FDA Approves t:slim Insulin Pump for Children Ages 6 and Older



The U.S. FDA has approved Tandem Diabetes Care’s t:slim Insulin Pump for use by children age 6 and older. Until now the t:slim Insulin Pump was approved for use by children age 12 and older. This expanded pediatric indication applies to the current t:slim Pump features, with no changes to the existing user interface.

The t:slim Pump is the first and only touchscreen insulin pump cleared by the U.S. Food and Drug Administration. Some of the features of the t:slim Pump that stand out most to parents and younger users include:

       Small Size – The t:slim Pump is smaller than other durable pumps making it easy to wear, yet holds up to 300 units of insulin so it can keep up with a child’s changing insulin needs.

       Durability – The t:slim Pump is made of aluminum, which is extremely durable and light, and the touchscreen is made of high-grade, shatter-resistant glass.  The pump is also watertight, so you don’t have to worry about accidental dunks and splashes.

       Feature Lock – A feature lock can be used for young children not yet ready to operate the pump on their own.  When activated, it can be used to prevent young users from being able to deliver a bolus or change any pump settings.

       Insulin on Board (IOB) Calculations – The t:slim Pump tracks the amount of insulin that is still active in the body from previous boluses and uses this information to calculate future boluses.  This helps prevent “stacking” insulin doses which can cause low blood sugar (hypoglycemia).

       Personal Profiles – Up to six personal profiles can be created with unique names to cover a wide variety of situations, including school days, sleepovers, weekends or sport practice.  

       Missed Meal Bolus Reminder – This reminder can be set up to watch for boluses at specific times of day, and trigger a reminder if no bolus is delivered.  This is especially helpful for children who may forget to bolus when they are away from home, such as during school lunch periods.

       Site Reminder – This reminder is a programmable setting that reminds the user when it is time to change their infusion set.  A specific time and date can be set for the reminder, which can be very useful for busy families on the go.

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