Status:
COMPLETED
A Study Comparing User Experience of Different Delivery Devices for Glucagon
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2019
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03765502
Start Date
November 19 2018
End Date
January 3 2019
Last Update
March 20 2020
Active Locations (1)
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1
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265