Artificial pancreas system of Tandem, Dexcom diabetes tech adds 3 hours to toddlers' time in range: NIH study

In the not-so-distant future, the hottest new tech on the playground could be an artificial pancreas system.

A closed-loop system that combines Dexcom’s continuous glucose monitor with Tandem Diabetes Care’s insulin pump and algorithm to automate insulin delivery helped improve glycemic control for toddlers about as well as it does for older children and adults, according to newly released study results.

The artificial pancreas system works by taking in the blood sugar measurements captured by Dexcom’s CGM every five minutes, then putting them through Tandem’s Control-IQ algorithm. The algorithm analyzes the readings to predict how the user’s glucose levels might change within the next 30 minutes, then uses those forecasts to automatically adjust the amount of insulin delivered by Tandem’s t:slim X2 pump.

The system is meant to work seamlessly in the background, without requiring many manual adjustments from users—though they still have to input information about meals, sleep and exercise to keep the algorithm running accurately.

The study—which was funded by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases—was published in the New England Journal of Medicine on Thursday. It recruited just more than 100 patients between the ages of 2 and 5 with Type 1 diabetes. Controlling diabetes among that age group is notoriously difficult since blood sugar levels in young children are more prone to sudden fluctuations.

Half of the participants were taught to use the automated system, and the other half relied on a Dexcom CGM and either a standard insulin pump or multiple daily injections, whichever they’d already been using before the study began, to manually manage their diabetes.

After the 13-week study period, the kids using the artificial pancreas tech saw their average time in range jump from a baseline of 57% to 69%—an addition of about three hours per day, according to Tandem—compared to the control group’s increase from a baseline of 55% to just 56% over the course of the three months.

The difference between the groups was even starker when looking at their overnight data. Between 10 p.m. and 6 a.m., the artificial pancreas group spent an average of 18% more time in the ideal glucose range than the control group, according to the NIH.

Meanwhile, all of the participating children experienced similarly minimal improvements in their average blood sugar levels, with HbA1c drops of less than 1%. The entire group also registered low amounts of time spent in hypoglycemia—with two cases of severe hypoglycemia in the artificial pancreas group and one in the control group—though the Control-IQ group experienced about 5.4% less time in hyperglycemia than the control group.

Additionally, as the NIH noted, another particularly promising aspect of the study is that those results were achieved even after more than 80% of the device training sessions and 90% of check-ins throughout the study took place virtually due to COVID-19 restrictions, suggesting a low difficulty for the high-tech system’s setup and use.

The combined system isn’t yet available to the toddler set, but the study results could potentially sway the FDA to expand its indication. Currently, though Dexcom’s latest G7 CGM has been cleared for users as young as 2 years old, Tandem’s Control-IQ technology is only indicated for those aged 6 and up.

The system has previously been tested in adults and older children, to similar effect. Among kids aged 6 to 13, for example, those using the all-in-one system in a 2020 study saw their overall time in range improve by more than 10%, adding about 2.6 more hours per day—the same improvement seen by users aged 14 and up in a study published the year before.