Trial Outcomes & Findings for A Study Comparing User Experience of Different Delivery Devices for Glucagon (NCT NCT03765502)

Last Updated: 2020-03-20

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

99 participants

Primary outcome timeframe

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

Results posted on

2020-03-20

Participant Flow

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.

Trained users participated in Part A and untrained users participated in Part B.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Simulation 1 STARTED	20	13	33	16	17
Simulation 1 COMPLETED	20	13	33	16	17
Simulation 1 NOT COMPLETED	0	0	0	0	0
Simulation 2 STARTED	20	12	32	16	17
Simulation 2 COMPLETED	20	12	32	16	17
Simulation 2 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing User Experience of Different Delivery Devices for Glucagon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Trained Users n=33 Participants All trained participants in Part A	Part A Participants With Diabetes n=33 Participants All participants with diabetes in Part A	Part B Untrained Users n=33 Participants All participants in Part B.	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	32 Participants n=7 Participants	33 Participants n=5 Participants	94 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	60 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	33 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants	99 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=31 Participants Trained participants who found and had a successful administration of NG rescue device.	Glucagon Emergency Kit (GEK) n=32 Participants Trained participants who found had a successful administration of the GEK rescue device.
Percentage of Trained Users That Performed a Successful Administration for Each Device	90.3 percentage of participants	15.6 percentage of participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=33 Participants Trained participants who found and had a successful administration of NG rescue device.	Glucagon Emergency Kit (GEK) n=31 Participants Trained participants who found had a successful administration of the GEK rescue device.
Percentage of Untrained Users That Perform a Successful Administration for Each Device	90.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=28 Participants Trained participants who found and had a successful administration of NG rescue device.	Glucagon Emergency Kit (GEK) n=32 Participants Trained participants who found had a successful administration of the GEK rescue device.
Average Time for Trained Users to Successfully Administer One Device Over the Other	47.3 seconds Standard Deviation 52.0	81.8 seconds Standard Deviation 18.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=30 Participants Trained participants who found and had a successful administration of NG rescue device.	Glucagon Emergency Kit (GEK) n=33 Participants Trained participants who found had a successful administration of the GEK rescue device.
Average Time for Untrained Users to Successfully Administer One Device Over the Other	44.5 seconds Standard Deviation 47.8	NA seconds Standard Deviation NA There were no successful administrations of the Glucagon Emergency Kit for the untrained participants. Data for average time of unsuccessful administrations were not collected.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=31 Participants Trained participants who found and had a successful administration of NG rescue device.	Glucagon Emergency Kit (GEK) n=31 Participants Trained participants who found had a successful administration of the GEK rescue device.
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other Strongly Prefer Nasal Glucagon	58.1 percentage of participants	71.0 percentage of participants
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other Prefer Nasal Glucagon	22.6 percentage of participants	22.6 percentage of participants
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other No Preference	6.5 percentage of participants	3.2 percentage of participants
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other Prefer Injectable Glucagon	6.5 percentage of participants	0.0 percentage of participants
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other Strongly Prefer Injectable Glucagon	6.5 percentage of participants	3.2 percentage of participants

SECONDARY outcome

Timeframe: Part A: Days 15 - 17

Population: All PWD who completed the device preference questionnaire.

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.

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=32 Participants Trained participants who found and had a successful administration of NG rescue device.	Glucagon Emergency Kit (GEK) Trained participants who found had a successful administration of the GEK rescue device.
Percentage of Participants (PWD) That Prefer One Device Over the Other Strongly Prefer Nasal Glucagon	78.1 percentage of participants	—
Percentage of Participants (PWD) That Prefer One Device Over the Other Prefer Nasal Glucagon	12.5 percentage of participants	—
Percentage of Participants (PWD) That Prefer One Device Over the Other No Preference	3.1 percentage of participants	—
Percentage of Participants (PWD) That Prefer One Device Over the Other Prefer Injectable Glucagon	0.0 percentage of participants	—
Percentage of Participants (PWD) That Prefer One Device Over the Other Strongly Prefer Injectable Glucagon	6.3 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

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.