Medtronic has secured a new approval in Europe, greatly expanding the reach of its MiniMed 780G pump system—including for people with Type 2 diabetes who require insulin.
The CE mark also opens it up to women during pregnancy as well as to children as young as age 2 with Type 1 diabetes.
The green light comes as Medtronic plans to spin out its diabetes care division as an independent company—which will also carry the MiniMed moniker—with its more than 8,000 global employees and a nearly $3 billion device portfolio.
For people with Type 2 diabetes, Medtronic said a pivotal, open-label trial of 95 people showed that the insulin pump, guided by continuous glucose monitor readings, helped lower HbA1c by an average of 0.7 percentage points after about three months. While the total of daily insulin doses increased during the study period, the users’ time in a healthy glucose range increased from 72% at the start of the trial to about 80%.
At the same time, the company pointed to real-world 780G data from more than 26,400 users with Type 2 diabetes, showing a time below range of less than 1%. Medtronic said it is also working with the FDA to expand the pump’s indications in the U.S., where it is approved for people with Type 1 diabetes as young as age 7.
Earlier this year, at the American Diabetes Association’s annual scientific sessions in Chicago, Medtronic presented clinical data following children between the ages of 2 and 6, and examining the 780G pump’s use for Type 1 diabetes at home.
The system demonstrated 0.6% lower HbA1c and 9.9% higher time in range, compared to a manual pump delivery mode or closed-loop insulin dosing without the 780G’s autocorrections. The study’s results were also published in The Lancet Diabetes & Endocrinology.
Additionally, in pregnant women with Type 1 diabetes—who need a much tighter glucose target range—the MiniMed 780G system achieved an average time of 66.5% compared to traditional insulin therapy in a randomized European trial of about 100 participants. The study showed improvements in overnight time in range, but not overall time in range, and did lower the time spent below the target glucose levels.