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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
99
NG devices will be provided empty of drug product
Used to administer glucagon intramuscularly (IM)
Administered IM via GEK
High Point Clinical Trials Center
High Point, North Carolina, United States
Percentage of Trained Users That Performed a Successful Administration for Each Device
Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Time frame: Part A: Days 8 - 9 and Days 15 - 17
Percentage of Untrained Users That Perform a Successful Administration for Each Device
Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Time frame: Part B: Day 1 and Days 8-9
Average Time for Trained Users to Successfully Administer One Device Over the Other
Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.
Time frame: Part A: Day 8 and Days 15-17
Average Time for Untrained Users to Successfully Administer One Device Over the Other
Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.
Time frame: Part B: Day 1 and Days 8-9
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other
Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.
Time frame: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
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Percentage of Participants (PWD) That Prefer One Device Over the Other
Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.
Time frame: Part A: Days 15 - 17
Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other
Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.
Time frame: Part A: Days 15 -17 and Part B: Days 8 - 9