Tests for New Diabetic System

Medtronic’s www.medtronic.com “MiniMed 670G” system is currently FDA approved in the U.S for people with type 1 diabetes that are 14 years of age or older. Medtronic has just announced that new data obtained from their at-home pediatric study examining the use of the MiniMed 670G in patients 7- 13 presented at the “Advanced Technologies & Treatments for Diabetes International Conference” in Austria, has shown positive results.

Smart Guard sensor technology is Medtronic’s proprietary algorithm that powers its advanced MiniMed insulin pump systems. Developing a closed loop system provides more automation for the SmartGuard technology thereby enabling the system to do more of the work associated with daily diabetes management.

The MiniMed 670G system features the company’s new Guardian Sensor 3, which is the most advanced SmartGuard Auto Mode algorithm. This sensor allows the system to automate the delivery of basal insulin throughout the 24 hour cycle.

However, Medtronic’s MiniMed 670G system is currently used only for people with type 1 diabetes 14 years and older. The company wants the system to be used for children below 14 and include children 7-13 years of age, since the study on children in this age range shows positive results.

The at-home multi-center study enrolled 105 participants ages 7-13 and included a two week run-in phase followed by a three month study phase. Over 15,353 patient days were included in the evaluation with 97 percent of participants opting to continue using the system as part of a continued access program.

Medtronic is also evaluating the use of the MiniMed 670G system in children 2-6 years of age and will present data from this trial at a future time. Product labeling currently warns that the system may not be safe for children under age 7 or patients using less than 8 units of insulin per day.

“The data shows that the MiniMed 670G system can lead to more time in the desired glucose target range in school-aged children while it reduces both time spent in hypoglycemia and hyperglycemia”, said Francine Kaufman M.D Chief Medical Officer of the Diabetes Group at Medtronic.