What's new about Enlite: Medtronic's newest CGM sensor

Since launching MiniMed^TM 530G with Enlite, 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^TM 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. 

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.