US-based device company Luna Diabetes has initiated a pivotal trial evaluating its automated closed-loop insulin technology, the Luna System, in patients with type 1 diabetes (T1D) who require multiple daily insulin injections.
The Luna system was developed as a wearable insulin pump and alternative to insulin pen to automate the insulin delivery process. The device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep.
The AID4MDI trial (NCT06627517) will enrol up to 130 participants with T1D. The study aims to evaluate whether the study device is safe and if it reduces blood sugar levels in people who have consistently high blood sugar during sleep and at wake. The trial's primary endpoint is time in range, defined as the amount of time a person with diabetes spends in a target glucose range of 70mg/dl-180mg/dl.
The trial will also measure the number of events of severe hypoglycaemia and diabetic ketoacidosis, as well as severe and life-threatening complications of diabetes. Luna Diabetes expects the study to be completed early next year, with plans to commercially launch the device “soon after”.
The diabetes care market is expected to grow to be worth $33.5bn in 2030, as per the GlobalData market model. This growth will be mostly driven by insulin delivery devices, with these devices market is forecasted to generate $25.6bn in 2030.
Although insulin pumps are not a new invention, there have been advancements to decrease the device’s size and increase its efficacy. Multiple companies have used machine learning and AI algorithms to optimise insulin delivery.
In November 2023, DexCom, ViCentra and Diabeloop launched a small hybrid closed-loop system to deliver insulin. The device has a built-in DBLG1 algorithm that can receive information from the Dexcom G6 CGM device. The system can reduce the incidence of hypoglycaemia by more than 50% using real-time data.
Despite multiple advancements, the area has also suffered setbacks. Earlier this month, the US Food and Drug Administration issued a Class I tag to Medtronic’s recall of its MiniMed insulin pumps after the manufacturer noticed battery life issues. The recall affected MiniMed 600 series and 700 series pump systems.
