A Study Comparing User Experience of Different Delivery Devices for Glucagon

NCT ID: NCT03765502

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2019-01-03

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nasal Glucagon Device (NG)

Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

Group Type: EXPERIMENTAL

Nasal Glucagon Device (NG)

Intervention Type: DEVICE

NG devices will be provided empty of drug product

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.

Group Type: ACTIVE_COMPARATOR

GEK

Intervention Type: DEVICE

Used to administer glucagon intramuscularly (IM)

IM Glucagon

Intervention Type: DRUG

Administered IM via GEK

Interventions

Nasal Glucagon Device (NG)

NG devices will be provided empty of drug product

Intervention Type: DEVICE

GEK

Used to administer glucagon intramuscularly (IM)

Intervention Type: DEVICE

IM Glucagon

Administered IM via GEK

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

High Point Clinical Trials Center

High Point, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

I8R-MC-IGBM

Identifier Type: OTHER

Identifier Source: secondary_id

17156

Identifier Type: -

Identifier Source: org_study_id