Medtronic's MiniMed 780G Insulin Pump Secures Expanded European Approvals

Medtronic, a leading medical device company, has announced significant expansions to the approved uses of its MiniMed 780G insulin pump system in Europe. The new CE Mark approvals broaden the device's reach to include people with type 2 diabetes requiring insulin, pregnant women, and children as young as two years old with type 1 diabetes.

Expanded Indications for MiniMed 780G

The MiniMed 780G, Medtronic's flagship insulin pump, has received regulatory clearance for use in several new patient populations:

Type 2 diabetes patients requiring insulin therapy
Pregnant women with diabetes
Children aged 2-6 years with type 1 diabetes

These approvals significantly increase the potential user base for the device in European markets.

Clinical Data Supporting Expanded Use

Type 2 Diabetes

A pivotal, open-label trial involving 95 people with type 2 diabetes demonstrated the efficacy of the MiniMed 780G system:

Average HbA1c reduction of 0.7 percentage points after approximately three months
Increase in time within healthy glucose range from 72% to about 80%
Real-world data from over 26,400 type 2 diabetes users showed less than 1% time below range

Young Children with Type 1 Diabetes

Clinical data presented at the American Diabetes Association's annual scientific sessions and published in The Lancet Diabetes & Endocrinology showed promising results for children aged 2-6 years:

0.6% lower HbA1c compared to manual pump delivery or closed-loop systems without autocorrections
9.9% higher time in range

Pregnancy

A randomized European trial of approximately 100 pregnant women with type 1 diabetes revealed:

Average time in range of 66.5% compared to traditional insulin therapy
Improvements in overnight time in range
Reduced time spent below target glucose levels

Medtronic's Strategic Moves

This expansion of the MiniMed 780G's indications comes as Medtronic prepares to spin out its diabetes care division as an independent company. The new entity, which will retain the MiniMed name, will encompass:

Over 8,000 global employees
A device portfolio valued at nearly $3 billion

Medtronic is also pursuing expanded indications for the MiniMed 780G in the United States, where it is currently approved for people with type 1 diabetes aged 7 and older.