A team of U.S. bioengineers has developed a glucose-responsive insulin patch that could one day monitor and manage glucose levels in people with diabetes. The researchers have successfully tested the patch in insulin-deficient diabetic mice and minipigs, and are now applying for FDA approval of clinical trials in humans.

Our main goal is to enhance health and improve the quality of life for people who have diabetes,” said Professor Zhen Gu, a researcher at the University of North Carolina at Chapel Hill, North Carolina State University, Raleigh, and the University of California, Los Angeles, and the lead author of a paper published in the journal Nature Biomedical Engineering.

“This smart patch takes away the need to constantly check one’s blood sugar and then inject insulin if and when it’s needed. It mimics the regulatory function of the pancreas but in a way that’s easy to use.”

The team’s adhesive patch monitors blood sugar, or glucose. It has doses of insulin pre-loaded in very tiny microneedles, less than one-millimeter in length that deliver medicine quickly when the blood sugar levels reach a certain threshold.

When blood sugar returns to normal, the patch’s insulin delivery also slows down.

“The advantage is that it can help prevent overdosing of insulin, which can lead to hypoglycemia, seizures, coma or even death,” the scientists said.

The microneedles used in the patch are made with a glucose-sensing polymer that’s encapsulated with insulin.

Once applied on the skin, the microneedles penetrate under the skin and can sense blood sugar levels. If glucose levels go up, the polymer is triggered to release the insulin.

Each microneedle is smaller than a regular needle used to draw blood and do not reach as deeply, so the patch is less painful than a pin prick.

Each microneedle penetrates about a half millimeter below the skin, which is sufficient to deliver insulin into the body.

In the new experiments, the smart patch successfully controlled glucose levels in minipigs with type I diabetes for about 20 hours.

“I’m glad the team could bring this smart insulin patch one more step close to reality, and we look forward to hopefully seeing it move forward to someday help people with diabetes,” said MIT Professor Robert Langer, co-author of the study.

The technology has been accepted into the U.S. FDA’s Emerging Technology Program, which provides assistance to companies during the regulatory process.

The researchers are applying for FDA approval for human clinical trials, which they anticipate could start within a few years

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