A new artificial pancreas was found to be more effective vs current treatments at controlling levels of blood sugar during the day and night in people with type 1 diabetes mellitus (T1DM).
In the new multicenter randomized clinical trial, published October 16 in the New England Journal of Medicine, patients who used the new closed-loop system increased by 2.6 hours/day the amount of time spent in the target blood glucose level range (70-180 mg/dL) since the beginning of the trial while those in the control group, who used a sensor-augmented pump (SAP) system, remained unchanged.
“This artificial pancreas system has several unique features that improve glucose control beyond what is achievable using traditional methods,” co-lead author Boris Kovatchev, PhD, founding director, University of Virginia Center for Diabetes Technology, Charlottesville, said in a press release. “In particular, there is a special safety module dedicated to prevention of hypoglycemia, and there is gradually intensified control overnight to achieve near-normal blood sugar levels every morning.”
This 6-month study was the third phase in a series of trials that are part of the International Diabetes Closed Loop (iDCL) study. The study enrolled 168 patients with T1DM (50% women) who ranged in age from 14 to 71 years. Patients were randomly assigned in a 2:1 ratio to the closed-loop group or the control group for 26 weeks.
Patients in the closed-loop group (112) were trained on the new system, Control-IQ, which consists of an insulin pump and a continuous glucose monitor (CGM). Control-IQ is designed to predict blood glucose levels 30 minutes ahead and automatically adjusts insulin dose all day.
Patients in the control group (56) used SAP therapy with a CGM and insulin pump that did not automatically adjust insulin throughout the day. Both groups attended follow-up visits every 2-4 weeks to download and review device data.
The mean percentage of time with glucose levels in the target range increased in the closed-loop group from 61% at baseline to 71% during the 6 months whereas the control group remained unchanged at 59%.
Artificial pancreas users’ also had less hyperglycemia and hypoglycemia as well as better A1c levels vs control group participants. No serious hypoglycemia events occurred in either group.
Researchers noted, however, that the majority of study participants were using either a CGM (70%) or an insulin pump (79%) at the time of enrollment, which is significantly greater than the reported usage in the general T1DM population.
“These data may reflect an interest in and willingness to use a closed-loop system among patients who were already using devices as part of diabetes management,” researchers stated. “However, our results appeared to be similar in patients who were not using a pump or a continuous glucose monitor before the trial.”