Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-24 @ 6:07 PM
Study NCT ID:
NCT03765502
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-11-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing User Experience of Different Delivery Devices for Glucagon
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I8R-MC-IGBM | OTHER | Eli Lilly and Company | View |