Dive Brief:

• FDA has approved Medtronic’s MiniMed 770G hybrid closed loop diabetes management system for use in children between the ages of 2 and 6 years old with Type 1 diabetes. It's the first legally marketed device to automatically adjust insulin delivery based on continuous glucose monitor values for this patient population, the agency said in its announcement Monday afternoon.

• The approval covers a Bluetooth-enabled version of the 670G device that became the first hybrid closed looped system to come to market in the U.S. in 2016.

• Medtronic introduced 770G to bridge the gap to the 780G, which is set to launch in Europe this fall but suffered a delay in the U.S.

Dive Insight:

Regaining lost ground in the diabetes tech market is one of new Medtronic CEO Geoff Martha's primary focuses. Expanding its product line to younger patients is one step.

Earlier this year, Medtronic published data from a clinical trial that assessed the use of its MiniMed 670G in children aged 2 to 6 years. Participants were in their target glucose range 64% of the time during the in-clinic portion of the trial and 65% of the time in the longer, pivotal period of the study.

Medtronic’s researchers concluded the data show the glycemic outcomes achieved in the in-clinic portion of the clinical study “were managed well and compared closely with those during the Auto Mode-enabled study phase of the pivotal trial.”

Now, Medtronic has used the data to bring a modified version of the 670G to market in children between the ages of 2 and 6 years old. The approval marks the first time such a device has been authorized for use in that age group. Medtronic and Tandem Diabetes Care previously only won approvals for their competing devices in children ages 6 or 7 years and older.

While the target demographic is new, the device itself is largely the same as the existing 670G. At one point, Medtronic looked set to make the 780G the focal point of its hybrid closed loop business in 2020. That plan changed earlier this year when the anticipated approval of the 780G was pushed back. In June, Medtronic CFO Karen Parkhill told investors the current plan is to “hopefully” launch the 780G in the U.S. this fiscal year, which ends in April 2021.

The 780G automatically adjusts basal insulin rates every five minutes and supports the selection of a lower glucose target than the 670G. While Medtronic has received a CE mark for the 780G and expects to launch the device in Europe in the fall, U.S. customers will have to wait longer. But U.S. customers who opt to use the 770G rather than wait for its successor will have Bluetooth capabilities, both immediately and once the 780G is on the market. 

“[Bluetooth] enables caregivers and parents to be able to monitor remotely the patient's glucose levels. And with the Bluetooth capability, as soon as we launch 780G, it will enable the remote download of the advanced hybrid closed-loop technology, which the 780G offers, onto the 770 hardware platform,” Parkhill said. Medtronic has previously said it will offer 770G users the software update for free.