Pediatric and adult Type 1 diabetes patients receiving a hybrid closed-loop artificial pancreas therapy demonstrated improved glucose control and lower risk of hypoglycemia compared to those managing their own glucose levels with an insulin pump and continuous glucose monitor, according to a study published today in the Lancet.

The investigation, which was supported by JDRF and presented at the European Association for the Study of Diabetes’ annual meeting in Berlin, randomly assigned the hybrid closed-loop system to 46 patients, and the sensor-augmented pump therapy to 40 patients as a control. Participants aged six years and older used their provided systems for 12 weeks, during which time researchers collected and then analyzed data regarding time within target glucose concentration range and other metrics.

While those given the hybrid closed-loop system recorded significantly more time within an acceptable range, variations in glucose concentrations, total daily insulin doses, and body weights were similar across the study groups. No severe hypoglycemia events occurred in either group, and two participants in each group experienced significant hyperglycemia.

What’s the impact

New pump and CGM technologies have substantially reduced the burden of home glucose management, and a insulin delivery system with even partial automation could further improve their quality of life — especially for pediatric patients for whom round-the-clock management is more challenging.

What’s the trend

FDA cleared its first closed-loop insulin delivery system, Medtronic’s MiniMed device, in 2016, and expanded the indication of the MiniMed 670G earlier this year to include children aged seven years and older. In addition, the last few years have seen a handful of studies investigating the impact closed-loop and hybrid closed-loop systems could have in glucose control in various populations and use cases.

On the record

“[This] study is significant in that it adds to the ever-growing body of evidence showing that closed-loop insulin delivery systems improve outcomes and reduce burden for people with type 1 diabetes," Daniel Finan, research director at study sponsor JDRF, said in a statement. "In particular, this study demonstrates that people with diabetes who have sub-optimal control can benefit greatly from such technology."