G-Pen™ for Hypoglycemia Rescue in T1D Patients

Experimental: Glucagon

1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg

Droga: Glucagón

Otros nombres:

• G-Pen™ (inyección de glucagón)

Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment

For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to >70 mg/dL within 30 minutes of treatment being considered a positive response.

Time to Plasma Glucose > 70 mg/dL

Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.

Time to Resolution of Induced Hypoglycemia Symptoms

Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.