FDA: Continuous Glucose Monitoring Insulin Pump Approved for Pediatric Patients with Diabetes

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The system allows patients and their caregivers to access glucose measurements through their pump or through a mobile app.
The system allows patients and their caregivers to access glucose measurements through their pump or through a mobile app.

The US Food and Drug Administration (FDA) has approved for sale the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System for patients 2 years and older with diabetes, according to a press release from the Animas Corporation at Johnson & Johnson Diabetes Care Companies (JJDCC).1

Integrated with Dexcom G5® Mobile CGM technology, the OneTouch Vibe™ allows patients or their caregivers to access glucose measurements  through either their pump or wirelessly transmits them to the Dexcom G5® mobile app, ensuring that CGM data will be available “wherever it is most convenient for them,” according to the press release. Glucose data can be shared with up to 5 people through the Dexcom Follow app.

 

"People living with diabetes will no longer have to pull out their pump to read their glucose readings. By having constant access to glucose readings on their pump and now their smart devices, the OneTouch Vibe™ Plus will give people with diabetes greater flexibility and discretion," said Brian L. Levy, MD, FACE, chief medical officer of JJDCC and Vice President of Worldwide Clinical Affairs for LifeScan, Inc. 

The OneTouch Vibe™ is the only Dexcom G5® integrated system approved for use in children as young as 2 years of age. The information it provides should not replace information obtained from standard home glucose monitoring devices.

In addition to FDA approval, Johnson & Johnson has received authorization from Health Canada.

Reference

  1. OneTouch Vibe™ Plus Insulin Pump earns FDA approval and Health Canada license and is first pump integrated with the Dexcom G5® mobile continuous glucose monitor [news release]. Chesterbrook, PA: Johnson & Johnson. Published December 20, 2016. Accessed December 20, 2016.
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