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Automated insulin dosing now extends to type 2 diabetes, streamlining daily management and enhancing glycemic control.
The August 2024 press release by the US-FDA broadcasted the approval of the ‘first-ever’ interoperable automated glycemic controller aimed at improving the health and quality of life for type 2 diabetics aged 18 years and above. Earlier it was indicated for use in children (aged 2 and older) with juvenile diabetes (type 1 diabetes). This glycemic controller adjusts insulin delivery automatically by connecting to an insulin pump and continuous glucose monitor.
Diabetes is a disorder characterized by insufficient production or improper utilization of insulin, the hormone that regulates blood glucose (or sugar) levels. For people with type 2 diabetes, treatment may include medications to boost insulin production or make the body respond better to it, along with a healthy diet and regular exercise. Many patients require insulin therapy (syringes and pumps) to retain safe blood glucose levels. The newly approved technology automates many of these tasks, lessening the burden on the patients.
This approval was based on a clinical study performed across a diverse set of 289 people aged 18 years and more with type 2 diabetes who were on insulin therapy. Investigators used the automated glycemic controller for 13 weeks. Many of these were also on non-insulin diabetes prescriptions like glucagon-like peptide-1 (GLP-1) agonists. The device effectively improved blood sugar control without serious side effects. Some mild to moderate adverse effects included hyperglycemia, skin irritation, and hypoglycemia. The FDA inspected this technology via the 510(k) premarket clearance pathway, confirming its equivalence to existing devices.
FDA News Release
FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes
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