Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
Status:
Terminated
Trial end date:
2020-02-10
Target enrollment:
Participant gender:
Summary
This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the
primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion
(CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM),
subjects will have their baseline hypoglycemia counter-regulatory response hormones
quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility
requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects
will receive blinded study drug for 4 weeks, and they will be followed for an additional 26
weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at
baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.