Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

tslimx2 + Dexcom G6

The tslimx2 / Dexcom G6 combination is an example of a continuous glucose monitoring (CGM) system and an infusion pump, using:  A diagnostic device  An insulin pump  Connected using custom software, which takes the IVD result, applies an algorithm and translates that at the pump interface to make an adjustment of the continuous insulin in respect to the interstitial glucose level. A true ‘hybrid” closed loop system.

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Multifaceted Example

If the labelling for the device requires updating, does the labelling for the drug? ● If the products are based on the same indication(s), then yes .

What will this involve?

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