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 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.
The company’s Adapt trial put the algorithm-equipped insulin pump to the test against one standard of care for diabetes management—a combination of multiple daily insulin injections and intermittent check-ins with a continuous glucose monitor. Ultimately, the MiniMed system came out on top in multiple head-to-head comparisons including in reducing average blood sugar levels and increasing the amount of time participants spent within their ideal glycemic ranges.
The MiniMed 780G device is equipped with algorithms that can automatically adjust a wearer’s insulin dosages as necessary. It makes those decisions based on readings wirelessly transmitted from Medtronic’s Guardian glucose sensor, which requires two fingerstick calibrations per day and analyzes blood sugar levels every five minutes.
Users can track those automatic adjustments through the accompanying MiniMed mobile app, which displays real-time glucose readings and recent trends, and can also send out alerts if the user’s blood sugar is spiking or dipping outside of a preset range.
The Adapt trial focused on 82 participants, all of whom had been relying on a combination of multiple daily injections and periodic CGM scans to manage their diabetes before the study began. Though their glucose monitors were set to perform readings about nine times a day, the participants started the study with average HbA1C levels above 8%—well above the recommended maximum of 5.7%.
After using the MiniMed 780G system for six months, the trial’s experimental group experienced an average reduction of 1.4% in their blood sugar readings. More than a quarter of those in that group saw their HbA1C levels drop below the 7% mark, while none of the control group participants—who continued to rely on the original standard of care method to manage their diabetes—reached that point.
Alongside that drop in blood sugar, by the six-month mark, those using the MiniMed 780G system were spending an average of 27.6% more time in their ideal glucose ranges compared to the control group. That adds up to about 6.6 additional hours spent in range each day, and Medtronic noted that time in range saw even greater improvements overnight, when the MiniMed system’s algorithms were solely in control of insulin dosing.