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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBM | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Glucagon Device (NG) | Experimental | Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans. |
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| Glucagon Emergency Kit (GEK) | Active Comparator | Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon Device (NG) | Device | NG devices will be provided empty of drug product |
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| 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 |
| 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 |
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Inclusion Criteria:
All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):
Trained Users only:
Untrained Users only:
Exclusion Criteria:
All participants (Trained Users, PWDs and Untrained Users):
Trained Users and Untrained Users only (i.e. the participants involved in the simulations):
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
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Trained users participated in Part A and untrained users participated in Part B.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Trained Users NG/GEK | Simulation 1: Day 8 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency. Simulation 2: Day 15 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency. No drug was administered to humans in either simulation. |
| FG001 | Part A Trained Users GEK/NG | Simulation 1: Day 8 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency. Simulation 2: Day 15 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency. No drug was administered to humans in either simulation. |
| FG002 | Part A Person With Diabetes (PWD) | Day 1 - PWD trained participants to administer a glucose emergency kit intramuscularly or an empty nasal glucagon device (depending on randomization). Simulation 1: Day 8 - PWD trained participants to administer an empty nasal glucagon device or a glucose emergency kit intramuscularly(depending on randomization). No drug was administered to humans in either simulation. |
| FG003 | Part B Untrained Users NG/GEK | Simulation1: Day 1 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency. Simulations 2: Day 8 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency. No drug was administered to humans in either simulation. |
| FG004 | Part B Untrained Users GEK/NG | Simulation 1: Day 1 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency. Simulation 2: Day 8 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency. No drug was administered to humans in either simulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Simulation 1 |
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| Simulation 2 |
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All randomized trained user participants, untrained user participants, and participants with diabetes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Trained Users | All trained participants in Part A |
| BG001 | Part A Participants With Diabetes | All participants with diabetes in Part A |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants | Part A: Days 8 - 9 and Days 15 - 17 |
|
Baseline to end of study (up to 17 days)
All participants who participated in at least one training or simulation of a study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Trained Users Nasal Glucagon (NG) | Trained users NG. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2018 | Oct 8, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 6, 2018 | Oct 8, 2019 | Prot_001.pdf |
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| GEK | Device | Used to administer glucagon intramuscularly (IM) |
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| IM Glucagon | Drug | Administered IM via GEK |
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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 |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Part B Untrained Users | All participants in Part B. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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Trained participants who found had a successful administration of the GEK rescue device.
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| 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. | All untrained user participants who found both devices and participated in at least one simulation of a rescue device. | Posted | Number | percentage of participants | Part B: Day 1 and Days 8-9 |
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| 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. | All trained user participants who found both devices and completed at least one device simulation. PWD reporting group data not collected per protocol. | Posted | Mean | Standard Deviation | seconds | Part A: Day 8 and Days 15-17 |
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| 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. | All untrained user participants who found both devices and completed at least one successful rescue device simulation. | Posted | Mean | Standard Deviation | seconds | Part B: Day 1 and Days 8-9 |
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| 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. | 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. | Posted | Number | percentage of participants | Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9 |
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| 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. | All PWD who completed the device preference questionnaire. | Posted | Number | percentage of participants | Part A: Days 15 - 17 |
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| 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. | All trained and untrained users who found both devices and completed the device preference questionnaires. PWD reporting group data not collected per protocol. | Posted | Number | percentage of participants | Part A: Days 15 -17 and Part B: Days 8 - 9 |
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| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Part A Trained Users Glucagon Emergency Kit (GEK) | Trained user GEK. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | Part A Participants With Diabetes (PWD) | PWD | 0 | 33 | 0 | 33 | 0 | 33 |
| EG003 | Part B Untrained Users NG | Untrained user NG. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG004 | Part B Untrained Users GEK | Untrained user GEK. | 0 | 33 | 0 | 33 | 0 | 33 |
The sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The agreement also provides that if CRU is unwilling to delay the publication or presentation, CRU will remove the information which sponsor has specified it reasonably believes would jeopardize its intellectual property interests.
| No Preference |
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| Prefer Injectable Glucagon |
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| Strongly Prefer Injectable Glucagon |
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| Title | Measurements |
|---|---|
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| Prefer Injectable Glucagon |
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| Strongly Prefer Injectable Glucagon |
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| No Preference |
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| Prefer Injectable Glucagon |
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| Strongly Prefer Injectable Glucagon |
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