Primary outcomeNumber· Part A: Days 8 - 9 and Days 15 - 17
Percentage of Trained Users That Performed a Successful Administration for Each Device
| Group | Value (percentage of participants) |
|---|---|
| Nasal Glucagon (NG) | 90.3 |
| Glucagon Emergency Kit (GEK) | 15.6 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataA Study Comparing User Experience of Different Delivery Devices for Glucagon
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 99 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 19 Nov 2018
- Primary completion
- 3 Jan 2019
- Completion
- 3 Jan 2019
- First posted
- 5 Dec 2018
- Last update posted
- 20 Mar 2020
- Conditions
- Healthy
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201820192020
- Ph 1
A Study Comparing User Experience of Different Delivery Devices for Glucagon
NCT0376550219 Nov 2018 to 3 Jan 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- Nasal Glucagon Device (NG)Device
- GEKDevice
- IM GlucagonDrug
Arms2
Experimental
Nasal Glucagon Device (NG)
Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
Active comparator
Glucagon Emergency Kit (GEK)
Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Trained Users That Performed a Successful Administration for Each Device
Time frame · Part A: Days 8 - 9 and Days 15 - 17
Registry description
Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Secondary outcomes(6)
Percentage of Untrained Users That Perform a Successful Administration for Each Device
Time frame · Part B: Day 1 and Days 8-9
Registry description
Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Average Time for Trained Users to Successfully Administer One Device Over the Other
Time frame · Part A: Day 8 and Days 15-17
Registry description
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
Time frame · Part B: Day 1 and Days 8-9
Registry description
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 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
Registry description
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.
Percentage of Participants (PWD) That Prefer One Device Over the Other
Time frame · Part A: Days 15 - 17
Registry description
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
Time frame · Part A: Days 15 -17 and Part B: Days 8 - 9
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeNumber· Part B: Day 1 and Days 8-9
Percentage of Untrained Users That Perform a Successful Administration for Each Device
| Group | Value (percentage of participants) |
|---|---|
| Nasal Glucagon (NG) | 90.9 |
| Glucagon Emergency Kit (GEK) | 0 |
Secondary outcomeMean· Part A: Day 8 and Days 15-17
Average Time for Trained Users to Successfully Administer One Device Over the Other
| Group | Value (seconds) | Spread |
|---|---|---|
| Nasal Glucagon (NG) | 47.3 | 52.0 |
| Glucagon Emergency Kit (GEK) | 81.8 | 18.6 |
Secondary outcomeMean· Part B: Day 1 and Days 8-9
Average Time for Untrained Users to Successfully Administer One Device Over the Other
| Group | Value (seconds) | Spread |
|---|---|---|
| Nasal Glucagon Device (NG) | 44.5 | 47.8 |
| Glucagon Emergency Kit (GEK) | NA | NA |
Secondary outcomeNumber· Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other
| Group | Value (percentage of participants) |
|---|---|
| Part A (Trained) | 58.1 |
| Part B (Untrained) | 71.0 |
Secondary outcomeNumber· Part A: Days 15 - 17
Percentage of Participants (PWD) That Prefer One Device Over the Other
| Group | Value (percentage of participants) |
|---|---|
| Participant With Diabetes (PWD) | 78.1 |
Secondary outcomeNumber· Part A: Days 15 -17 and Part B: Days 8 - 9
Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other
| Group | Value (percentage of participants) |
|---|---|
| Part A (Trained) | 48.4 |
| Part B (Untrained) | 80.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Part A Trained Users Nasal Glucagon (NG)Trained users NG. | 0 / 33 | 0 / 33 | 0 / 33 |
| Part A Trained Users Glucagon Emergency Kit (GEK)Trained user GEK. | 0 / 32 | 0 / 32 | 0 / 32 |
| Part A Participants With Diabetes (PWD)PWD | 0 / 33 | 0 / 33 | 0 / 33 |
| Part B Untrained Users NGUntrained user NG. | 0 / 33 | 0 / 33 | 0 / 33 |
| Part B Untrained Users GEKUntrained user GEK. | 0 / 33 | 0 / 33 | 0 / 33 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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