarm. The pump shut off. I nearly freaked when I walked into that room when I heard an alarm and it had the ” I have diabetes please get help” warning message up, and saw that it had been shut off for 45 minutes.

Yes, everyone needs to know that this isn’t a fully closed system, and what its limitations are.

However, it is an amazing tool, a wonderful first step, and should be celebrated.

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4 Karen October 5, 2013 at 9:30 am

Better, yes, but I’m with you…we want more! And, yes, BEFoRe our kids go to college!!

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5 Julie Fitzwater October 26, 2013 at 10:51 pm

I absolutely agree. It’s bad enough being blown off because people equate type I was type II. They think if we just exercise more and ate right, we wouldn’t need insulin. The pump I have now shuts off after five hours if it isn’t touched. The alarm goes off even if my blood sugar is trending well it doesn’t even have to be low so there’s plenty of warning. The only thing interesting about the new one, is that the sensor might be more accurate and the needle isn’t such a harpoon.

This is a far cry from an artificial pancreas, and I am also afraid that people will think that this is a cure and figure that we are done. I hear you loud and clear. This IS NOT, an artificial pancreas. Thank you!

Julie (type I for 36 years)

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6 Kathy November 6, 2013 at 5:58 am

I object to the use of the name artificial pancreas. It sounds too real. Call it a mechanical pancreas and that would be a more accurate description. You would never visualize a mechanical organ as a suitable replacement.

I like to compare this type of progress as perfecting Pinocchio.
We want to be the real boy (or girl).

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7 Greg December 22, 2013 at 2:17 pm

Medtronic doesn’t identify the 530g as an artificial pancreas per we. Their site states its a breakthrough in artificial pancreas technology. Which seems to be an accurate statement. I think people are seeing what they want and hope to see. I’ve been a type 1 for 26 years and have been a participant in the DCCT/EDIC landmark study for the past 24 years. We all want a cure or something as close as possible. I’ve heard many say “In 5-10 years….”. That was 20 years ago. I want a cure as bad as anyone else but I keep things real and don’t read into anything. The 530g is “the next step closer” to the artificial pancreas.

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8 Leighann December 22, 2013 at 6:53 pm

Actually, in their press releases they threw around the term “artificial pancreas” a lot. Just because the FDA said that it is one of the steps in the artificial pancreas system technology, Medtronic took advantage of that, in my opinion, and used the term more freely than I think they should have. The result was A LOT of media saying that the “artificial pancreas” received FDA approval.

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9 Pete April 5, 2014 at 1:19 am

Did anyone actually read the press release? No where did it say this was a fully functional artificial pancreas. They explained very clearly what this first generation artificial pancreas technology does. There was absolutely no deception.

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10 Leighann April 14, 2014 at 8:18 am

Thanks for commenting.

They may not have said “fully functioning” in their press releases, but they did use the term “artificial pancreas.” They have since backed off use of the term, perhaps because so many people thought that they were being creative with the use of the term.

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11 Suzanne December 31, 2013 at 2:38 pm

I agree this is not a true artificial pancreas !!
They made is sound like wow , there is a cure
This is far from one I would consider a cure
Now instead of one pump attached to me I have another the sensor. Lovely !
I still need to check BS , count carbs , bolus etc etc
I have been diabetic type 1 for 42 yrs yes progress has been made over the years but to call this an artificial pancreas is a lie

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12 Mike Barton January 6, 2014 at 12:12 pm

As you are not supposed to even treat lows with basal suspend/auto-suspend it’s a nice feature but not a game-changer for most. It takes 15-30 minutes for no basal to affect BG. So there goes the rule of 15. (Of course those who sleep alone or through alarms are sure to welcome this.)

The idea that an FDA classification of products has given the company the right to advertise it as an artificial pancreas is just wrong. It is false advertising and poor judgment by Medtronic for the diabetes community — but a good one for its bottom line, clearly used to create buzz and boost share price.

The other big bummer here is no Enlite/530G for under-16s per FDA. What a joke the FDA has become. This product has been available and proven safe for years in countries including Australia. My goodness.

All that said, I am working to get my 11-year-old son on this pump/CGM system because it is an incremental improvement. One blah reason to upgrade — he needs a bigger reservoir. And on CGM, he has Dexcom G4 but having to carry a second (CGM) meter is cramping his style and one too many things to remember, so he ends up not using it. The auto-suspend IS a bonus that I think could come in handy for a sleepover or something.

Welcomed but no game-changer. Get real FDA and Medtronic!

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13 Leighann January 6, 2014 at 12:22 pm

Thanks for your comment!

The FDA approves a device for ages based on the trials that the company submits for their product. Medtronic hasn’t completed their pediatric trials yet and only submitted it for over 16. Since they can supply it to children with a prescription (off-label use), there’s probably no real hurry.

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