Medtronic Announces Approval of MiniMed 530G with Enlite

Diabetes Technology Insulin Pumps
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Minimed 530G with Enlite

MINNEAPOLIS – September 27, 2013 –Medtronic, Inc. (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the MiniMed® 530G with Enlite®, a breakthrough, first-generation artificial pancreas system with Threshold Suspend automation for people with diabetes. Medtronic’s system is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn't respond to the Threshold Suspend alarm. The MiniMed 530G system incorporates the new Enlite sensor, Medtronic’s most accurate and comfortable continuous glucose sensor with a 31 percent improvement in overall accuracy from the previous generation.i

“We’re excited to bring yet another important ‘first’ to the United States. The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections,” said Katie Szyman, president of the Diabetes business at Medtronic. “We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market.”

The Enlite sensor delivers better comfort and reliable CGM accuracy. In addition to the 31 percent improvement in overall accuracy, the Enlite sensor detects up to 93 percent of hypoglycemia episodes when predictive and threshold alerts are on.ii The Enlite sensor is also 69 percent smalleriii than the previous Medtronic sensor, to deliver improved comfort in using continuous glucose monitoring. The new Enlite server provides a simpler sensor insertion process with a hidden-introducer needle.

The MiniMed 530G system was approved for use by people with diabetes ages 16 and older. Medtronic will conduct a post-approval study including children ages two and older. The Enlite sensor can be worn for six days.

As a condition of approval, in addition to the post-approval study, Medtronic will engage in direct patient follow up and will make certain manufacturing accommodations. These commitments are consistent with the product approval by the FDA and an accompanying warning letter issued to Medtronic on Sept. 19, 2013. Medtronic has already addressed many of the observations noted in the warning letter and is committed to resolving the remaining observations as quickly as possible and in accordance with the product approval requirements. Medtronic is committed to providing safe and effective products for people with diabetes.

Medtronic will begin ramping up production immediately to prepare for a launch of the MiniMed 530G in the next several weeks. In the meantime, customers can find additional product and important safety information at www.medtronicdiabetes.com.

Artificial Pancreas System with Threshold Suspend Automation
The MiniMed 530G system is the first system approved under the new product classification, “OZO: Artificial Pancreas Device System, Threshold Suspend,” created by the U.S. Food and Drug Administration. Threshold Suspend automation automatically stops the delivery of insulin if glucose levels reach a threshold, which can be set by a healthcare provider between 60-90 mg/dL. Once the threshold is met, the MiniMed 530G system will first alert the wearer with an alarm. If the individual is sleeping, unconscious or otherwise unable to react, the system will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.

When Medtronic develops a next generation product for diabetes control, it will be designed to fully replicate the function of the pancreas by automatically monitoring glucose levels and delivering appropriate insulin to people with Type 1 diabetes; this future "fully automated artificial pancreas" will truly require minimal to no interaction by the patient user.

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This is good news for pumpers and CGMers It should be a big improvement over the 523 plus the CGM is significantly more accurate.

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Shouldn't an artificial pancreas also pump glucogon? It's an insulin pump with an integrated CGM that has an automatic shut off.

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They say that it is a step in the development of the artificial pancreas by having the shut off feature. At this point the auto glucose has a ways to go before it is ready for approval. It looks like it is a much better pump and CGM but as for the automatic

Shut off, I hope it is an option to use or not use. Are you a MM/CGM user?

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The Enlite Sensor has been available in Canada since Spring combined with the Veo pump ; the cost of one sensor is approx CAN $ 65,00 http://www.medtronicdiabetes.ca/en/paradigm_veo.html

Being used to the previous sensor ...already forgot the name, ha, ha ( the large needle never bothered me ) I needed to do a bit of new learning how to attach to my body .I have the low suspend set @ 3.6 ( x 18 ) and may decide to up it a bit to avoid fewer warnings esp during the night . A pumper buddy of mine helped me initially with insertion ; she was trained by her Pump Nurse ( a recent pumper ) . I am able to get another 15-16 hours of sensor use , after the initial 6 days by starting a " new sensor " .The insulin pump itself has not changed

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I have had my pump for just over a year. I called Medtronic and they are letting me trade mine in for $400. I am just waiting for my DR. to write another letter so I can get the newer CGM as well. I am hoping the new CGM is as good as they say and less painful. The current version kinda hurts.

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Since I just purchased a new pump this summer I am in line to get this upgrade for free! I am excited about it but concerned also as when I talked to the Minimed rep last week if I understood correctly the pump will not work without the sensor. That is a scary thought because should my insurance decide not to pay for the sensors I cannot afford them. I am new to the sensor world since July of this year. When they work correctly I love the data it gives me. It has helped me not to have as many swings as I was having. I am hoping that the new sensors will be more accurate. Anyone have the new pump and sensor yet?

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I'm surprised too, at their comment that the pump will not work without the sensor. If that's the case, I will likely never upgrade, and switch to Animas pump instead.
However, maybe they meant the Low glucose suspend feature would not work without a MM sensor.
It's very possible that people would get the MM 530G pump + sensors to start with, and then for various reasons decide to stop using the sensors, so that really needs to be clarified.

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I just got a call from them today. I got my pump back in March 2013 and my CGM back in September 2013 and according to them, it should be completely covered. I had trouble understanding the CSR on the phone (sounded like a 16 year old high school kid and he was talking really fast).

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I just started using the new 530g pump and cgm and I think it is so much better when putting the CGM on you have to press the button where the line is or it will not go in right but other then that it is very easy to use and more accurate so fair.

is any one else on it yet

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I do not think either , that the comment by ky Woman " if I understood correctly the pump will not work without the sensor." is correct .
I( am in Canada ) am trialing a Dexcom G4 since last Thursday on one side of tummy and other side of tummy the Enlite ...several times I had to shut the Medtronic sensor off , because it hit the Low glucose suspend ; finger poke proved I was around 5.6 ( x 18 ) ...another time sensor showed 14.1 ( x 18 ) and BG again was in the " normal range .Dexcom seems much more consistent..I will have to do some soul searching what my next step is ...I do like the idea of one unit only ( medtronic ) compared to the stand alone gadget

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Can you please clarify from the talk above if the pump may be used without the sensor. I am in the upgrade process to the new system but, I would not want to be forced to wear the cgm at all times. Some cycles I give my body a break from the sensor. I called medtronic and they will not answer this question as they just repeat the system is sold as a 'System". I guess they are under contract to only speak of it as a system.

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I too would like to know. I can't imagine that the pump would stop working w/o the sensor though. That would be just product suicide.

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In Canada the " old " models are not available anymore ..ie anyone wanting a Medtronic insulin pump will be supplied a VEO ...I know of people , who are NOT using the Enlite sensors ..biggest reason is cost and not many Insurance companies are paying for them ...and I prefer too a " holiday from Sensor " then I located this http://www.diabetesmine.com/2013/10/keeping-it-real-on-medtronics-530g.html sadly for the USA market ??? USA/Canada score 0-1 :)

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yes the pump can be used with out the sensor the first one I had failed and was wearing the pump with the CGM turned off for about an hour until I got another one from home

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Agreed, no matter what a medtronic rep might let you assume, you don't need to use the CGM part for the pump to work. In fact, unless you plan to use the improved CGM, there is no advantage over the Revel.

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I am moving in the direction of this new 530G.

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I have had the 530G pump and Enlite sensor for 5 days. So far very good results! I have been impressed with the improved accuracy of blood glucose levels versus sensor glucose levels. I really like the smaller sensor (diameter and length) over the previous one. Looking forward to seeing how successful I am with switching tomorrow (day 6) to a new sensor and placing it on my hip versus the abdomen. I have been turning the Threshold Suspend feature on before bedtime and then turn it off when I wake up. My wife really likes that feature!

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So I've been on the pump for about 6 weeks now and the CGM for about 2 weeks. The pump works as normal, same complaints I had with the previous ones. The alarm isn't loud enough, the interface really needs an upgrade (same buttons up and down to scroll through numbers) etc but it works great

The CGM is another story. The first one that I inserted during my training started giving me erratic readings hours after I left training. All through the night it kept saying my sugar levels were <40 and it kept sirening off. The medtronic rep that sat in during my training kept insisting I should turn on the suspend feature but I adamantly refused telling her I won't do so until I'm comfortable with the cgm readings. so I call up Medtronic the next day and tell them and they send me a replacement sensor and want me to send my old one back to them to analyze. In the meanwhile, I use a new sensor from one of the supply boxes and that sensor worked out fine for the whole 6-7 days. I then changed that one out with the one sent as a replacement and it worked fine for 3 days and then the <40 readings started again. The last two nights the siren kept going off. At all times, my sugars were around 100-110. I just got off the phone with them to have them send out another replacement sensor (this things aint cheap!) and he told me that they've been getting a ton of calls complaining about this problem and they're frustrated with the issue. So apparently I'm not the only one.
Overall, I'm not satisfied at all with the CGM so far but I'll let it play out and see if it was just a fluke (probably isn't since tons of other people have been calling in about the same issue).

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Wondering if the same reservoir’s that I use on my older mini end pump will work with this new pump ?