FDA Clears First Device to Automatically Dose Insulin for Type 2 Diabetes

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Key Takeaways

  • The FDA has cleared the first device to automatically dose insulin for type 2 diabetes.
  • The Insulet SmartAdjust technology was previously cleared for use in type 1 (childhood onset) diabetes.
  • This means individuals with type 2 diabetes no longer have to rely on manual dosing via a syringe, pen, or pump.

The FDA has approved Insulet SmartAdjust automatic insulin dosing technology for type 2 diabetes in those aged 18 and older.

The interoperable automated glycemic controller software connects to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (ICGM). Together, they automatically adjust insulin delivery to those with diabetes.

Prior to clearance, the FDA reviewed the results of a clinical study of 289 individuals aged 18 and older with type 2 diabetes. All participants were on insulin and used the SmartAdjust technology over a period of 13 weeks.

The study included participants with varying levels of experience with insulin use and diabetes, including those using common diabetes medication such as GLP1 agonists.

The results showed improved blood sugar control compared to before the study, with improvements noted across all demographic groups.

No serious adverse events or complications were noted during the study, with only mild to moderate adverse events reported. These included hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), and skin irritation.

Insulet SmartAdjust Tech Automates Insulin Therapy for Type 2 Diabetes

With over 11% of Americans diagnosed with diabetes, the clearance of this technology for use in patients with type 2 diabetes has the potential to make a huge difference to their lives. 

Up until now, individuals with type 2 diabetes have needed to administer insulin with a syringe, pump, or pen. These options mean patients need to regularly monitor their blood glucose levels alongside administering insulin once or more daily.

The clearance of the Insulet SmartAdjust technology automates these manual tasks, and it’s hoped could make living with type 2 diabetes easier.