A new critical trial, which is a research program conducted with patients to evaluate a new medical treatment, drug, or device, suggests that a new method to treat severe low blood sugar, also known as hypoglycemia, may come in an easy-to-administrate spray presentation.
This new way of treatment may help administrate doses of glucagon, a hormone that causes a prompt increase in blood sugar levels, to patients who are woozy or even unconscious due to severe low blood sugar.
At the moment, the only available option diabetics have to treat hypoglycemia comes as a powder that must be mixed with water, drawn into a syringe and then injected into the muscle. Patients who feel dizzy have a huge problem administrating the treatment themselves as it needs full attention.
The trial showed that that the nasal spray is nearly as effective in treating hypoglycemia as the traditional method but with the great plus of being much easier to administrate.
The trial was conducted with 75 adults with type 1 diabetes at eight clinics in the United States. All participants underwent induced hypoglycemia twice, and then received treatment once using the injection and once with the nasal spray.
The results showed that nasal spray worked about 99% of the time against 100% effectiveness from the injection. The nasal spray took about 16 minutes to increase blood sugar levels compared with 13 minutes for the injection. Both results seem to show a slight advantage on the injection over the nasal spray, however, it took just 16 to 26 seconds to administer the nasal spray, versus 1.9 to 2.4 minutes to give the injection.
Researchers cannot know yet if the delay of intranasal to work is clinically significant. Some are more concern than other.
Dr. Deena Adimoolam, an assistant professor of endocrinology and diabetes with the Icahn School of Medicine at Mount Sinai, in New York City who was not involved with the trial, said they didn’t know if the delay matters clinically
“In that time, you can have a seizure. You can lose consciousness. There could be catastrophic events. So it’s hard to tell whether the delay would be significant,” she said.
She also noticed that the trial examined, in average, 33-year-old people who are in less risk for severe hypoglycemia. 80-year-old people are twice as likely to suffer from insulin-induced hypoglycemia and nearly five times as likely to require hospitalization than younger people.
“I think it would have been even more interesting if this study looked at how this medication could help the elderly who are at even higher risk for insulin-related hypoglycemia than the age group evaluated in this study,” Adimoolam said.
As side effects, both forms of glucagon produced nausea in a little more than a third of users, but people using the nasal spray were more likely to report head and facial discomfort.