BOSTON -- Glucagon in the form of nasal powder was effective in managing hypoglycemia in children and teens with type 1 diabetes, said a researcher here.
The glucagon nasal powder (GNP) comes in a single-use device that injects into a patient's nose, entering the body through the mucus. In the cohort of 48 patients ages 4 to 17, GNP was found to have similar efficacy to injected glucagon in the study which was presented at a poster session at the annual meeting of the American Diabetes Association here.
"While there's been studies assessing the use of intranasal glucagon in the adult population, this is the first examination of it in the pediatric population," said lead author , at the Yale School of Medicine, in an interview with 鶹ý.
An additional finding of the study was that a single dose, 3 mg, worked for the entire pediatric population, regardless of weight or age.
"We all know that the treatment of choice for severe hypoglycemia and the only one that is currently approved for use in an outpatient setting is injected glucagon, which requires multiple steps prior to administration," said Sherr. "And for our school-age children, it requires not just parents and family members but other people who are present throughout the child's day to provide assistance."
The study was conducted at seven T1D Exchange clinics. Eighteen patients 4 to 7 years old, 18 patients 8 to 11 years old, and 12 patients 12 to 17 participated in the study. The first group had had diabetes for an average of 2.9 years, the second for 4.9 years, and the third for 6.6 years.
The two youngest cohorts were randomized to one intramuscular (using a needle) or to two intranasal administrations. Those in the oldest cohort were randomly assigned 1 mg of intramuscular glucagon and 3 mg of intranasal glucagon, which was provided by , which makes the GNP device.
Using insulin, the patients' blood glucose was lowered to <80 mg/dL and 5 minutes passed before they were given glucagon. An increase in glucose ≥25 mg/dL within 20 minutes of administration was observed in all but one of the patients who had taken the intranasal glucagon; that patient blew his nose immediately following the administration of the glucagon, according to the study.
There were side effects with both of the methods, according to Sherr, but they were transient. Nausea occurred in two-thirds of the intramuscular patients and in 42% of the intranasal patients (P=0.06).
A study of GNP in the adult population showed that intranasal glucagon took a few minutes longer to take effect than the intramuscular glucagon, but Sherr said in the latest study of kids there was no such lag.
Disclosures
Jennifer Sherr disclosed no relevant relationships with industry.
Primary Source
American Diabetes Association
Source Reference: Sherr J, et al "Glucagon nasal powder: An effective alternative to intramuscular glucagon in youth with type 1 diabetes" ADA 2015.