Medtronic Minimed 530G Low Glucose Suspend and Enlite FDA APPROVED!

Just announced!  

Medtronic Gains Approval of First Artificial Pancreas Device System with Threshold Suspend Automation

Read more here!

This is what we have been waiting for! Read about what I experienced in my trial of the Enlite CGM Sensors that come with the pump. It is SO much better than the sensors offered now. I did not have the low glucose suspend pump, but I can't wait to have that for my daughter and I!

More later!

Medtronic Survey of New Pump Style Options

So, I got an email from Medtronic Minimed yesterday to take a survey. It was supposed to take 25 minutes, so I as hesitant, but decided to go ahead and do it on my smart phone. I couldn't believe my eyes and I am SO mad I didn't take the survey on my desktop so I could capture some screen shots, a task I have yet to figure out or need on my phone. Anyway, the survey was comparing four different styles/functions of pump/Continuous Glucose Monitor (CGM).

There were technically two styles, but one offered artificial-like pancreas functions and one was just a pump with no CGM options, which just seemed weird. They both offered color screens on a remote control to manage pump/CGM functions. One was a rectangle about 1 1/2" x 2 1/2". It sat on a baseplate infusion set and had a "pump" with 200u of insulin inside. This affixed to your skin directly via the base plate infusion set. You had options to bolus from the pump directly, but there as no screen, so probably just an audible system. This would come in handy if you left the remote at home and were out.

The second style was a 2" round disc. It also had an infusion set that went with it and looked like the ones now, but the disc was a pump that held 300u of insulin. The pump could also be affixed directly to your skin or you could clip it to your belt, put it in your pocket and maybe your bra. It had no function for bolusing on the pump, but shared the remote shown with the other one.

The biggie deal here was when selecting which ones you liked best, it was clear they were trying to see if you were really interested in a CGM based artificial pancreas, because the questions said the pump would cease insulin delivery if blood sugar dropped below determined levels, or would correct for high blood sugars if it went above certain levels. The options given were one step beyond the Minimed 530G, the American version of the Veo.

So, while anxious to just get the 530G and the Enlite Sensors, this is exciting stuff. I was really confused why they would ask if I preferred a pump with a CGM that could shut off or auto bolus vs. a pump with nothing but a remote. Dude. That is so Omnipod!

Bayer's Contour Next LINK Meter Now Medtronic Standard

Looks like Medtronic is moving from the One Touch Ultralink to the Bayer Contour Next LINK I used in the trial! According to medGadget, it will now be the Medtronic standard, even shipping all of us the new meter. I want to thank Gene Ostrovsky for linking to my blog post on my meter use during the trial!

As I mentioned in my post, I liked the meter. It was a nice change from the boring, no-frills Ultralink, but I have about a million One Touch strips to use up. I'm trying to be patient, but it isn't the meter I want, its the Enlite Sensors. Happy for the new meter, but let's hope it is the next step before releasing the Enlite!

medGadget posts meter benefits as:

• Enables fast and easy bolus dosing and continuous glucose monitoring calibration
• Pass-through feature allows for easy downloading to Medtronic’s convenient online CareLINK software, replacing the CareLINK USB device
• Bayer’s No Coding™ technology makes testing easy by automatically setting the correct code each time a test strip is inserted
• Easy-to-read display with large, clear numbers (my favorite feature and the only thing "new" enough to matter)
  
• Fast 5-second countdown and small 0.6 μL blood sample
• Optional pre- and post-meal markers with audible reminders

This isn't a revolutionary product, but it is much more pretty and readable!

Here is the news release from Medtronic, posted on Tu Diabetes by Emily Coles.

Medtronic Enlite Trial: Over and All I Got Was Deep Longing!

The Medtronic Minimed Enlite Sensor Trial was great, but I am truly missing the whole set up. I did have a few sensors I found tucked in a suit case after my trip and have tried to insert them manually, but it is HARD to do it well. So I lost one, feeling like an idiot, and am wearing one now. I've had it on for 9 days. Shhh! Don't tell anyone.

I am wearing them with my old transmitter and when I say old, I mean old. Like 2009, old. But it works well, I just have to restart the thing after three days (I'm back on my pump that doesn't know they new sensors work for six days without restart). At the end of day six, I unplugged the transmitter and charged it, then plugged it back in a started over. Seems to be working very well.

To wrap up my thoughts about the Enlite Sensor:

1. It is simple and painless to insert with the serter. Harder, but not impossible manually.

2. Six days works great and I am certain you could try for more, but that would be a personal choice because this would only be approved for six day use.

3. The accuracy is spot on. Seriously. The variance I see with my harpoon sensors can swing, not wildly, but with more frequency. This Enlite is accurate with very minimal issues. I did have some, but they were temporary and fixed with calibration. One time I had to End the Sensor and restart, but I think that was somewhat a user error issue.

4. I want it for me. I want it for my 12 year old daughter. I want the MySentry for both of us. I want it now.

I can't understand what takes so long. This product has been available for three, going on four years, in Europe. New pumps are being released by small companies with better looks and cooler UI, but I want this. It isn't fancy looking, but it works. We can blame the FDA, but I blame Medtronic for not starting all this sooner. They move much too slow and the FDA brings progress to a trickle.

I am optimistic. The time is passing the same as ever, but I have worn this CGM since April with few breaks and I now rely on it to keep me safe. I can be a mom, focus on my child's care and not worry about myself. If there is a problem, it will be and I love the beeps are minimal.

Medtronic Trial: Enlite Sensor Questions

Still a little bummed I didn't get the Minimed Veo, but I've been thinking more and more about the Enlite Continuous Glucose Monitor Sensor and what it's introduction might mean.

Well, it would mean freedom from harpoons, but really, technologically, it would mean a pump upgrade. Rumor has it they would use the Revel in the US, not the official Veo from Europe, but that wouldn't mean we get to keep our current Revel model.

The current Revel's are programed for the Minilink CGM with a sensor life of three days. The Enlite is six days.

Also, I wonder if they will upgrade the transmitter technology. I'm not thinking so, because I still have issues with weak signals on my trial version. I really need a new transmitter for my personal system, but I don't think I want to upgrade until all of this stuff comes out.

While I totally appreciate the trail on the Veo, and I want it bad, I more than anything want the Enlite sensors for me and my 11 year old. However, I just bet the next major upgrade offered is a combo of a new "Revel" (with Low Glucose Suspend) and the Enlite together. I guess I initially had this thought that I could just order new sensors when they came out, and maybe a new transmitter for extra juice, but that is pretty wishful thinking.

I have amazing insurance (my husband works part-time for UPS and coverage is KILLER), so I'm actually not worried about cost, but this might mean we have to wait for both to be FDA approved, which scares me. I'm eternally sick of waiting on the FDA for new technology. Oh! So weary!

Will you upgrade if a new pump and new sensor system comes out as a packaged deal?

Medtronic Trial: No Veo

Coincidentally, my headline, "No Veo," or "I don't see," in Spanish, is true. My number wasn't drawn in the randomized trial for the Minimed Veo Low Glucose Suspend Insulin Pump. So, no new pump today. Apparently, very few people in Austin got their number drawn in this national study. Boo hoo!

However, I will continue with the Enlite Continuous Glucose Monitor (CGM) sensors and the Bayer Next Link  for another 13 weeks! YAY! I really love the Enlite.

I really would love your questions. I take a lot for granted and may not be telling you everything you want to know. I have a really busy week coming up, so if you post some questions you might have, I'll get answers to you before my next full post. Thanks for all your support!

Medtronic Trial: Upload Complete! Now the Wait. Veo or No Veo?

Today I uploaded my pump for the trial folks to analyze and see whether I am able to continue and be put in the random selection for the Veo Pump with Low Glucose Suspend. If my Carelink log meets some mysterious criteria, my number goes in a hat. If I am picked, I go Monday, May 7 to get trained on the Veo.

Either way, I will continue with the trial, but I may only be testing the Enlite CGM with a Revel pump and not the Veo. I hope to make the trial, mostly so I can tell you all about it! Cross your fingers for me!

Medtronic Trial: Minimed Enlite Sensor ROCKS! So Tiny and Comfortable!

How do I love thee, Minimed Enlite Trail Sensor? Let me count the ways...

Seriously folks, I love this sensor. I've had it on since Monday and I have had some hard diabetes days. I'll get to that in another post, but so far, I can't feel a thing and it works like a charm.

I'm not going to go into how to put it on, because all of that is in a video on the Medtronic website.

Some things I love about the sensor:

• 69% reduction in size compared to previous sensor. We are talking a HUGE difference in size, which meant a HUGE difference in needle required to plunge the thing in your body.
• Adhesive tab that holds the Minilink Transmitter in place.
• Specially designed adhesive that slips over the sensor head before you put on the Minilink. Although, it is super soft and easily gets stuck together, so you have to be quick and hold it on all sides.
• Can't feel a thing. Going in, or wearing it. Nothing. Completely comfortable.
• Six days of wear.

Some things I love about the Serter (although I think that is a silly name):

• Hidden needle.
• Easy enough to load, but requires thought.
• Needle retracts after insertion and you don't have enormous needles to dispose.
• I like that you press the button to unlock the sensor, then let go of the button to release the needle and sensor. Don't know why this matters, but it feels less scary that pressing the button and waiting for the scary click. I only have done this once in the trial office, so I'll fill you in on my next experience.

Other than those things above, it works just like the previous sensor on the pump. Same requirements for calibration, but they are recommending we calibrate multiple (as many as four) times per day, but only two are required for wear. Another thing, I think I can get this on my daughter! Really, this is huge.

Do you wear the Medtronic CGM now? What do you love most and what are your biggest beefs?

Medtronic Trial: End of Second Week

So, I am ending the second week of the pretrial where I am just wearing the Medtronic Minimed Revel with no sensor and no Veo trial pump. I just have to be sure to check my blood sugar four times a day with the Bayer meter mentioned in my previous post, my ketones each day and log everything into a trial version of Carelink each Friday.

Monday I get the Enlite Sensor. I'll try to take some photos to share. Really thrilled about this and the easier to insert sensors.

FYI - Diabetes Daily has asked me to guest blog about the trial, so I will post a link to that next week.

Curious if any of you have tried or even seen the MySentry yet? I would really like to know how this works, especially for parents with T1 kids. Do you want one as much as I do?

First Visit: Minimed Veo and Enlite Sensor Study

Well, I passed all my screening questions for the Medtronic Minimed VEO and Enlite Sensor study. They asked me 4,000 questions that all ended with the answer, "No." They drew three tubes of blood and then gave me 47g worth of carbohydrates in the form of one and a smidgen of a bottle of chocolate Boost. Then I had to wait two hours.

I thought I was free to read or something, but then came out a stack of paper, seriously 2 1/2 inches thick, with a bunch of yellow sticky notes. It was my entire medical history! She went through every single sticky noted page asking if I was on this medication anymore or that, when my knee surgery happened, etc. Lordy, I'm glad I'm not sickly, because this took almost an hour!

Interestingly, the majority of our conversation was around why I don't take my cholesterol medicine. The answer, "I forget" over about six years was not amusing to her. She said, "Part of eligibility of this study is compliance with its protocol." I replied, "It's the pill popping I have trouble with. I can check my blood sugar regularly."

Anyway, I will go into more detail about the requirements of the study, but oh! Joy! No confidentiality agreement, other than their obligation to protect mine. So I will write with Revel (get it?).

My next visit will start with the results of my blood work, which are measuring kidney function. If I am okey dokey, I will be trained and outfitted with a Revel pump, which I already wear. I kinda begged not to have to sit through two hours of training on a pump I own. She said she would see what she can do.

Then I have to comply with study protocol, which includes four BG checks per day and probably downloading into a guest Carelink account and uploading my pump info. If I comply, they will give me the Minimed Enlite Sensor and watch me for a couple weeks. I think I then get my name thrown in a hat and I will be randomly selected for either the VEO with the Enlite or the Revel with the Enlite Sensor. In my mind, I win either way, but I hope I get the VEO pump.

Have you ever participated in a trial? Let me know what you tried and if you blogged about it.

Participating in Medtronic Minimed VEO and Enlite CGM SensorTrial

Yippee! I am going to participate in a four to five month trial that may put me on the Medtronic Minimed VEO, which has been available in Europe. The thing that makes me most giddy is the opportunity to try the new Continuous Glucose Sensors, called Enlite. YAY!

The Enlite CGM Sensor can be worn for 6 days and has a much different profile in terms of the size of the insertion needle and the inserter. YAY!

The VEO offers a Low Glucose Suspend (LGS) feature to halt insulin delivery when the CGM senses you are low. Both devices are long overdue to the American Market, so if I can help speed this sucker to market, SIGN ME UP!

I want this technology for me, but mostly I want it for my daughter. She is 11 now and middle school is so trying for a T1 kid. I can't hold her hand anymore, so I'd love it if the technology would give her more support.

I'll post more after my first appointment. Of course, there are lots of hurdles to qualifying, so cross your fingers for me!

Medtronic Minimed MySentry $2,400!

I just got off the phone with Minimed and was pretty surprised to find the newly announced Minimed MySentry costs $2,400 and is not covered by insurance. It is cool, but I think I am more surprised by the lack of insurance coverage than the price. Hmm. Not surprised, but disappointed. Do you know what would have been smart, to annouce the upcoming release with the price, so we could get the sucker budgeted into our flexible spending accounts. The year just started and I've already ordered $500 in diabetes related supplies. There is no way I can forgo $2400 of my yearly allotment to buy this through flexible spending, but I might have budgeted for it in October. Shame!

I would love to have this thing, except I will never get the existing Minimed CGM on my daughter. I am so glad they are working on new products, but they REALLY need to fix the harpoon.

Really, what I need is an app that will read my daughters CGM or even her blood glucose meter and I will get alerts from it or be able to check on her when she is away.

Medtronic makes good products and really are industry leaders, but I am so incredibly sick of waiting for upgrades and better technology.

It is painful to wait for Medtronic Minimed to move and the MySentry product is a huge advancement (that I was promised five or six years ago), but they need to pick up the pace.

Oh! my goodness it is painful to wait. I swear the blood glucose monitors are exactly the same as I had in 1983, except 40 percent smaller and 40 seconds faster. Painful!

What are you waiting to see?