A Study Comparing User Experience of Different Delivery Devices for Glucagon

A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Nasal Glucagon Device (NG); Device: GEK; Drug: IM Glucagon

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27265
      • High Point Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal Glucagon Device (NG); Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.	Device: Nasal Glucagon Device (NG); NG devices will be provided empty of drug product
Active Comparator: Glucagon Emergency Kit (GEK); Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.	Device: GEK; Used to administer glucagon intramuscularly (IM); Drug: IM Glucagon; Administered IM via GEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Part A: Days 8 - 9 and Days 15 - 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
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.	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.	Part A: Days 15 -17 and Part B: Days 8 - 9

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): January 3, 2019
• Study Completion (Actual): January 3, 2019

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: 17156; I8R-MC-IGBM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes