ADA: A Skin Patch for Insulin Delivery

The first results from an investigational transdermal insulin delivery system suggest that it is possible to deliver insulin through the skin. But, the bioavailability and biopotency of the insulin is significantly less than insulin delivered by injection, researchers reported Tuesday at the American Diabetes Association meeting here.

The skin provides a significant barrier to insulin, said Lutz Heinemann, Ph.D., of the Profil Institute for Medicine in Neuss, Germany, where the patch is being evaluated along with researchers in Israel.

His system requires that the skin be pre-treated with radio-frequency electrical energy that is delivered by a hand-held device, about the size and shape of a computer mouse.

"The radio-frequency device creates a network of microchannels in the skin," he said. The microchannels permit "the systemic absorption of regular insulin."

Dr. Heinemann and colleagues applied patches containing 150 U of Humulin R U-500 (human insulin) to the radio-frequency treated forearms of five healthy volunteers. Insulin was then measured by manual glucose clamp. Following the patch test, the subjects were crossed over to insulin injection, 10 U subcutaneous, and the glucose clamp measure was repeated.

Maximum serum insulin following the patch was 17 µU/ml after 2 to three hours versus 25 µU/ml during the same time period for injected insulin.

"The relative bioavailablity of the patch was about 6.5%, which corresponded to a delivery of about 10U," he said. "The biopotency was 5.6%."

The only toxicity was a slight erythema at the site of the patch but "that completely resolved," he said.

"This was a proof of concept study and I think it succeeded," Dr. Heinemann said. He noted that the time-action profile for transdermal insulin makes it an unlikely candidate for mealtime insulin, but "I think that optimization of the time-action profile for basal supply and biopotency is necessary, and to my understanding, possible."

He concluded, "We have demonstrated that painless, basal insulin delivery is possible."

This study was published as an abstract and presented at a conference either as an oral or poster presentation. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

American Diabetes Association 65th Annual Scientific Sessions: Heinemann L et al. "Transdermal Delivery of Insulin: First Results Obtained with a Novel Approach in a Clinical Experimental Study." Abstract 360.

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DID YOU KNOW:
A recent study presented at the ADA Scientific sessions showed that most patients reach their maximum post meal glucose 72 to 74 minutes after eating. This seems to indicate that current recommendations (Standards of Medical Care in Diabetes-2006, Diabetes Care) to measure postprandial glucose 2 hours after the start of the meal probably underestimate the peak glucose value in most patients treated with prandial short acting insulin analogues.
Use of the CGMS® To Assess the Optimal Time To Measure Postprandial Glucose, SANDRINE DAENEN, AGNES SOLA, et.al