Bionic Pancreas Shows Promise for Type 1 Diabetes
Device removes guesswork from insulin therapy, reduces low blood sugar episodes, study finds
In the adults, average daily blood sugar levels were 159 milligrams per deciliter (mg/dL) on their usual management. On the bionic pancreas, that dropped to 133 mg/dL. The amount of time spent with low blood sugar levels was nearly halved -- from just over 7 percent on usual care to about 4 percent on the bionic pancreas, according to the study.
For the campers, aged 12 to 20, their usual care routines gave them an average blood sugar reading of 157 mg/dL, while they had an average of 138 mg/dL on the bionic pancreas. Time spent with low blood sugar levels were slightly reduced in the campers. The trials were funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.
Both Damiano and his co-author, Dr. Steven Russell from the Massachusetts General Hospital Diabetes Unit in Boston, were especially pleased that the device worked on everyone.
"No one was left behind. That was really encouraging," said Russell.
"A cure is what we hope for, but this is a bridge until that happens. Although we're not totally normalizing blood sugar levels, everybody gets below what's predicted to be an A1C of 7. We could keep people safe and dramatically reduce the risk of complications," said Russell.
A1C is a long-term measure of blood sugar levels -- about two to three months. The American Diabetes Association A1C goal for most people is under 7 to avoid diabetes complications. However, because of the many variables involved in diabetes care, that's often difficult to consistently achieve.
"These results are promising," said Aaron Kowalski, vice president of artificial pancreas research for JDRF (formerly the Juvenile Diabetes Research Foundation).
"And, from the patient experience, it's hard to underestimate the reduction of burden -- not having to make as many decisions, not being awakened in the middle of the night," said Kowalski, who has type 1 diabetes.
He noted that he does have concerns about artificial pancreas systems that rely on glucagon, because if the tubing delivering glucagon were to become blocked, potentially dangerous low blood sugar levels could result.
Russell said there are alarms that will sound if the tubing becomes blocked. And, in the new design for the fully integrated device, both the insulin tube and the glucagon tube will be on the same adhesive patch, so if one comes out, the other will, too.
There were no serious low blood sugar events in either the adults or the teens during the trials.
The next step begins Monday, with expanded outpatient trials. In the meantime, the researchers will continue to work on the fully integrated device, and hope to start clinical trials on that in 18 months or so, according to Damiano.