1. In a prospective cohort of 48 youths with type 1 diabetes mellitus (T1DM), use of needle-free glucagon nasal powder demonstrated similar pharmacokinetic and pharmacodynamics properties as intramuscular glucagon.
2. The adverse effects of both intranasal and intramuscular administration were transient and similar in frequency.
Evidence Rating Level: 2 (Good)
Study Rundown: Hypoglycemia is a life-threatening complication of T1DM resulting in sudden loss of consciousness and seizures. The current treatment for hypoglycemia in patients with T1DM outside the hospital setting involves the administration of intramuscular glucagon. However, previous observational trials have demonstrated significant difficulty with glucagon injections in the community due to improper technique. The purpose of this trial was to assess the pharmacodynamics and pharmacokinetic properties of a needle-free intranasal glucagon in youths with T1DM.
The study prospective recruited 48 participants between the age of 4 and 17 years of age. Each participant received either a weight-based dose of intranasal glucagon or a varying dose of intranasal glucagon. At the conclusion of the trial, both intramuscular and intranasal glucagon produced a significant increase in serum glucose levels within 20 minutes of administration. Additionally, serum glucagon levels, as well as time to peak plasma glucose, were similar between both groups. Overall, adverse events were similar between the 2 groups, with the intranasal group demonstrating a significant reduction in transient nausea compared to the intramuscular group. The result of this trial support the use of intranasal glucagon as a potential needle-free method in the treatment of hypoglycemia in youths with T1DM. However, the study was performed in fasting participants and does not represent efficacy of treatment for hypoglycemic episodes. Additional trials for real-life applications for treatment of hypoglycemia in patients with T1DM will help to confirm the effectiveness of intranasal glucagon.
In-Depth [prospective cohort]: This study included 48 children aged 4 to 17 years old with known T1DM. Key exclusion criteria included previous history of severe hypoglycemic episode or known history of epilepsy or seizures. The participants were divided into three cohorts based on age: 1) age 4 to <8, 2) age 8 to <12, and 3) age 12 to <17 years of age. The participants in the first 2 cohorts were randomly assigned to either received a weight based dose of intranasal glucagon or either 2mg or 3mg of intranasal glucagon in two separate session. The third cohort received 1mg intramuscular glucagon in the first session and 3mg intranasal glucagon in the second. All participants were provided a bolus of insulin to achieve a glucose nadir of <80 mg/dL prior to the study. Serial blood draws up to 90 minutes were performed after the administration of glucagon. The outcome of interest were the pharmacodynamics and pharmacokinetic properties of both intramuscular and intranasal glucagon, including glucagon levels and time to peak plasma glucose. At the conclusion of the trial, there were no significant difference in the number of participants who achieved a >25 mg/dL rise in serum glucose between both the intranasal and intramuscular glucagon groups. Additionally, there were no differences between the 2 groups with respect to maximum plasma glucose, or time to achieve maximum serum concentration of glucagon. With respect to adverse events, there was no difference between the two groups with respect to head/facial discomfort (p = 0.30). However, there was a significant reduction in the frequency of nausea experienced by the intranasal group versus the intramuscular group (p = 0.05).
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