A Study Comparing User Experience of Different Delivery Devices for Glucagon

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IM Glucagon; Device: GEK; Device: Nasal Glucagon Device (NG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03765502

I8R-MC-IGBM (Other Identifier)

17156

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Nasal Glucagon Device (NG)

Experimental group

Description:

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

Treatment:

Device: Nasal Glucagon Device (NG)

Glucagon Emergency Kit (GEK)

Active Comparator group

Description:

Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

Treatment:

Device: GEK

Drug: IM Glucagon