MiniMed is racing against other diabetes tech companies like Insulet and Tandem Diabetes Care to develop automated insulin delivery systems that don’t require meal announcements or carb counting.
After taking a look at the competition during the American Diabetes Association meeting, Ali Dianaty, MiniMed’s chief product and technology officer, believes his team has the lead.
“From what we can tell, especially based off of hearing from everybody else's results and feedback at ADA, we're clearly ahead right now,” Dianaty said in an interview after the ADA’s Scientific Sessions. “We just need to finish the trial and be able to show that to everybody else as well.”
MiniMed is about halfway to enrollment of a pivotal trial of the technology, CEO Que Dallara said in an earnings call earlier this month.
Based on that enrollment progress, early data shared by other companies, and the fact that MiniMed is making an algorithm that can be used by people with Type 1 diabetes, not just Type 2, Dianaty believes MiniMed is ahead of the competition.
Automated insulin delivery, or AID, systems use a glucose sensor and insulin pump in tandem to ensure people with diabetes get the insulin they need. However, with most systems today, people still need to count carbohydrates and take a bolus insulin dose ahead of a meal.
MiniMed and other companies are working on a version of this technology that they call “fully closed loop” systems. The devices would remove the need for carb counting and meal announcements, although they don’t automate everything about managing diabetes. MiniMed’s new algorithm would remove the need for pre-meal insulin doses, although users would still have the option to bolus if they choose.
MiniMed, in a poster at ADA, explained how it developed and validated the algorithm. It was designed using a simulator with about 20,000 virtual patients, across diverse demographics and real life scenarios. The company tested the algorithm in actual patients across two three-week periods of fully announced meals and unannounced meals. The participants had an average time in range of 82% when they announced meals and about 74% when they did not. The measurement tracks how much time during the day a person stays within a target blood glucose range.
Abbott partnership
Dianaty also shared updates on an expanded partnership with Abbott, which will involve Abbott making a dual glucose-ketone sensor exclusively for MiniMed. Abbott received Europe’s CE mark for the dual analyte technology in late May. Abbott also makes a continuous glucose monitor, called Instinct, for MiniMed.
Dianaty said the companies plan to launch the dual-analyte sensor in such a way that glucose and ketone data would all be in MiniMed’s app. He sees value in tracking ketone levels to help prevent diabetic ketoacidosis, a life threatening condition caused by severe insulin deficiency. Certain medications, such as GLP-1 agonists, can also cause a rise in ketone levels.
“Ultimately, when we take a step back here, there's still a lot of data to collect and understand with ketones and how people interact with it,” Dianaty said.
