Medical Device Link.

Originally Published IVD Technology September 2003

INDUSTRY NEWS

Richard Park

FDA has granted marketing clearance to the first device for diabetics that integrates a blood glucose meter and an insulin pump with a dose calculator into one device. According to industry observers, this new device could be the first step toward developing a fully automated glucose-monitoring and insulin-delivery system.

The device is a wireless system that combines the Paradigm 512 insulin pump by Medtronic MiniMed Inc. (Northridge, CA) with the Paradigm Link blood glucose monitor by Becton, Dickinson and Co. (BD; Franklin Lakes, NJ) and facilitates data interchange between the two components.

This integrated system is able to conduct two important steps in diabetes management: blood glucose monitoring and insulin dosing. Using wireless technology, the glucose monitor component automatically transmits a blood sugar reading to the insulin pump part. The pump’s dose calculator then recommends the proper insulin dosage based upon information presented by the patient.

“The power of glucose monitoring and the benefits of insulin pump therapy are now combined in a patient-friendly system that can simplify and improve diabetes management,” said Kevin Seifer, president of BD Consumer Healthcare.

Some industry analysts believe a clear trend is emerging in diabetes management toward increasing integration of monitoring and therapy, as well as providing the technology and tools to empower diabetics to manage and improve their therapy while still enjoying a flexible and varied lifestyle. Analysts also believe this integrated system represents a significant step on the road to an automated pancreas, a fully automated closed-loop insulin control system.

“The automated transfer of glucose readings to the insulin pump minimizes a significant source of user error,” says Mark S. Vreeke, PhD, a principal at Rational Systems LLC (Houston). “The calculation of insulin dosing by the pump is also beneficial in that it further removes and minimizes the possibility for incorrect dosing.

However, does this device revolutionize glucose monitoring? Absolutely not. This product offering is an incremental step that slightly reduces the cycle time for diabetics to control their glucose.

“At the same time, though, one can see where this product is moving. An algorithm that factors carbohydrate intake, glucose level, insulin sensitivity, and previous insulin dosages is essential for realizing the holy grail of continuous glucose monitoring and the artificial pancreas. The continuous monitor can only be realized when the human factor is taken out of the decision loop and insulin injections are automatically controlled by the glucose measurements.”

Copyright ©2003 IVD Technology