As Medtronic continues to await FDA clearance of the latest iteration of its MiniMed insulin pump, the Medtech giant has churned out a steady stream of data supporting the device’s ability to improve outcomes for Type 1 diabetes (IDDM) patients. The latest proof of the MiniMed 780G’s promise arrives in the form of study results published in The Lancet Diabetes & Endocrinology, Medtronic announced Thursday.
The MiniMed 780G system has been cleared in Europe since 2020. Medtronic submitted it to the FDA for U.S. approval in the spring of 2021 but is still awaiting a decision, slowed down by the roadblocks caused by a late 2021 warning letter from the agency that called out quality control issues at the California headquarters of its diabetes business.
In the company's Adapt trial, an insulin pump with an algorithm was compared to the gold standard of care for managing diabetes, which consists of a combination of several daily insulin injections and irregular check-ins using a continuous glucose monitor. The MiniMed device ultimately triumphed in a number of head-to-head comparisons, lowering average blood sugar levels and lengthening the time that individuals stayed within their ideal glycemic ranges, among other things.
The algorithms in the MiniMed 780G gadget enable the wearer's insulin dosages to be automatically adjusted when necessary. Based on wirelessly transmitted data from Medtronic's Guardian glucose monitor, which requires two daily fingerstick calibrations and checks blood sugar levels every five minutes, it makes those decisions, reports FierceBiotech. The MiniMed mobile app that comes with it allows users to monitor those automatic changes. It shows previous trends and real-time glucose readings and may also alert users if their blood sugar levels are rising or falling outside of a predefined range.
The Adapt trial involved 82 people who, before the study, had all been managing their diabetes with a combination of several daily injections and sporadic CGM scans. The patients' average HbA1C levels at the beginning of the trial were above 8%, significantly higher than the advised maximum of 5.7%, despite the fact that their glucose monitors were programmed to take readings roughly nine times each day.
The experimental group in the research saw an average decline in their blood sugar levels of 1.4% after utilizing the MiniMed 780G system for six months. While none of the individuals in the control group—who continued to rely on the previous standard of care technique to manage their diabetes—reached that level, more than a quarter of those in that group had their HbA1C levels fall below the 7% threshold.
Along with the decrease in blood sugar, by the end of the first six months, those using the MiniMed 780G device were spending an average of 27.6% more time than the control group in their optimum glucose ranges. This equates to an extra 6.6 hours of range time per day, and Medtronic reported that benefits in range time were even more pronounced overnight when the MiniMed system's algorithms were solely in charge of insulin administration.