A Study Comparing User Experience of Different Delivery Devices for Glucagon



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:November 19, 2018
End Date:December 31, 2018

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A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon

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 Persons
with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained Users. Each
part will be separated by approximately 7 days.


Inclusion Criteria:

All participants (Trained Users, Persons 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 persons 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
We found this trial at
1
site
High Point, North Carolina 27265
Principal Investigator: Melanie Fein
Phone: 855-687-4257
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mi
from
High Point, NC
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