Clinical trial NCT03765502: A Study Comparing User Experience of Different Delivery Devices for Glucagon
Official title: A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

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 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

Primary outcomes:
measure: Percentage of Trained Users That Performed a Successful Administration for Each Device
timeFrame: Part A: Days 8 - 9 and Days 15 - 17
Secondary outcomes:
measure: Percentage of Untrained Users That Perform a Successful Administration for Each Device
timeFrame: Part B: Day 1 and Days 8-9
measure: Average Time for Trained Users to Successfully Administer One Device Over the Other
timeFrame: Part A: Day 8 and Days 15-17
measure: Average Time for Untrained Users to Successfully Administer One Device Over the Other
timeFrame: Part B: Day 1 and Days 8-9
measure: Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other
timeFrame: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
measure: Percentage of Participants (PWD) That Prefer One Device Over the Other
timeFrame: Part A: Days 15 - 17
measure: Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other
timeFrame: Part A: Days 15 -17 and Part B: Days 8 - 9
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: