January 13, 2023 -- Patients with type 2 diabetes spent twice as much time in their target blood glucose range when using an artificial pancreas compared to standard therapy in a small clinical trial.
Writing in Nature Medicine, researchers at the University of Cambridge describe the latest stage of their work on CamAPS HX, an app that uses an algorithm to predict how much insulin is needed to keep blood glucose levels in the target range. When combined with a glucose monitor and insulin pump, the app completes an artificial pancreas capable of sensing glucose levels and titrating insulin in light of the data.
An earlier clinical trial tested a similar algorithm in patients with type 1 diabetes. That study looked at a hybrid closed loop system that required users to tell the artificial pancreas when they were about to eat to allow it to adjust the insulin.
Before moving into testing in type 2 diabetes, the researchers updated the system to eliminate the need for users to enter information about their meals. The team first tested the fully automated closed-loop glucose control system in type 2 diabetes in inpatients and people who required kidney dialysis.
The latest study is the first trial of the system in a wider population. Investigators enrolled 26 patients with type 2 diabetes not requiring kidney dialysis and randomized them to use the artificial pancreas or take the standard therapy of multiple daily insulin injections for eight weeks. At week eight, the groups switched over, so every patient tried both the investigational and control therapies.
While using the artificial pancreas, the blood glucose levels of participants were between 3.9 and 10.0 mmol/L -- the target range -- 66% of the time. Time in target range in the control group was 32%. Patients spent the rest of the time with glucose levels above 10.0 mmol/L. Persistently high blood sugar can lead to complications including nerve damage, vision problems, and life-threatening conditions.
No patients experienced dangerously low blood sugar levels during the study. One user of the artificial pancreas developed an abscess at the site of the pump cannula that resulted in their hospitalization.
On the strength of the data, the researchers plan to start a larger, multicenter clinical trial to support filings for regulatory approval. Charlotte Boughton, the University of Cambridge researcher who co-led the trial, explained what the device could mean for patients.
"Many people with type 2 diabetes struggle to manage their blood sugar levels using the currently available treatments, such as insulin injections. The artificial pancreas can provide a safe and effective approach to help them, and the technology is simple to use and can be implemented safely at home," Boughton said in a statement.