Type 2 Diabetes: Automated Insulin Dosing Device approved by FDA

FDA has approved the first device for automated insulin dosing for Type 2 Diabetes condition.  

This follows expansion of indication of Insulet SmartAdjust technology (an interoperable automated glycemic controller) which is indicated for the management of type 1 diabetes. Now, this Automated insulin dosing technology will be indicated and be available for management of Type 2 Diabetes as well.  

This approval by FDA is based on findings of a clinical trial on use of Insulet SmartAdjust technology by individuals with Type 2 diabetes on insulin therapy. The study found that the technology is safe and improved blood sugar control of the participants. 

Insulet SmartAdjust technology, an interoperable automated glycemic controller is software that automatically adjusts insulin delivery to an individual with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).  

Type 2 diabetes condition in many individuals does not respond well to non-medical management and to treatment with anti-diabetic tablets. Such individuals need to self-administer insulin one or more times a day using injection or an insulin pen or pump to keep their blood sugar level within safe limit. This requires manual frequent checks of their blood sugar levels for best outcome. Automated Insulin Dosing Device will be a sensible option of such individuals that can their improve quality of life.  

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Sources:  

1. FDA news release – FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes. Posted 26 August 2024. Available at https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes  

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