CGM software authorized, infusion sets recalled, tirzepatide approved for obesity
The FDA cleared a software system that works with continuous glucose monitors (CGMs) and insulin pumps for marketing and announced the recall of some lots of insulin infusion sets.
Among multiple recent actions related to diabetes, the FDA cleared Control-IQ Technology for marketing on Nov. 3. The software is intended for use with compatible integrated continuous glucose monitors and alternate controller-enabled insulin pumps for the management of type 1 diabetes. Together, these devices can automatically increase, decrease, and suspend delivery of basal insulin based on glucose readings and predicted glucose values.
The agency also announced a class I recall of VariSoft infusion sets on Nov. 27. The sets, manufactured by Unomedical A/S, are being recalled due to damage to the connector piece causing unexpected disconnections that could lead to hyperglycemia if not detected and reconnected promptly. One injury has been reported. The sets are used with Tandem insulin pumps, and the recall includes the following lots: 5388367, 5388357, 5388371, 5388362, 5388368, 5388366, 5388372, and 5388376.
The FDA also approved a new indication for tirzepatide (Zepbound) to be used for chronic weight management in adults with obesity or overweight and at least one weight-related condition. The dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist injection should be used in conjunction with a reduced calorie diet and increased physical activity. Tirzepatide is already approved for type 2 diabetes.