A Study Comparing User Experience of Different Delivery Devices for Glucagon

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Nasal Glucagon Device (NG)
* Device: GEK
* Drug: IM Glucagon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |