FDA keurt MiniMed 530g ®-systeem met Enlite ® goed: eerste generatie kunstmatige alvleesklier systeem voor mensen met diabetes
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De Enlite sensor zorgt voor een beter comfort en betrouwbare CGM nauwkeurigheid die kritisch is voor de prestaties van een kunstmatige alvleesklier systeem. Naast de verbetering van 31% van de totale opname, Enlite detecteert tot 93% van hypoglykemie episodes bij voorspellende en drempel signaleringen op. (Iii)
(rest productinformatie in het Engels)
Benefits of the MiniMed 530G system with Enlite include:
• Automatically stops insulin delivery when sensor glucose values reach a preset low level
• Provides better glucose control compared to multiple daily injections(iv)
• Better detection of low and high glucose values(v)
• Improved sensor accuracy
• More comfortable, smaller sensor(vi) that is 38% shorter in length
• Longer sensor life- Enlite can be worn for six days of use
• Easier insertion with the new Enlite serter that includes a hidden introducer needle and a one button insertion process
Artificial Pancreas System with Threshold Suspend Automation
The approval of the MiniMed 530G system is the key first step of Medtronic’s path to accelerate the development and availability of a safe and effective artificial pancreas. Our goal is to one day develop an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with type 1 diabetes requiring minimal or no interaction.
Threshold Suspend automation automatically stops the delivery of insulin if glucose levels reach or go below a threshold, which can be set by a healthcare provider between 60-90 mg/DL. Once the threshold is met, the MiniMed® 530G system will first alarm. If the individual is sleeping, unconscious or otherwise unable to react, the system will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.
We’ll begin shipping the MiniMed 530G system in a few weeks. In the meantime, to learn more or place an order, visit www.medtronicdiabetes.com.
We are so thrilled, once again, to bring you an exciting and important “first” in diabetes technology and can’t wait to hear what you think so be sure to tell us in the comments!
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.
(i) – Approved by the FDA in the U.S.
– U.S. Enlite Clinical Study Customer Satisfaction Survey. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
– Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin
pump therapy: a randomized controlled trial. Diabetologia. 2012;55:3155-3162.
– Data on File , Medtronic.
(ii) – According to the MiniMed Paradigm REAL-Time Revel User Guide, MiniMed 530G User Guide, and Enlite® Sensor Performance
Clinical Appendix.
(iii) – Enlite® Sensor Performance Clinical Appendix. When calibrating 3-4 times a day and predictive and low alerts both turned on. There
are times the system will falsely alert (alerts when the blood glucose level is above the alert setting.)
(iv) – Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N
Engl J Med 2010;363:311–320.
(v) – with 81% of hypoglycemic events detected. Data on file.
(vi) – The Enlite Sensor is a significantly smaller sensor compared to Medtronic’s previous product –69% smaller in sensor size by
volume, 38% shorter in length. Data on file.
– See more at: http://www.loop-blog.com/blog/Introducing-the-MiniMed-530G-with-Enlite#sthash.A5iYZbik.dpuf
