7. Drug & Device Updates

FDA Approves Guardian™ Connect CGM System

The FDA has approved Guardian™ Connect continuous glucose monitoring system for use among people with diabetes using multiple daily insulin injections and aged 14 to 75 years. It is the first smart standalone CGM system that does not require a receiver and directly sends continuous sensor glucose data from the sensor transmitter to a smartphone. The Sugar.IQ™ smart diabetes assistant app with artificial intelligence technology from IBM Watson Health, continually analyzes how an individual's glucose levels respond to their food intake, insulin dosages, daily routines, and other factors. Like other CGMs, the Guardian™ Connect CGM reports glucose readings every 5 minutes. The system has customizable alerts that allow the users to get notified about future high and low glucose events up to 60 minutes in advance, and also allows the caregivers to track the user's glycaemic status remotely in real-time or via text alerts. It uses Guardian Sensor 3, the latest and most advanced sensor which is FDA approved to be used to control the Artificial Pancreas system, MiniMed™ 670G hybrid closed-loop insulin delivery system.

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FDA Clearance for Glooko Insulin Dosing System for Type 2 Diabetes

The US FDA has cleared the Glooko Mobile Insulin Dosing System (MIDS) for the titration of long-acting (basal) insulin for the treatment of type 2 diabetes. The system, housed within a mobile app, helps healthcare providers create customized treatment plans including insulin titration rules that they then "push" to the patient. The system includes access to the blood glucose data directly from the patient’s glucose meter which eliminates the need for manual entry, and healthcare providers access accurate diabetes data in the MIDS module. MIDS analyzes the fasting glucose levels and recommends insulin dose adjustments based on the healthcare provider’s pre-configured treatment plan and/or clinical practice guidelines so that patients can quickly and easily get to their optimal insulin dose. The MIDS app also reminds patients to check their fasting glucose levels and to take their insulin. The system is not, however, intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

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