Artificial pancreas systems have shown in studies that they can be useful in managing diabetes among adults and adolescents, but the youngest children can be especially vulnerable to big swings in blood sugar levels.
Now, a program developed by researchers at the University of Cambridge has shown it can safely help deliver insulin as it is needed—and can be more effective at flattening curves in glucose readings compared to today’s devices—among children with Type 1 diabetes between one and seven years old.
A randomized clinical trial of the digital program, known as CamAPS FX, found children spent an additional two hours per day on average with their glucose levels within a healthy range—and over 70% of a 24-hour period without their blood sugar dropping too low or growing too high.
The hybrid, closed-loop system takes readings from a wearable continuous glucose monitor and makes predictions about how to vary insulin doses over the course of a day. Extra doses at mealtimes are controlled by a parent or caregiver. The results of the study, which followed 74 children in the U.K. and Europe for eight months, were published in The New England Journal of Medicine.
RELATED: FDA approves Medtronic's Bluetooth-controlled insulin pump for children ages 2 and up
The trial, funded in part by the European Commission, compared the artificial pancreas app to typical insulin pump therapies augmented with data from wearable sensors, but these devices relied on parents to review their child’s glucose levels and adjust doses throughout the day as necessary.
Participants in the study spent four months on the automated system and four months using the manual control therapy, in random order.
And if the difficulty of having a toddler keep their shoes on at times is any indication, managing Type 1 diabetes in very young children is an especially challenging endeavor for parents.
In addition to insulin sensitivity, unpredictable eating and changes in physical activity patterns—which in turn require highly variable doses of insulin—children are also particularly at risk of dangerous dips and spikes in blood sugar. Prolonged periods outside of a healthy range have been linked to long-term complications in brain development, according to the researchers.
RELATED: Insulet's upcoming artificial pancreas system shows gains at all ages in Type 1 diabetes
The app, which is being developed by Cambridge spinout CamDiab, delivered an improvement of nine percentage points in the amount of time study participants spent with hyperglycemia; there was no difference with the control group in hypoglycemia.
The artificial pancreas program also showed reductions in HbA1c, from a relatively low baseline of 7.3% down further to about 6.6%.
The constant need to manage insulin levels can also lead to poor sleep quality for children and parents. In the study, researchers found more than 80% of overnight blood sugar readings were in the target range.
“Parents have described our artificial pancreas as ‘life-changing’ as it meant they were able to relax and spend less time worrying about their child’s blood sugar levels, particularly at night time,” the study’s first author, Julia Ware, M.D., a clinical fellow at Cambridge’s Wellcome-MRC Institute of Metabolic Science, said in a statement.