High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
NCT Number: NCT03765502
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
High Point, North Carolina, 27265, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):
Trained Users only:
Untrained Users only:
Exclusion criteria
All participants (Trained Users, PWDs and Untrained Users):
Trained Users and Untrained Users only (i.e. the participants involved in the simulations):
NG devices will be provided empty of drug product
Used to administer glucagon intramuscularly (IM)
Administered IM via GEK
Time frame: Part A: Days 8 - 9 and Days 15 - 17
Percentage of trained 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
Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Time frame: Part A: Day 8 and Days 15-17
Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.
Time frame: Part B: Day 1 and Days 8-9
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 A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
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 15 - 17
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 and Part B: Days 8 - 9
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.
Eli Lilly and Company
Industry
A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details