In-home hybrid closed-loop system MiniMed from Medtronic can help kids with Type 1 diabetes improve their glycemic outcomes, according to a recent abstract that was presented at the meeting of Endocrine Society in Chicago on Saturday.
"The MiniMed 670G system can effectively manage diabetes and lead to improved time in the target glucose range and glycated hemoglobin (hemoglobin A1c) for individuals with Type 1 diabetes between the ages of seven and 75 who require at least eight units of insulin daily,” Dr. Michael Alan Wood, associate professor of pediatrics and clinical director of the Pediatric Diabetes Program at the University of Michigan Medical School in Ann Arbor, said in a statement.
Right now the MiniMed 670G system is first continuous glucose monitoring system approved by the FDA to control automated insulin delivery via a hybrid closed loop system. A closed-loop system, often called an “artificial pancreas,” combines a CGM and an insulin pump to regulate a user’s insulin with minimal action required by the patient. This system doesn’t quite do that yet — it does require the user to manually request insulin doses to counter carbohydrate consumption.
The study, which was funded by Metronic, set out to look at the impact of the system on children aged seven to 13 years. Currently the MiniMed is only FDA approved for individuals over the age of 14. Wood and colleagues compared data from the children with 30 adolescences aged 14 to 21 years and 75 adults over the age of 22.
In all three age groups, researches saw a reduction in HbA1c, a reduction in overall and night time glucose variability, an increase in time in targeted glucose range, and a reduction of time outside of the goal blood glucose range, Wood said at his presentation.
“What we are really excited about is the percentage of time the subjects spent in the goal range,” Wood said at the Endocrine Society press conference on Saturday. “The 71-181 mg/dl range went from 56 to 65 percent in the pediatric group, 60 to 67 percent in the adolescent and 68 to 73.8 percent in the adults.”
Participants first went through a 2-week run-in phase that captured data about the patients at baseline. They then began the three-month study phase. Researchers reported that during the pediatric study there were no severe hypoglycemia or diabetic ketoacidosis episodes.
At the end of the study participants were able to opt into a continued access program where they could continue on with the MiniMed system. All but three children opted in, while 80 percent of adolescents and adults chose to continue, according to Wood.
“These findings indicate improved glycemic outcomes of children with Type 1 diabetes using the MiniMed 670G system, similar to that observed for adolescents and adults, and suggest that the therapy can effectively manage diabetes across these age groups,” Wood and colleagues wrote in the abstract.
This isn’t the first study that has looked at youth and the use of a closed-loop system. In January a study came out that looked at the use of a closed-loop control system and how it impacted intensive outdoor physical activities for youth aged 10 to 16 years. The study found that participants who used the artificial pancreas maintained a healthy blood sugar level more often than participants that used the traditional open-loop system. In this study researchers used a closed-loop system that the University of Virginia developed.
The Medtronic MiniMed was first approved by the FDA in 2016, but since then several other companies have started developing closed-loop CGMs. For example, last July Senseonics and TypeZero teamed up with pharmaceutical and medical device company Roche to launch three European clinical trials of their combined closed-loop system.