FDA approves long-acting insulin titration system

The FDA has approved Glooko’s Mobile Insulin Dosing System for the titration of long-acting insulin for people with type 2 diabetes, according to a company press release.

The Mobile Insulin Dosing System, or MIDS, is the first insulin titration application accessible through a unified diabetes management platform, which provides a complete program for diabetes management, according to Glooko. The system includes access to a patient’s blood glucose data directly from their glucose meter, allowing people with diabetes to avoid manually entering fasting blood glucose information. Additionally, health care providers can access diabetes data in the MIDS module.

“Managing long-acting insulin can be a challenge for people with diabetes because it requires patients to regularly change their doses based on their own calculations using fasting glucose values. This can be daunting and unreliable,” Michael Greenfield, MD, chief medical officer at Glooko, said in a statement.

“I am excited that Glooko can now offer MIDS, which helps clinicians support their patients in safely and rapidly attaining optimal glycemic levels. In a premarket study, I used MIDS with my patients and was able to witness both improvements in glucose control and how happy patients were to have an easy tool to help them titrate their insulin dose on their mobile phones,” Greenfield said.

MIDS analyzes a patient’s fasting blood glucose levels and recommends insulin dose adjustments based on the health care provider’s preconfigured treatment plan and/or published clinical guidelines, so patients can quickly get to their optimal insulin dose. The system includes customizable in-app reminders to check fasting blood glucose and to take insulin.