The US Food and Drug Administration has approved a new stand-alone continuous glucose monitoring (CGM) system, Medtronic's Guardian Connect, that alerts users to impending high and low blood glucose levels up to an hour in advance.
The device is approved for people with diabetes aged 14 to 75 years and targeted at those using multiple daily insulin injections. The Guardian 3 sensor is the same one used in Medtronic's so-called artificial pancreas, the MiniMed 670G, a hybrid closed-loop CGM system, which accurately alerts patients of 98.5% of hypoglycemic events, according to a company statement.
Guardian Connect does not have a receiver and will be the first CGM to launch in the United States that has smartphone display as the only option for viewing data.
The device sends CGM data directly to the smartphone app.
Another app, Sugar.IQ, made through a partnership with Watson, will pull CGM data from the Guardian Connect and combine it with additional information, a Medtronic spokesperson told Medscape Medical News.
Sugar.IQ will be exclusive to Guardian Connect users, meaning even MiniMed 670G as well as non-Medtronic CGM users will not have access to the IBM Watson-powered app at launch.
"With artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how an individual's glucose levels respond to their food intake, insulin dosages, daily routines, and other factors. Together with the Guardian Connect system, the Sugar.IQ assistant can turn difficult-to-determine patterns into personalized, actionable insights," according to the Medtronic press release that details the approval.
As with other CGMs, the new device reports blood glucose readings every 5 minutes. But unlike the others, the Guardian Connect allows users to customize alerts to notify them up to 60 minutes before they reach personal pre-set low or high glucose values.
And similar to the Dexcom share function, Guardian Connect allows caregivers to track the user's glucose levels remotely in real-time or via text alerts.
However, similar to the Dexcom but unlike Abbot's Freestyle Libre, Guardian Connect requires twice-daily fingerstick calibration.
And, unlike both the Dexcom G5 and Libre, Guardian Connect retains an adjunctive indication, meaning that patients are advised to perform fingerstick confirmations prior to pre-meal or correction insulin doses.
The Guardian Connect system will be available between May and July 2018.
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Cite this: FDA Approves New 'Smart' Continuous Glucose Monitor for Diabetes - Medscape - Mar 13, 2018.