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Completed

NCT Number: NCT03765502

A Study Comparing User Experience of Different Delivery Devices for 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Glucagon Device (NG)

Device

NG devices will be provided empty of drug product

GEK

Device

Used to administer glucagon intramuscularly (IM)

IM Glucagon

Drug

Administered IM via GEK

Primary outcomes

  1. Percentage of Trained Users That Performed a Successful Administration for Each Device

    Time frame: Part A: Days 8 - 9 and Days 15 - 17

    Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.

Secondary outcomes

  1. Percentage of Untrained Users That Perform a Successful Administration for Each Device

    Time frame: Part B: Day 1 and Days 8-9

    Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.

  2. Average Time for Trained Users to Successfully Administer One Device Over the Other

    Time frame: Part A: Day 8 and Days 15-17

    Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.

  3. Average Time for Untrained Users to Successfully Administer One Device Over the Other

    Time frame: Part B: Day 1 and Days 8-9

    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.

  4. Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other

    Time frame: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9

    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.

  5. Percentage of Participants (PWD) That Prefer One Device Over the Other

    Time frame: Part A: Days 15 - 17

    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.

  6. Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other

    Time frame: Part A: Days 15 -17 and Part B: Days 8 - 9

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2018
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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