Healthy
Conditions
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.
Interventions
DEVICENasal Glucagon Device (NG)
NG devices will be provided empty of drug product
DEVICEGEK
Used to administer glucagon intramuscularly (IM)
DRUGIM Glucagon
Administered IM via GEK
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Trained Users That Performed a Successful Administration for Each Device | 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
| Measure | Time frame | Description |
|---|---|---|
| Average Time for Trained Users to Successfully Administer One Device Over the Other | 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. |
| Average Time for Untrained Users to Successfully Administer One Device Over the Other | 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. |
| Percentage of Untrained Users That Perform a Successful Administration for Each Device | 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. |
| Percentage of Participants (PWD) That Prefer One Device Over the Other | 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. |
| Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | 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. |
| Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | 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. |
Countries
United States
Participant flow
Recruitment details
Trained Users were recruited alongside a participant with diabetes (PWD) with whom they were familiar. They were given a level of training intended to mimic that of a real-life caregiver on both devices: glucagon emergency kit (GEK) and nasal glucagon (NG). Untrained Users who have limited knowledge of severe hypoglycemia did not receive training.
Pre-assignment details
Trained users participated in Part A and untrained users participated in Part B.
Participants by arm
| Arm | Count |
|---|---|
| Part A Trained Users All trained participants in Part A | 33 |
| Part A Participants With Diabetes All participants with diabetes in Part A | 33 |
| Part B Untrained Users All participants in Part B. | 33 |
| Total | 99 |
Baseline characteristics
| Characteristic | Part A Trained Users | Part A Participants With Diabetes | Part B Untrained Users | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 0 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 32 Participants | 33 Participants | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 17 Participants | 13 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 15 Participants | 18 Participants | 46 Participants |
| Region of Enrollment United States | 33 Participants | 33 Participants | 33 Participants | 99 Participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 15 Participants | 60 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 18 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 33 |
Outcome results
Primary
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.
Time frame: Part A: Days 8 - 9 and Days 15 - 17
Population: All trained user participants who found both devices and participated in at least one simulation of a rescue device. Participants with diabetes (PWD) reporting group data not collected per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasal Glucagon (NG) | Percentage of Trained Users That Performed a Successful Administration for Each Device | 90.3 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Trained Users That Performed a Successful Administration for Each Device | 15.6 percentage of participants |
p-value: <0.0001McNemar
Secondary
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.
Time frame: Part A: Day 8 and Days 15-17
Population: All trained user participants who found both devices and completed at least one device simulation. PWD reporting group data not collected per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Glucagon (NG) | Average Time for Trained Users to Successfully Administer One Device Over the Other | 47.3 seconds | Standard Deviation 52 |
| Glucagon Emergency Kit (GEK) | Average Time for Trained Users to Successfully Administer One Device Over the Other | 81.8 seconds | Standard Deviation 18.6 |
Secondary
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.
Time frame: Part B: Day 1 and Days 8-9
Population: All untrained user participants who found both devices and completed at least one successful rescue device simulation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Glucagon (NG) | Average Time for Untrained Users to Successfully Administer One Device Over the Other | 44.5 seconds | Standard Deviation 47.8 |
| Glucagon Emergency Kit (GEK) | Average Time for Untrained Users to Successfully Administer One Device Over the Other | NA seconds | — |
Secondary
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.
Time frame: Part A: Days 15 - 17
Population: All PWD who completed the device preference questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nasal Glucagon (NG) | Percentage of Participants (PWD) That Prefer One Device Over the Other | Strongly Prefer Nasal Glucagon | 78.1 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (PWD) That Prefer One Device Over the Other | Prefer Nasal Glucagon | 12.5 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (PWD) That Prefer One Device Over the Other | No Preference | 3.1 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (PWD) That Prefer One Device Over the Other | Prefer Injectable Glucagon | 0.0 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (PWD) That Prefer One Device Over the Other | Strongly Prefer Injectable Glucagon | 6.3 percentage of participants |
Secondary
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.
Time frame: Part A: Days 15 -17 and Part B: Days 8 - 9
Population: All trained and untrained users who found both devices and completed the device preference questionnaires. PWD reporting group data not collected per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nasal Glucagon (NG) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Prefer Nasal Glucagon | 29.0 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Prefer Injectable Glucagon | 6.5 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | No Preference | 9.7 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Strongly Prefer Injectable Glucagon | 3.2 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Strongly Prefer Nasal Glucagon | 48.4 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Strongly Prefer Injectable Glucagon | 3.2 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Strongly Prefer Nasal Glucagon | 80.6 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Prefer Nasal Glucagon | 16.1 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | No Preference | 0.0 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other | Prefer Injectable Glucagon | 0.0 percentage of participants |
Secondary
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.
Time frame: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
Population: All trained and untrained participants who found both devices and completed the rescue device preference questionnaire for Part A and Part B combined. PWD reporting group data not collected per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nasal Glucagon (NG) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Prefer Nasal Glucagon | 22.6 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Prefer Injectable Glucagon | 6.5 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | No Preference | 6.5 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Strongly Prefer Injectable Glucagon | 6.5 percentage of participants |
| Nasal Glucagon (NG) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Strongly Prefer Nasal Glucagon | 58.1 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Strongly Prefer Injectable Glucagon | 3.2 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Strongly Prefer Nasal Glucagon | 71.0 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Prefer Nasal Glucagon | 22.6 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | No Preference | 3.2 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other | Prefer Injectable Glucagon | 0.0 percentage of participants |
Secondary
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.
Time frame: Part B: Day 1 and Days 8-9
Population: All untrained user participants who found both devices and participated in at least one simulation of a rescue device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasal Glucagon (NG) | Percentage of Untrained Users That Perform a Successful Administration for Each Device | 90.9 percentage of participants |
| Glucagon Emergency Kit (GEK) | Percentage of Untrained Users That Perform a Successful Administration for Each Device | 0 percentage of participants |
p-value: <0.0001McNemar