Finally: FDA Approves Minimed 530G + Enlite Sensor

The FDA has approved the next generation Minimed 530G insulin pump with low glucose suspend and the more accurate/smaller/less painful Enlite sensor. Years of waiting for this milestone are OVER.

Details can be found in this Medtronic press release.

Can I be first?

Tom- thanks for posting, although I won't be standing in line with you.

I may try a trial elite sensor, but it would have to be significantly improved, and compare better with Dexcom (or exceed it's accuracy/convenience) for me to consider a switch.

I'm also not too keen on the low glucose suspend, since I have a relatively stable basal pattern for overnight, and am awakened by Dexcom alerts when I occasionally go low. But I can see it might be helpful for those with unpredictable nighttime basals, possibly due to active lifestyles, variable activity level/sports, etc. I think many parents are looking forward to it for their kids.

What about the 730G? I take too much insulin for the small reservoir.

Woo Hoo! And relieved. My source told me Aug/Sept and a lot of people refused to believe it because we have heard that before! But can't wait to get the Enlites!

The Enlite needle is the same size as the Dexcom and easier to insert. We recently had the opportunity to try the Dexcom as part of the Artificial Pancreas trial. My daughter had to wear two Dex g4's at the same time. I was expecting perfection because Dex users constantly swear the product is leagues above MM. Well, the two Dex's were usually off by at least 10 from each other and often 50 or more off from the meter. The doctors in the trial said within 20 in considered in range...well, then we have had better accuracy with the MM. And what is probably the most important thing about the 530 pump is the low suspend..whether you use it or not. Because that single feature is the significant step toward having an Artificial Pancreas approved in the near future. The FDA fought long and hard against the low suspend....but you cannot have an Artificial Pancreas without having the closed-loop system. Hooray for the first step!

I read several weeks ago in a Medtronic conference call that the release was expected in Q4. One thing about figuring out when new products will come out is to avoid the diabetes online community (with all the rumors/hopes/dreams that circulate) and go with the financial press. They have rules and laws that control what company leaders can and cannot say. That and they are simultaneously trying to spread good news to attract new investors means that it gives an important and informed glimpse about when new products will actually come to market.

The 530G/Enlite is not perfect for everyone (obviously) but for folks like me with highly unpredictable Type 1 coupled with gastroparesis & hypoglycemia unawareness, this next generation system is a long awaited step forward.

Worth reading also is a study on the NIH website discussing a comparison of the Enlite and Sof-Sensor.

Yeah--now to figure out how to get one. Love the suspend feature--even after adjusting to low insulin at night, I still have terrible lows.

I just received an email from Medtronic on this too..says since I am in the "New Technology Guarantee Program" I will be contacted in next couple of months to receive this new system and training. Makes for a happy Friday!!

That is good news. I replaced my out of warranty 523 late last year and was promised a replacement pump as soon as this pump was approved. I cannot wait!

When I read that comparison it sounds like the enlite is LESS accurate - I hope that's not true!
The overall median sensor-reference difference was -15 mg/dL for the Enlite and -1 mg/dL for the Sof-Sensor (P<0.001). The median relative absolute difference was 15% for the Enlite versus 12% for the Sof-Sensor (P=0.06); 66% of Enlite values and 73% of Sof-Sensor values met International Organization for Standardization criteria. Isn't that saying that the Enlite values were OK 66% of the time while the sof sensor was 73% of the time?
That's not making me happy.
Please tell me I am reading that wrong!

Does anyone actually have ay experience with how the low suspend works? I switched back to DexCom and MDI because when I was using the 722 and prior generation MM CGMS, the accuracy was not there for me - I had a seizure in my sleep with BG in the 20s post-glucagon and the MM unit said I was never below 85 (and I had it fail to detect severe hypo more than once), so even if it's more accurate now, I would love it if I could set it simply not to deliver basal insulin if I am below 90 or something. (Still want to bolus for meals at 75, but don't need basal insulin at 75...)


Nope. Thats how I read it. Lipstick on a pig. Looks like hiding the needle of the inserter is the big improvement.

Only one study. Maybe there is other evidence of improved performance. We can only hope.

Has anyone started getting the Minimed 530G either through the New Technology Guarantee Program or the trade in program???

Just got my training on the 530g last night. Am wearing the enlite sensor right now.

Can't say anything about the accuracy yet, but it is easier to insert, and so far, more comfortable to wear. The new sensor has a taping solution included with it that looks like it might hold it on more securely.

Aside from the threshold suspend feature, the pump itself is essentially a 723 Revel.

Got my last Friday and go for training on Monday.

Can you insert the cgm in leg or arm?

I have a question, for those fortunate Canadians and Europeans who have been using the Enlite sensor;
Was it compatible with the 723? Any special tricks to be aware of?
I like the concept of the CGM, but the sensor seems to be the one weak link.

Check out these discussion regarding US users getting their first Enlites. Timothy reports success using them with his Revel.

Enlite discussion link

upgrade advice link