Conditions: Hypoglycemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief summary:
This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

Detailed description:
Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose \< 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.

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

Interventions: intervention 1: Glucagon
Intervention descriptions: intervention 1: None

Protocol document: