US FDA gives clearance to CozMore® Insulin Technology System updates

Monday, 27 Nov, 2006

Smiths Medical announces it has received clearance from the US Food and Drug Administration for new software and features on its CozMore® insulin technology system.

Srini Seshadri, Group Managing Director of Smiths Medical, said: “We are proud to offer new features and programming that will help our customers control their diabetes".

These advances further support our mission to keep the CozMore® system on the leading edge of insulin pump technology.”

The new features expand the personalisation capabilities of the CozMore® system. The CozMore® system includes the Deltec Cozmo® insulin pump, the CoZmanager® PC communications software and the CoZmonitor® blood glucose module.

The following are some of the new features available only through the CozMore® system:

  • Enhanced Meal Maker® carbohydrate calculating feature – A food database that lists carbohydrate amounts to make it easier for customers to track their carbohydrate intake
  • Weekly Schedule – This lets customers programme several settings to occur automatically by the time and day of the week so they don’t have to change settings every day
  • Disconnect feature – A feature that calculates the insulin that would be missed when customers remove the Deltec Cozmo® pump for up to two hours and lets them take part of that missed insulin before and after they disconnect
  • QuickStart™ feature – In one convenient pump menu, customers have a one-stop place to programme the basics of the Deltec Cozmo® insulin pump, which can get their pump therapy started quickly and easily.
  • Hypo Manager™ feature – A feature that recommends the number of carbohydrates a customer should eat to correct a low blood sugar test result, which gets the customer back to a healthier condition.

The majority of these advancements came from suggestions made by our valued customers and the healthcare professionals who recommend and prescribe the CozMore® system,” Mr Seshadri said.

The updates also include a change in Deltec Cozmo® insulin pump colours. The newest Deltec Cozmo® pumps will be available in Tropical Green, Pacific Blue, and Volcano Black. The current colours will be retired.

The updated software and enhancements will initially be sold in the United States and in China.

Diabetes and Insulin Pumps
Insulin is a hormone produced by the pancreas that converts sugar (glucose) into energy that is needed for daily life. In Type 1 diabetes, the body does not produce insulin. In Type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Without insulin, blood sugars rise uncontrollably, endangering the health and life of the person with diabetes.

An insulin pump, like the Deltec Cozmo® pump, provides a steady insulin supply (called basal insulin) throughout the day and night as well as larger doses (or boluses) of insulin to control the sugar, starch, and carbohydrates a person eats. Insulin is delivered through a pump the size of a cell phone and attached to the body with tubing. Although blood glucose tests are still needed, an insulin pump eliminates the need for multiple daily insulin injections for people with diabetes.