The FDA has approved Glooko‘s mobile insulin dosing system, which is designed to titrate long-acting insulin for people with Type II diabetes.
The company’s system accesses blood glucose data directly from the user’s glucose meter so that the user doesn’t have to manually enter their fasting glucose values. Then, it analyzes those levels to recommend insulin dose adjustments based on a healthcare provider’s treatment plan and published clinical guidelines.
Glooko’s MIDS also features in-app reminders for users to check their fasting blood glucose and to take insulin.
“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,” Dr. Michael Greenfield, Glooko’s chief medical officer, said in prepared remarks.
“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 pre-market 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.”
The Mountain View, Calif.-based company said it spent 18 months collaborating with clinical experts to get MIDS ready to hit the market. Glooko has reportedly done a number of user experience design reviews, human factor studies and pre-market programs in preparation for MIDS’ launch.