A new closed-loop control system (also known as artificial pancreas) was found to be safe and effective at managing glucose levels in the blood of children as young as age six with type 1 diabetes, according to a study published in the New England Journal of Medicine.
The closed-loop control is an “all-in-one” diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers the insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.
The 4 month long study enrolled 101 children between ages 6 and 13 and assigned them to either the experimental group, which used the new artificial pancreas system or to the control group which used a standard CGM and separate insulin pump.
The study found that youth using the artificial pancreas system had 7% improvement in keeping blood glucose in range during the daytime, and a 26% improvement in nighttime control compared to the control group. The overall time-in-range goal for the artificial pancreas reflected a nearly 11% improvement, which translated to 2.6 more hours per day in range.
Study participants were instructed to continue about their daily lives so that the researchers could best understand how the system works in the typical routines of the children.
Nighttime control is of particular importance for people with type 1 diabetes, as severe, unchecked hypoglycemia can lead to seizure, coma or even death.
Sixteen adverse events, all classified as minor, occurred in the artificial pancreas group during the study, with most due to problems with the insulin pump equipment. Three events occurred in the control group. No cases of severe hypoglycemia or diabetic ketoacidosis occurred during the study.
The artificial pancreas technology used in this study, the Control-IQ system, has an insulin pump that is programmed with advanced control algorithms based on a mathematical model using the person’s glucose monitoring information to automatically adjust the insulin dose.
This four-month study was part of a series of trials conducted in the International Diabetes Closed-Loop (iDCL) Study. The trial was conducted by the National Institutes of Health at four paediatric diabetes centres in the United States.