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notme

MiniMed® 530G with Enlite®

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Medtronic, Inc., 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.

 

Medtronic Inc. - Press Release

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I'm excited to hear the sensor is 31 percent more accurate. I wonder how this compares to the Dexcom. I'm also disappointed that minimed has the same pump. I thought they would have moved to a touch screen device, but then we are dealing with the FDA and If I remember right Medtronic submitted this pump to the FDA a couple years ago.

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If I hear the sensor really is more accurate and comfy from folks who actually use it, I might be interested. When I used the CGM previously, I was very disappointed. And it would be good to see a side by side comparison to Dexcom.

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Interesting to try. I am one month shy from 4 year on my 723 now. Their store still shows the older model of sensor... :)

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The pump is exactly the same as the vibe which has been used for the last couple of years in Europe. Not everyone is that complimentary about the sensor accuracy so do be warned.

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Actually, it is the same as the VEO, which has been available for several years in Europe. The VIBE (also only available in Europe) is an Animas pump which interfaces wirelessly to the Dexcom G4 sensor system.

 

The Enlites have also been available for some time. Consensus seems to be that they are certainly more comfortable and seem to be more accurate than the Sof Sensors. However, consensus also seems to be that the Dexcom G4 is better still now that it has a pump to link to. I am due a new pump and am considering switching to the Animas VIBE to take advantage of the longer life and better accuracy of the Dexcom sensors.

 

Joel

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Actually, it is the same as the VEO, which has been available for several years in Europe. The VIBE (also only available in Europe) is an Animas pump which interfaces wirelessly to the Dexcom G4 sensor system.

 

The Enlites have also been available for some time. Consensus seems to be that they are certainly more comfortable and seem to be more accurate than the Sof Sensors. However, consensus also seems to be that the Dexcom G4 is better still now that it has a pump to link to. I am due a new pump and am considering switching to the Animas VIBE to take advantage of the longer life and better accuracy of the Dexcom sensors.

 

Joel

 

Sorry my mistake should have said VEO not VIBE.

I have an animas pump and am not impressed with it. It's feels as if I have gone back in time compared to the Cozmo. I would advise you to double check the cost of replacement parts with the Vibe, as the transmitter part has to be replaced every 6 mths So if you are self funding that could be pricey.

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Sorry my mistake should have said VEO not VIBE.

I have an animas pump and am not impressed with it. It's feels as if I have gone back in time compared to the Cozmo. I would advise you to double check the cost of replacement parts with the Vibe, as the transmitter part has to be replaced every 6 mths So if you are self funding that could be pricey.

 

Sue:

 

Thanks for the advice. If I were simply considering the pump (on its own) I would stick with Medtronic. Despite the limitations of the screen (think old-style Nokia mobile phone) I am used to the the menu systems and it is pretty reliable.

 

However, I have been trying to calculate the cost of using the sensors and it seems like the Dexcom will work out significantly cheaper (see my calculations below), not to mention the likely superior performance (more accurate, shorter lag time).

 

G4 sensors cost £50 each (=US$80) but from what I can find out (from talking to a number of users) last on average between 14 and around 20 days (a few people even longer). That makes an average of around 18 days. The transmitter costs £250 and lasts on average around 9 months. Enlite sensors cost £52.50 each but feedback from users suggests they last on average around 8 days only. The transmitter costs £375 and lasts on average around 2 years.

 

If we now do the sums based on the above life expectancies the annual expected costs are:

 

Dexcom G4 £1346

Enlite £2582

 

One of the limitations on the life of the Enlites is the requirement to remove the transmitter and re-charge it after 7 days. This works fine with the old Sof-sensors (provided you do this carefully) but the Enlites are much more delicate and tend to fail if you do this. The Dexcom transmitter cannot be re-charged (which limits its lifetime) but this means it can be left in situ when re-starting a sensor.

 

Given the cost savings it seems like I am going to have to switch to Animas as I can't see the point of going down the route of a separate receiver for the Dexcom.

 

Joel

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Hi Joel, thanks for taking the time to do all the costing and letting me know the result. I've been considering CGM for quite a while so was wondering whether to hope and pray my 2020 broke so had a replacement Vibe sent out or invest in the new navigator11 which came out August time I think.

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It truely is hard to compare costs of CGMS. Warranties are just guaranteers on the manufacturer replacing it. Does your car break down at 5 years/100k miles and quit working? No. It's just replacement is costly to you and it's up to you if you replace it. However, like a car, you need to replace the oil at regular intervals (determined by you and how your car reacts) to prevent damage.

 

With pumps the 4 year warrant on the pump is just a guideline. I have an Animas 1200 in my cabinet at home that is 8 years old, 4 years out of warranty, and it still works like the day I got it. Can I use it? Why not? Now, the infusion sets, my body says 3.5 days max. When I first started I could go 5 days. I know people that only get 2 days. It's your body, find out what your body likes. And then you can calculate costs from there.

 

It's the same with CGMS. The new Dexcom transmitter has half the warranty of the original. I'm on month 10 with mine that went out of warranty 4 months ago. My original Dexcom 7 transmitter lasted over 3 years...warranty, 1 year. Never replaced it. HUGE cost savings to me. How long the sensors last is also a huge factor one has to think about. Very hard to calculate that aspect as it also changes often enough with regards to them making minor changes in manufacturing.

 

My two cents, costs are all generally about the same when you factor in the long run.

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Hi Joel, thanks for taking the time to do all the costing and letting me know the result. I've been considering CGM for quite a while so was wondering whether to hope and pray my 2020 broke so had a replacement Vibe sent out or invest in the new navigator11 which came out August time I think.

 

Sue:

 

I am glad my calculations are useful. I did the maths myself because switching pumps is a major step and I only want to do so if there are signficant advantages in using the Dexcom CGM system. I am actually quite happy with the Medtronic pump, I can work it with my eyes closed or in the dark without thinking. Also, my clinic has started people on around 150 pumps and all of them have been Medtronic. I suspect I may encounter some resistance if I ask for an Animas as a replacement. I haven't heard much about the Navigator. From reading the internet discussions and talking to users, the overwhelming consensus seems to be that the Dexcom system performs better than Medtronic/Enlite.

 

I don't know about Animas, but with Medtronic, if your pump conks out under warranty they replace it with the same model. My 522 crashed with a motor error about 3 years ago and they sent me another 522, even though the model had been superseded by the Veo. Of course if your 2020 dies, you might be able to "persuade" Animas to upgrade to a VIBE if you are going to be buying expensive sensors.

 

I have been using Sof-Sensors for the past 3.5 years on a 24/7 basis. Otained through the "grey market" at knock down prices - don't ask! Unfortunately the sources have dried up (or rather been suppressed) so I have to go legit. There is no way I would go back to the old days of relying solely on fingersticks. Knowing your BG at any time and more importantly knowing the trend just makes life SO MUCH EASIER! I usually only need to do around 5 fingersticks per day, I can get away with eating mysterious stuff and guessing the carb count - if it starts to go wrong, I can see the trend within an hour or so of a meal and either correct or treat accordingly. AND I can go to bed knowing that if I stat to drop I will get an alarm!

 

JediSkpdogg:

 

Thanks for the info. It's useful to know that the transmitters last longer than the minimum 6 months. I ran my first Medtronic minilink transmitter for nearly 3 years, but there is less of an issue with battery life since you have to recharge every 7 days. As far as the warranty is concerned, my present pump is now well over a year past its warranty date and apart from a crack in the case, works well. The main advantage of a warranty is the promise of a fast replacement if it fails. TBH, pump manufacturers tend to be excellent in shipping out replacements even for out-of-warranty pumps b/c they expect an order for a new one.

 

Joel

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What pump does the Dexcom G4 link to?

I believe they are working with tandem diabetes care, t-slim pump.

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What pump does the Dexcom G4 link to?

 

Animas Vibe, which isn't available in the USA. Vibe was first used in the UK about 2 years ago.

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currently have animas and my pump is out of warranty this month. the 530G looks good with the Enlite. I could use a sensor monitor to help with my weird levels but don't know if this price will be right?

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currently have animas and my pump is out of warranty this month. the 530G looks good with the Enlite. I could use a sensor monitor to help with my weird levels but don't know if this price will be right?

 

The 530G is (as far as I can tell) identical to the VEO which has been available in Europe for over 4 years. The VEO differs from the Revel in the following:

1. It will shut down the CGM sensor after 6 days use rather than 3 (even before introduction of the Enlites, the Sof-Sensors were certified for 6 days use in Europe)

2. It features a low BG basal suspend option. This halts basal delivery for a period if the sensor indicates that glucose levels are below 2.8 mmol/L (50 mg.dl).

 

Teh low glucose suspend feature is very useful for children (who may be too young or unable to respond to anaudible alarm during the night) or for someone with severe overnight hypos (requiring emergency intervention). For most of us the audible/bibrate alarm is sufficent warning to allow us to deal with an overnight hypo. I know a few VEO/CGMS users - I don't think any of them use the low-glucose suspend. The new 640G which is undergoing pre-release trials will supposedly feature a predictive low glucose suspend which is a real move towards the artificial pancreas. This model should be released late 2013 or early 2014 in Europe but is unlikely to appear in the US for several years.

 

If you are a current Animas user and due for a new pump, you might try to make some enquiries to see if there are plans to release the VIBE in the US. This links to the Dexcom G4 VGM system. It does not feature a low glucose suspend, but as per my comments above, you may not want this anyway.

 

Joel

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I attended my Diabetes support group meeting last night. The leader is a Medtronic trainer. She advised that although the Enlite sensors have not been approved to work with the older transmitters, she was told in private that the do indeed work with the old transmitters. Accordingly, she recommended that we Sof-Sensor transmitter users should order the new Enlite sensors to take advantage of the improved accuracy. However, We should not expect the 31% improvement because that improvement was based on the combination of the Enlite with the new transmitter. There will be improvement, especially at the lower BG readings where the Sof-Sensors apparently lost accuracy.

 

She also recommended that those who are currently under warranty, still have a working transmitter and are opting for the Path 2 System to not order the Enlite Starter Kit (Extra cost) until the old transmitters need to be replaced.

 

Although the Enlite Sensors last 6 days, the old transmitter fills up its memory in 6.5 days so that if you want to extend the life of the Enlite, you will need to recharge (cleans out memory) the old transmitter.

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Don:

 

The Enlites use the exact same Minilink transmitter as the Sof-sensor!! It is identical. I know of several CGM users on this side of the pond who switched to the Enlites - they continued with the same transmitter. So when the Medtronic trainer advised you that you would not see the full advantage of the Enlite if you used the old transmitter, this was incorrect.

 

The minilink transmitter has a 7 day timeout. This is the same regardless of which sensors or which pump you are using. To restart you have to remove and recharge the transmitter. The older x22 pumps and the US Revel pumps will timeout the sensor after 3 days. The VEO (Europe) and the 530G (US, the same as the VEO) will time-out the sensors after 6 days. This is a separate timeout to the transmitter.

 

The differences between the US and Europe stem from difference in the regulatory framework. In the US, even quite small improvements/changes to the technology require a full assessment. Europe, incremental improvements to the technology do not require a full assessment. For example, around 4 years ago Medtronic improved the Sof-sensor life enough to allow them to offer 6 day use. In the US this would have involved going through a full FDA assessment, so the same sensors were certified for 6 days use in Europe but remained at 3 days in the US.

 

The problem is if you force manufacturers to go through extensive and time-consuming procedures for every minor improvement you just discourage progress.

 

Joel

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Thanks, Joel, for the correction. I checked with the Medtronic trainer and she confirmed that the improved accuracy is with the combined Enlite sensor and the new 530G pump (not the transmitter) which has an improved logarithm system to calculate the BG information.

 

However, I am on a Revel pump and it does alow 6 plus days before it times out the transmitter.

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