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Showing posts with label CGM Trial. Show all posts
Showing posts with label CGM Trial. Show all posts

Saturday, September 28, 2013

Minimed 530G Artificial Pancreas. It's All I'm Thinking About.

It really is all I can think about. I called my doctor yesterday afternoon to get the upgrade to the Medtronic Minimed 530G with Enlite Sensor started and they jumped right on it.

The other night I had an occlusion, so I changed my set and bloused for the high even though I had insulin on board. It was clearly not working. But, apparently some of it was. I was asleep and at 1:00 a.m. bolted upright disoriented.

My Dexcom G7 sensor had ended and I didn't want to start a new one while sky high and then falling with a new set. I took my blood glucose and I was 40. I drank a juice. I was still 40. I drank another juice. Still low, so I drank milk and got some toast with peanut butter. I hit 65. Ten minutes later I was 55. I drank more milk and ate cheese. Finally, I began climbing. About 5:00 a.m. I bolused for a 200, which considering how much I ate, was pretty reasonable.

If I had the Minimed 530G (and my sensor was active), none of this would have happened. I actually had any Glucagon laying next to me in bed, just in case all that food wasn't enough and my husband found me unconscious.

So, for those of you that follow me, you know I did the trial for the Enlite Sensor that comes with this shiny new pump. I have lots of posts about the Enlite Continuous Glucose Monitor sensors and the things I LOVE, including this post, so check them out. I was so disappointed not to get the Low Suspend pump, but one a couple people in Austin got it for trail.

One thing I think is weird, and I'd love to hear the engineers talk about their reasoning on this, but why did they change "Low Suspend" on the Veo in available in Europe to "Thresh Suspend?"

"Thresh," is more understandable? Thresh. Ugh. Maybe that was an FDA thing, because it is that stupid. One of my biggest issues with Minimed is their lack of concern regarding user interface. It is at the bottom of their priority list. However, they are kicking out technology that works well and is reliable and on the cutting edge, which means I buy it. I love shiny, but if it isn't the best medical technology my insurance company can buy, I don't want it.

So, I am working on ordering for both my daughter and I before our insurance changes from 90/10 to 80/20. Are you interested in buying this for you or your child?

Friday, September 27, 2013

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!

Saturday, September 1, 2012

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.

Friday, May 11, 2012

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?

Monday, May 7, 2012

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: Headed to Appointment...

..to see if I get the Veo. Stay tuned this afternoon and cross your fingers!

Tuesday, May 1, 2012

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!

Sunday, April 22, 2012

Medtronic Trial: Bayer Contour Next LINK Investigational Meter


I promised details on the investigational Bayer Contour Next LINK Meter provided with my pump for the trial, so here you have it. A picture says a thousand words, so I'm going to take advantage of that. Forgive me, however, for the not-so-great picture quality. I had to use my phone camera today, as the other camera's batteries were dead. FYI - If you click on an image, you can see it in a larger format. You also have the option of clicking through all the image up close.

Bayer Contour Meter has a USB connection for charging and downloading readings,

Results are displayed across the screen first in a big bold font, then it shoots to a smaller font as seen as it sends the results to the pump. Tough shot: Green bar says, "Results Sent."
There is a useful "Notes" screen that includes this and the following image.
Notes also includes "Activity," which isn't pictured
The meter also includes a reminder to recheck your blood sugar. I haven't used this yet, but this is a new feature, so I'm trying it out.
This is the Menu screen.
This is what you see when you select "Trends."
The is an image of the Logbook. The text under this reading has a scrolling, "Sent, High Blood Sugar."
Same scrolling text and amber color for a low. Font is white if reading is normal.
Easy on/off button, which seems like a silly thing to show you, but if you have the One Touch UltraLink, you understand. Just try turning the sucker off without throwing it out the window. Such an incredibly simple thing to make so hard.


Pretty cool! I didn't give it enough credit in my first post, but I also hadn't played with it much at that point. I don't upload the meter into Carelink, all results are sent to the pump, so they are uploaded with the pump info. However, if you needed to upload the meter only, you could. Whatcha think?

Thursday, April 19, 2012

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?

Thursday, April 12, 2012

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?

Tuesday, April 3, 2012

Medtronic Minimed Trial Part two: Got Some Stuff

I had my second visit for the Medtronic Minimed Veo and Enlite Sensor trial on Monday. I was given a new Revel pump and a new meter from Bayer that links to the pump. It has a color screen. It is under investigation as well. I was also given a binder full of papers and log sheets, a blood ketone meter, ketone strips (I have to check every morning. Ugh.).

I will have to upload my readings to CareLink under a trial username each Friday and log my ketones and notes, like the fact that I have a cold right now. Also need to record exercise, lows, etc.

In two weeks I go back and get the Medtronic Minimed Enlite Sensor and can't wait to tell you about it. If you've read my blog long you know how much I hate the harpoon of a sensor they offer now. I like the results, but the UI is sucky.

One bit of info that isn't confirmed, but intriguing is that Minimed intends to continue to use the Revel model, not the Veo, but upgrade the technology in the Revel. Not sure why, but I guess the study is for the technology, not the device itself.

I just want all of this to come to market. I want the Medtronic Sentry for my kid and I want the hippest thing out there to help us manage this pain in the ass disease.

FYI - I am wearing the Dexcom 7 Plus CGM until I get the Enlite. Wearing it makes me remember why I really like the Minimed; it is all in one. I am constantly losing my Dexcom receiver in my bathrobe pocket, in my car, in my jeans that almost made it to the wash. Sigh. Hurry Minimed!

Tuesday, March 27, 2012

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.

Thursday, February 23, 2012

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!

Monday, January 9, 2012

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?

Thursday, March 13, 2008

FreeStyle Navigator FINALLY Approved

Well, the time has finally come! The Abbott Diabetes Care FreeStyle Navigator Continuous Glucose Monitoring System is finally approved by the FDA and available!

I started this blog when I was admitted to a three month study of the Navigator and I wrote extensively about my experiences over the trail. It begins with my first day and continues through some trials and tribulations over the following three months.

I included lots of pictures of the unit, of the insertion process and it seems that it is virtually the same unit I used in trail, but they updated a few irritating things, like there was no way to escape out of the reports window without waiting for it to time out.

During the trail my blood sugars were more manageable, but it was only in my final week of the trial that I truly realized how profoundly this technology could improve my control. My doctor could see things that would never be seen with 8 tests per day. I had a drop in my A1C of 10 percent during the trail and that prompted me to buy the Minimed CGM when it came out with the Minilink.

I think there are comparable in technology, BUT the Navigator would give me alarms 30 minutes before I was low and that saved me more than once. Also, you have readings every minute, which can be very helpful as you are dropping.

The insertion of the sensor is MUCH better with the Navigator and you don't see this HUGE needle plunging into your belly like you do with the Minimed.

The Co-pilot software was awesome; way better than the Minimed version. I loved the visuals along with the numbers.

I could not find the pricing information on the web, so I called the hot line and held for 5 minutes. They took my personal information first, then told me the pricing would be as follows:

The receiver and transmitter kit, which also includes one box of Freestyle strips, batteries and lancets will range in price from $960 -$1040. The Sensor kit includes six sensors for approximately $360-390. That is $60 a piece folks. Not sure how much I appreciate that without insurance coverage.

If anything, I think this will give Minimed and Dexcom a run for their money, which I hope in turn, brings about sexier and more sophisticated devices from which to choose. I like my Minimed because it is contained all in one unit, but if I were to buy today, I would absolutely consider the Navigator.

Monday, June 11, 2007

Reminder: Freestyle Navigator Info in Archives

I was at Camp Bluebonnet today with my daughter and a bunch of great parents and their kids with diabetes and I was reminded of how grateful I am to not only have a CGM, but to have had the experience with the Navigator CGM that is still not released yet. For those of you just tuning in to my blog, and are interested in learning more about the Freestyle Navigator Continuous Glucose Monitor to be released by Abbott Diabetes Care later this year (crossed fingers), I have chronicled three months of trials in the first part of my blog archive.

Keep in mind, that my comments and photos were of a version that isn't necessarily going to be released, and the things that will most likely change are size and calibration times. I love my Minimed Real-Time, but the Navigator was awesome when the CGM projected lows or highs -- really quite accurately. I look forward to the day I can upgrade to the latest technology, but I count my blessings every day I have the sophisticated technology I do have.

There will always be a tomorrow, as with computer technology, but to utilize the best the market currently offers is an awesome experience and My A1C is the better for it. Next steps are to get this and all CGMS covered by insurance, but for now I count my lucky stars...Oh! my blood sugar right now is 138 post dinner.

Friday, March 9, 2007

Adios Freestyle Navigator--May be Avail. Dec. 2007!

I went to return MY Navigator today. I shed a single tear as I ripped the adhesive from my arm, pulling off my last sensor. They downloaded my info and I filled out a very long survey similar to the last one with questions about the trade-off of having a smaller sensor (See my post on January 14, 2007). There wasn’t a comment page, so I said if you want to know what I really think from the perspective of my daily use go the www.diabetesselfcare.blogspot.com. I did manage to squeeze in some notes into an area of the survey that had room for comments about things that had nothing to do with my actual thoughts.

My Endo came in to look over my readings and was shocked at my last week. I was in the green—that’s normal-- almost all the time. He noticed my sharp drops to almost-low post meal and we changed my bolus ratio slightly, but overall I am kicking booty.

I spent a lot of time with the woman who works for Abbott Diabetes and who is responsible for this trial. I sat down and told her what I thought. First, I told her how impressed I am with the Navigator; that this is the best invention since insulin. I described how it saved me from countless lows and in the very last week of the trial I fully realized the power of constant readings—we made such minute adjustments to my bolus wizard and basal rates that I am in really good shape for a while. BUT without checking in with my CDE or Endo on a regular basis, I could not have realized what this information means for my control. I also told her about the issues that I felt needed addressing (also see Jan 11 post).

So what else can I tell you? OH! I think the Navigator may be out before Christmas! She wasn’t specific, other than to say it is probably coming out this year.

Wednesday, March 7, 2007

I went to the doctor and the doctor said...


...I have a bunch of changes to make. This is my last week with the Navigator and I am beginning to get pretty bummed about that. Yesterday I met with my diabetes educator, who hung the moon, and we looked at my blood sugars from the CGM on the CoPilot software. She'd look at day after day of readings and say, "See here, you are dipping a little at 5:00 a.m. and you seem to be rising after lunch each day."

There is NO WAY she could have ever seen those changes without the CGM. We made a new pattern for my week (or two) of hormonal changes after I ovulate (TMI for you guys, but I bet you have hormone fluctuations, too) and we made many adjustments to my basal rates and also to my sensitivity.

I also learned that my older version of the Minimed pump (712) does not have a way to change the duration of the insulin board based upon what kind of insulin you use. It is automatically set to assume that it is hanging in there for eight hours after a bolus, whihc really messes with correwctions post meal. I have seen with the CGM that two hours post meal (where I had a correction with my meal) it says 216. I try to do a correction, but it says 0.0, assuming I have insulin on board that will cover the high. I check again at four hours, still high and says no correction, BUT, the insulin is long gone. SO, now if I see highs four hours after a meal or correction and my sugar hasn't gone down, I will ignore the 0.0 and do the correction.

I would have ever seen the subtly and nuance of my blood sugars and reaction to food without this thing.

Can you hear the woe in my voice? I talk about this CGM like it is a friend who has walked away from me to hang out with the cool kids. Of course, I can just go buy the Minimed version, but I want the smaller sensor; I want second generation technology, not the huge two piece unit. I want one with the kinks worked out. So, I wait and I guess I'm going to have to check my blood sugars more than a couple times a day.
HOWEVER, I have today, Thursday and the morning on Friday to use this tool and work out the kinks of the changes we made. Pretty drastic changes and I am excited to see if they fix my low-highs (low 200s).

Headed to a press conference at 11:00 a.m. at the Texas State Capitol where a very positive stem ell research bill that supports research for degenerative diseases and conditions (that means diabetes) will be announced.

Wednesday, February 28, 2007

I have to give it back...

I got a call from my Endo's office today to remind me of my final appointment related to the CGM study. It is on Friday, March 9 and no, Abbott did not choose to extend the study. Sad, sigh...

I have been running high all week...made adjustments to my basal rate with little effect. It is PMS; hormones make diabetes so difficult! Even with the CGM it is hard to"watch" and evaluate yourself all the time. Definitely more to share on that subject later.

Tuesday, February 27, 2007

Adding Insulin and Food Data into Navigator

I just had a great question from Val about how the insulin and food information is input into the
Navigator, so I thought I'd post some more photos to show you how.











































Next, you have to go back to the main screen as pictured in the second image and select "Meals," then: