A Study Comparing User Experience of Different Delivery Devices for Glucagon
Condition: Healthy
Intervention: Nasal Glucagon Device (NG); GEK; IM Glucagon
Intervention description: NG devices will be provided empty of drug product; Used to administer glucagon intramuscularly (IM); Administered IM via GEK
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to learn more about different devices for delivering glucagon
      during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be
      carried out using medical manikins to simulate real life scenarios. No drug will be
      administered to humans. Part A will last approximately 17 days for Trained Users and
      Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained
      Users. Each part will be separated by approximately 7 days.
    

Eligibility criteria:

        Inclusion Criteria:

        All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):

          -  Are able to understand the purpose and procedure of the study and to give written
             informed consent to show willingness to participate in the study

        Trained Users only:

          -  Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2
             Diabetes Mellitus (T2DM)

          -  Are close friends/relatives of a patient with T1DM or T2DM on insulin

          -  Have not previously administered any rescue medications (e.g. epinephrine, glucagon,
             narcan or seizure medications)

        Untrained Users only:

          -  Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with
             T1DM or T2DM

          -  Have not previously administered any rescue medications (e.g. epinephrine, glucagon,
             narcan or seizure medications)

        Exclusion Criteria:

        All participants (Trained Users, PWDs and Untrained Users):

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study

        Trained Users and Untrained Users only (i.e. the participants involved in the simulations):

          -  Are currently enrolled in a clinical study involving any type of medical research
             judged not to be scientifically or medically compatible with this study

          -  Are judged by the investigator as being likely to have difficulty performing the
             administration due to physical, cognitive and/or severe psychiatric disorder

          -  Are judged by the investigator as being trained or experienced in performing rescue
             drug administration

          -  Are judged by the investigator as being trained or experienced in performing
             high-fidelity simulations of drug administration

          -  Have received formal training in a medical field, and/or worked in this field within
             the prior 5 years; or otherwise are judged by the investigator as being trained or
             experienced as a first responder