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What's New About Enlite: Medtronic's Newest CGM Sensor

By Karrie Hawbaker

Public Relations Manager

Posted:  11/12/2013 9:35 PM

Tags:

Since launching MiniMed 530G with Enlite a few weeks ago, many customers have asked us how Enlite is different from previous sensors. So, we went to Jeff Myers, Product Manager from our CGM team, to give us the scoop. Here’s what hehad to say.

A few years back, Medtronic initiated a research project to get a solid understanding of what you, our customers, are looking for in CGM products. We spoke with healthcare providers and customers across the nation to get a better understanding of the strengths and weaknesses of our glucose sensor, Sof-sensor. Throughout this process, we were able to uncover a group of customer needs that we, in turn, used to translate into product features for our new Enlite sensor.

These new features can be categorized in three key areas: performance, comfort and simpler insertion. Let’s take a closer look at each of them:

Performance: Enlite is our most accurate sensor*[1]

With an important feature like Threshold Suspend in the MiniMed 530G with Enlite system, having a glucose sensor with optimal performance is key. Fortunately, with Enlite, accuracy is in its DNA! To help improve the accuracy and consistency of our glucose sensors, our research and development team made modifications to the sensor’s chemistry so that the Enlite sensor would generate a stronger, more consistent sensor signal. This change also helped increase the glucose sensor’s sensitivity so that it is more responsive to when your glucose changes.

Once we developed Enlite, we studied its accuracy in a randomized clinical trial. This is an important part of evaluating products before they come to market. In that trial, we saw a 31% improvement in overall accuracy compared to the previous Sof-sensor glucose sensor[2].  We also saw a sensor usage life of up to six days so patients could wear their sensor continuously, for a longer period of time.

Comfort: More comfortable, smaller and more flexible

We understand the importance of comfort when customers are wearing a glucose sensor continuously, so the Enlite sensor was designed to provide two forms of comfort. The first has to do with the sensor insertion. To help improve the comfort of inserting glucose sensors we focused on the insertion needle. Enlite sensors feature a smaller needle, approximately 10.5 mm in length, which is 38% smaller than the needle used to insert the Sof-sensor glucose sensor[3]. Additionally, the needle used to insert the Enlite sensor is a 27 gauge at its thinnest point, compared to the 22 gauge for Sof-sensor’s insertion needle (when it comes to gauge, the larger the number, the smaller the needle). When we asked our clinical trial participants what they thought about how comfortable the insertion of Enlite sensor was, 84% agreed that sensor insertion for Enlite was no more painful than a fingerstick test[4].

The second part we focused on is the size of the sensor which, unlike the needle, stays inside your body. Approximately 8.5 mm in length, Enlite is 38% shorter than Sof-Sensor glucose sensors, and features 69% less insertion volume[5]. This means that the Enlite sensor is 1/3 of the size of Sof-sensor. Enlite is also more flexible, allowing the sensor to easily bend and move as your body moves, which can make it more comfortable to wear. When we asked our clinical trial participants, 80% of them agreed they did not feel the sensor underneath their skin[6].

Simpler Insertion: New simple insertion process

One of the things we’ve often heard from our customers is that they wanted the insertion process to be simpler. When it comes to diabetes management, simplicity is key, right? So, we made changes to improve the way you insert the sensor and the device you use for the insertion.

Enlite is inserted into your body at a 90 degree angle, the angle we’ve learned that most people with diabetes prefer (it’s one of the reasons our Quick-set infusion set (link to Quick-set page on store) is so popular). In addition, the Enlite Serter features a new, ergonomic shape that was designed to muffle the sound when inserting a sensor on the body and hide the needle and sensor from view. You actually never see the needle during insertion! The insertion needle remains inside a spring-loaded needle housing which automatically retracts the needle when removed from the sensor base.

The Enlite Serter was so well designed it was the silver award winner in the medical device category of the IDEA program!

To get the most benefit from all these improvements, proper training is key. So as a reminder, before experiencing the Enlite, please attend an in-person training.

Want more information about the new Enlite sensor? Click here to hear from Ashlie who has experienced the improvements of the Enlite sensor.

Have you had a chance to experience Enlite sensor? Tell us about it in the comments section below.

Important Safety Information

MiniMed 530G with Enlite is intended for the delivery of insulin and continuous glucose monitoring for the management of diabetes mellitus by persons 16 years of age or older who require insulin. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy.

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48-72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected.

The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a home glucose meter. A confirmatory fingerstick is required prior to making adjustments to diabetes therapy. MiniMed 530G with Enlite is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s Health Care Provider.

WARNING: The Threshold Suspend feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the MiniMed 530G` System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider. - See more at: http://www.loop-blog.com/blog/A-Thirty-Year-Journey-with-Medtronic#sthash.FT9HzkAQ.dpuf

Comments

Ken McDade

Posted on Thu Nov 14 00:22:03 GMT 2013

What is the ISIG range for the Enlite?

Bruce Lobdell

Posted on Thu Nov 14 02:48:28 GMT 2013

My old pump failed under warranty . It's a shame they would not let me get the new pump

Louis carrico

Posted on Sat Nov 16 12:06:37 GMT 2013

I would like to know how much insulin the reservoir can hold in mini-med 530G..Thanks

Joel

Posted on Sat Nov 16 16:52:36 GMT 2013

Hi Louis, like our Paradigm Revel system, the MiniMed 530G system comes in 2 reservoir sizes, 1.8 mL and 3 mL. Please let me know if you have any more questions!

Naomi

Posted on Sat Nov 16 21:12:40 GMT 2013

Hi Bruce. I’m sorry to hear that, I will have someone from my team reach out to you to discuss any options you might have.

Naomi

Posted on Sat Nov 16 21:14:19 GMT 2013

That’s a great question, Ken. I’d like to connect you with a member from my team to explain the sensor ISIG range to you so we will be in touch with you soon.

Peg

Posted on Tue Dec 03 21:47:40 GMT 2013

I have been a pump + cgm user for many years and am on my 3rd or 4th pump. I do not have insurance that covers the cost of the pumps or the supplies but would be interested in upgrading to the new 530G. Would someone let me know the cost of the new pump as well as the senors and the transmitter?

Thanks

Mary T Smith

Posted on Wed Dec 04 00:25:30 GMT 2013

I signed up to "New Tech Guar Program" quiet a while ago. I have not heard from anyone to date. Iam so anxious to get the new pump 530G because i get alot of low BG while iam sleeping. I got the Revel pump Dec 2012. Can someone please help me?
Thanks. Mary

Joel

Posted on Wed Dec 04 22:16:58 GMT 2013

Hi Peg. Thanks for reaching out. We do offer financial assistance for those who qualify. I will have someone from my team contact you to discuss your options.

Mary, I am happy to look into this for you, and will have a member of my team connect with you. Please know we have quite a number of the New Tech Guarantee upgrades to process, so please bear with us as we work hard to provide new product and training to everyone in the program.

Steve

Posted on Tue Dec 24 20:26:52 GMT 2013

As an active/sports person and public speaker, I had the original CGM sensor loosing its signal to the pump too frequently that I stopped using it. Is there an improvement in the connection, so that, turning you torso and breaking the connection plane has been solved for in this new solution?

Joel

Posted on Tue Dec 24 22:17:36 GMT 2013

Steve, good question and I'm sorry to hear you had problems with our previous sensor. Our CGM team is out of the office for the holidays but let me look in to this and I’ll get back to you as soon as I can. Thanks for your patience.

Rachel

Posted on Sun Dec 29 07:17:38 GMT 2013

This new sensor is a complete nightmare. It wakes me up constantly throughout the night saying I'm low and turning on threshold suspend. When I test, I am not low, most of the times not even close. I calibrate it and it will still beep at me 5-10min later saying I'm low again; it never registers the updated BG I calibrated. I end up turning the sensor off half of the time I wear it, which makes me wonder why I bother. Anyone else experiencing this problem?

Joel

Posted on Thu Jan 02 00:07:00 GMT 2014

Hi Rachel, I am very sorry to hear that you have had a frustrating experience with the new sensor. I will have someone from my team contact you shortly.

Joel

Posted on Thu Jan 02 21:58:50 GMT 2014

Steve, the new MiniMed 530G with Enlite system includes improvements that can positively impact the connection between the transmitter and insulin pump. Keep in mind the Enlite sensor is smaller and it is important to keep the sensor secure to avoid dislodging of the sensor which could impact connectivity.

Dennis

Posted on Sat Jan 11 23:26:24 GMT 2014

The Enlite sensor is a vast upgrade from the soft sensor. But, the usable life of the enlite is a terrible disappointment. I have now used 8 sensors and the average life of good usable information from the sensor to the pump is only about 72 hrs. With the cost of the enlite sensors being about twice of the soft sensors and the life of the enlite being about half of the soft sensors, the 4 fold increase in user costs is very hard to live with.

Joel

Posted on Sat Jan 11 23:38:18 GMT 2014

Hi Dennis. I'm so sorry to hear that you have had a frustrating experience with the Enlite sensor. I will have someone from my team contact you shortly to try to help.

Cathey

Posted on Fri Feb 14 19:54:12 GMT 2014

I will be contacting my rep, but I'm finding the same results as that of Rachel (Dec 2013 post above). After 40 years as a Type 1 & the 530G being my 3rd pump, I was ready for CGM to help level out my bGs. The Enlite is comfortable & not as inconvenient to wear as I thought it might be. However, the sensors transmit my bGs as high (200+) when my Bayer meter shows 99-115. I have been getting no sleep after 3am because my pump begins alarming for a low bG. At the first alert, I crawl out of bed to check my bG, which typically registers about 120, calibrate, & return to bed only to be reawakened with another low bG alarm. Another bG check (AND calibration) only results in another alarm, even a threshold suspend. What is the purpose of a 'calibration' if it doesn't reset the bG readings? I now have turned off threshold suspend & am wondering if CGM (this one, anyway) is even relevant to my management or my 'trends.' Note: I am staying hydrated & keeping my sensor site well away from my infusion site & I calibrate a minimum of 4x per day since the 12-hr recommendation gives completely faulty results.

By the way, SOMEone in R&D should consider engineering the backlight to come on when there is a low bG or threshold suspend alarm. This is ANOTHER source of frustration when trying to respond to the pump in the dead of night.

Joel

Posted on Fri Feb 14 20:44:00 GMT 2014

Cathey, I’m so sorry to hear you that you are experiencing issues with your Enlite sensor. I will have someone from my team contact you shortly to help.

Peter

Posted on Thu Apr 24 02:10:40 GMT 2014

I've had the same experiences as Cathay and Rachel. The CGM is best at ruining your sleep at night, not monitoring your glucose. Mine keeps telling me that my glucose is low, I'm dying and to call 911. My glucose will be 4.0mol/L, yes low but no I'm not dying. My wife wants me to sleep on the coach. I calibrate 2-3x per day. Overall the CGM product is a disappointment.

Joel

Posted on Thu Apr 24 15:33:54 GMT 2014

Peter, I’m sorry to hear you are frustrated with your CGM. For optimal sensor performance, we do recommend calibrating 3 – 4 times a day. I will have someone from my team contact you to see what else we might be able to do to help, too. In the meantime, you may find this helpful: http://www.medtronicdiabetes.com/customer-support/sensors-and-transmitters-support/calibration-sensor. Please let me know if you have any other questions.

Robin

Posted on Mon May 05 00:58:52 GMT 2014

I have not had a full night sleep since wearing the enlite sensor due to "false" low BG alarms. Obviously many of us are having the same problem could you please post some suggestions as to what we can try?

Joel

Posted on Mon May 05 18:14:38 GMT 2014

Hi Robin. I am sorry to hear you’ve been experiencing issues with your sensor alarms. I will have a member from my team contact you to try and help. Please let me know if there’s anything else I can help you with.

Megan

Posted on Fri May 23 19:21:35 GMT 2014

I started the 530G and CGM a few days ago and have some questions/concerns with the CGM. What is the normal range for the "points" to be off? I'm finding I am always 20 or more "points" off when I check, and that could be in either direction. A minimum of a 40 "point" spread is pretty big. I will calibrate and nothing changes. I've been calibrating at least 3 times a day and when my levels are stable (per the graph). Why calibrate when the levels on the sensor don't change? I understand there is a lag time between BG and SG, but shouldn't the numbers be closer, especially when there are stable levels?

Naomi

Posted on Fri May 23 22:41:31 GMT 2014

That’s a great question, Megan. When glucose levels are rising or falling quickly, there may be a larger difference between your BG and SG meter values, such as after meals or taking a bolus of insulin. You may also find this information helpful: http://www.medtronicdiabetes.com/customer-support/sensors-and-transmitters-support/why-sensor-glucose-does-not-equal-blood-glucose. I will have someone from my team connect with you to try and help.

Todd

Posted on Sat Jun 28 15:41:45 GMT 2014

I am going to upgrade my pump soon and have came here to find user opinions. I certainly am glad I did.

I used the previous CGM system and it was terrible. I didn't like having to calibrate all the time. I was hoping to see that the new system is improved. Needless to say I am disappointed by what I've seen here so far.

I want a CGM that actually checks my sugar and does it accurately. The need for 3 to 4 times a day calibration does not make the life of a diabetic easier in which I thought was the goal. Why not make a CGM that doe what the name entails without cumbersome upkeep?

This sensor is like the old one as far as my research has concluded, only worse. Consistent interruptions in sleep for inaccurate reports of glucose levels makes it worse than its predeccaser.

Medtronic please quit grasping at straws and make a device that works as hard for the diabetic as the diabetic does to keep it correct. I have never researched another company for a insulin pump before, but I will now. My health and well being is important to me and I'll be back when I feel your products work and are not betas or experiments. I'm very disappointed because I have always like my Paradigm, but I refuse to be a Guinea Pig while Medtronic figures out how to make a true CGM.

Joel

Posted on Mon Jun 30 21:55:10 GMT 2014

Todd, I’m sorry to hear you are disappointed. We absolutely do care about the people who use our devices and are focused on improving the lives of people with diabetes, which is why we have invested to improve the accuracy and comfort of our sensors, and to advance insulin delivery with Threshold Suspend, an important step toward an artificial pancreas. All CGM systems require BG meter readings in order to generate sensor glucose readings. Calibrations are essential to making sure the glucose sensor maintains its accuracy over time. If I may, I’d like to suggest that you also read the guest blog, My Initial Thoughts on the MiniMed 530G with Enlite - http://www.loop-blog.com/blog/My-Initial-Thoughts-on-the-MiniMed-530G-with-Enlite. You may find this customer’s experience helpful. If I can help you in any other way please do let me know.

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