Since announcing the news that we received FDA approval of MiniMed® 530G with Enlite on Friday, it’s been great to hear so many of you share in our excitement about this new product and critical first step toward a fully automated artificial pancreas. Hearing from you here on The LOOP as well as on Facebook and Twitter, as always, is really wonderful. In addition to sharing enthusiasm for this new technology, you’ve asked many very good questions. To answer some of these top questions, we’ve invited a very special guest blogger to The LOOP – Mark O’Donnell. As vice president of regulatory affairs here at Medtronic Diabetes, Mark has been instrumental in partnering with the FDA in order to allow us to bring this groundbreaking new technology to the U.S. diabetes community.
Hello LOOP readers. First, thank you so much for sharing your comments and questions with us – whether it’s by giving us a call, talking to your local Medtronic representative or through social media channels. Hearing your stories and excitement for MiniMed 530G reminds me and everyone else at Medtronic the reason we all come to work every day – to improve the lives of people with diabetes. It’s also great to hear your thoughts and concerns. Speaking of which, here are my answers to the most common questions you’ve heard so far.
Q. Can my child (under the age of 16) use the MiniMed 530G system with Enlite? Why not?
A. MiniMed 530G with Enlite is currently not approved for use in children under the age of 16. I can certainly understand how this can be frustrating or confusing for many parents of young children with diabetes. Please know that we are actively pursuing the clinical evidence to support an indication for children 2-15 but can’t provide a timetable for when we’ll have such an indication. In the meantime, I encourage you to talk to your child’s doctor. Like with any aspect of your child’s diabetes care, your physician is the best person to tell you what the best diabetes technology is for your child.
I also want to emphasize that Medtronic is extremely committed to pursuing this clinical evidence. The FDA has already approved two additional studies in children (2-15) to determine the appropriateness of this therapy in children under 16 and the studies will begin enrolling participants soon.
Understandably, this leads us to the next question:
Q. Why weren’t children included in the clinical data Medtronic submitted to the FDA?
A. Our approval for the system was based on a clinical study of people with diabetes above 16 because the study protocol (its design and implementation) was very challenging. Participants were forced into hypoglycemia through exercise and kept there. It was determined that this would not be appropriate for children. The study was an “in-clinic” study, which took place in a controlled setting with the support of a healthcare team.
Now that the product has been approved, we can conduct an “in-home” study that measures the safety and effectiveness of the product as participants use it in “real-world” settings, which is more appropriate for children.
Q. How long have you known about this labeling and its impact on the New Technology Guarantee program?
A. Many of you are familiar with the New Technology Program we started last December. Medtronic customers who purchased a MiniMed Revel insulin pump and CGM during this time were offered a free upgrade to our new technology (the MiniMed 530G) once it became available. We’re working hard to provide the new product and training to these customers age 16 and over as quickly as possible.
However, since the MiniMed 530G system was not approved for children under the age of 16, we are not allowed to promote this device for those children. That means we cannot satisfy and ship the MiniMed 530G under the New Technology Program. I encourage you to talk to your healthcare team about the best option for your child.
I understand this is frustrating and disappointing. However, during the New Technology Guarantee program we didn’t know what the final indications for use was going to be. (We get these final indications for use from the FDA when we get product approval.) While we did know that our study had only involved adults and children 16 and over, we didn’t know for sure what the labeling would be given that the MiniMed Revel system is indicated for children age 7 and older.
Q. How can my child participate in the upcoming clinical studies?
A. This is a great question and one we love to hear. Participating in clinical trials is really valuable to the diabetes community. If it’s something your family is interested in exploring, you can check www.clinicaltrials.gov, which is where the studies will be posted when the trial sites begin enrolling in a few months. The LOOP team also tells me that they’ll post updates here once enrollment has begun.
Q. Why did you call the MiniMed 530G an “artificial pancreas” system?
A. At Medtronic our goal is to develop a fully automated artificial pancreas for people with diabetes – a system that will be designed to automatically deliver the amount of insulin you need with very minimal interaction from you. We are not there yet, even with the MiniMed 530G system. However, the MiniMed 530G system is a critical first step on the journey toward that goal. With Threshold Suspend, it is the first FDA approved device that can stop insulin delivery temporarily if a sensor glucose value reaches a preset low level and the patient doesn’t react to the alarm. This is the first system that takes action based on sensor glucose readings and the first product approved under the FDA’s new category Artificial Pancreas Device System – Threshold Suspend.
This is one of three categories designed by the FDA as types of artificial pancreas device systems. You can read about all three categories here. This is where the language “artificial pancreas device system” comes from.
The fact that the FDA has clearly defined these three categories is great news for the diabetes community, as it gives us a path forward in developing iterative steps toward a fully automated artificial pancreas system. Those iterative steps are important because a fully automated system is not going to arrive suddenly. Our plan is to step-by-step develop innovative technologies with increasing levels of automation in order to advance to our ultimate goal – a fully automated artificial pancreas system.
If you have any additional questions, please feel free to share them in the comments and the LOOP team and I will be happy to answer as much as we can.
IMPORTANT SAFETY INFORMATION
Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components 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 associated with the use of these systems. 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.
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. 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.
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.
Please visit MedtronicDiabetes.com/isi for more details.
, continuous glucose monitoring
, insulin pump
, MiniMed 530G