Glucagon Nasal Powder - A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes

Phase 1 study conducted in seven pediatric centers by the T1D Exchange Intranasal Glucagon Investigators, evaluating safety, pharmacokinetics and pharmacodynamics of intranasal glucagon powder in 48 youth (4 to 17 years) with type 1 diabetes. The pediatric challenge is particularly relevant: emergency IM kits have complex weight-based dosing, and administration by teachers or peers frequently fails.

The design stratified participants into three age cohorts (4-<8, 8-<12, 12-<17 years). The two youngest cohorts were randomized to receive 2 mg or 3 mg intranasal in separate sessions, compared with a weight-based IM dose. The adolescent cohort received 1 mg IM and 3 mg intranasal in crossover sessions. In all cases, hypoglycemia was induced by IV insulin prior to rescue.

Results showed that all 24 IM doses and 58 of 59 intranasal doses produced ≥25 mg/dL elevation above nadir within 20 minutes — efficacy very close between the two routes. Notably, nausea occurred less frequently with the nasal route (42%) than with IM (67%), a clinically relevant finding for pediatric tolerability. The single 3 mg dose proved appropriate across the entire 4-17 year range, significantly simplifying the emergency protocol.

This work, together with the parallel adult study (Rickels 2016), supported FDA approval of Baqsimi in 2019 for use in adults and children ≥4 years. The practical impact is substantial: the single fixed dose eliminates weight-based calculations in crisis situations, and nasal administration is feasible by lay people without technical training — particularly important in daycares, schools and non-medical environments.