番茄社区

CHICAGO -- Kids with type 1 diabetes as young as 7-years-old could benefit from a closed-loop insulin pump system, researchers reported here.

In the trial that tested Medtronic's MiniMed 670G hybrid closed-loop system in patients with type 1 diabetes, all age groups saw significant improvements in HbA1c levels over the 3-month study, according to Michael Alan Wood, MD, of the University of Michigan in Ann Arbor, and colleagues:

• Children (7-13 years): 7.9% to 7.5% (P<0.001)
• Adolescents (14-21 years): 7.7% to 7.1% (P<0.001)
• Adults (22-75 years): 7.3% to 6.8% (P<0.001)

Percentage of the time spent in target blood glucose range -- between 70 to 180 mg/dL -- also saw significant improvements with the system across the board:

• Children: 56.2% to 65.0% (P<0.001)
• Adolescents: 60.4% to 67.2% (P<0.001)
• Adults: 68.8% to 73.8% (P<0.001)

The percentage of time spent in hypoglycemia (≤70 mg/dL) or hyperglycemia (>180 mg/dL) was also lowered across all age groups, they reported at ENDO 2018.

The first-ever "bionic pancreas" system was approved in September 2016, but is currently only indicated for patients, ages ≥14 years.

"Achieving and maintaining glycemic control as set by the American Diabetes Association remains a challenge for everybody -- all patients with type 1 diabetes," Wood noted, adding that "automatic insulin delivery systems to help maintain normal glucose values during the day are now a reality."

The multicenter trial recruited a total of 105 children with type 1 diabetes for the analysis. Their data was then compared against prior data from the pivotal trials for the closed-loop system, which included 30 adolescents and 94 adults. Similar to the original study, the current analysis included a 2-week run-in phase where the system was used in "manual mode," which was then followed by a 3-month study phase with the systems working in "auto mode."

During the study phase, there were no severe hypoglycemic events or any reports of diabetic ketoacidosis. No other serious adverse events related to the system were reported.

After the study period, more than 97% of children continued using the device in a continued access program.

When asked if there are any concerns with using this system in a younger age group, Wood told 番茄社区, "We had a very big concern with automating insulin delivery in any age group, let alone little ones."

He highlighted that families of young children found great benefit with the device, while over 97% of the children went on to continue using the device in a 2-year continued access program after the study period. "The night in particular for families and the parents of young children in our group, age 7 through 14, is very well-controlled by this system and that is such a reassurance to the families. It works and it works really well."

Robert Rapaport, MD, of Icahn School of Medicine at Mount Sinai in New York City, told 番茄社区, "This is a very promising study. It does have some limitations, such as lack of a comparative control group, relatively few children in the study, and only a 3-month observation period."

"Still, even with those caveats, I do think this pump will become one of the key treatment modalities that will be available for the management of even young children with type 1 diabetes," he added.

The device "should work just great with somebody with type 2 diabetes -- in fact, it would probably work even better," Wood said. "The reason, of course, is because the body still maintains some ability to release insulin in type 2, which will respond to physiologic criteria."

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