Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT03765502
Status:
COMPLETED
Last Update Posted:
2020-03-20
First Post:
2018-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Comparing User Experience of Different Delivery Devices for Glucagon
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to end of study (up to 17 days)', 'description': 'All participants who participated in at least one training or simulation of a study device.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A Trained Users Nasal Glucagon (NG)', 'description': 'Trained users NG.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A Trained Users Glucagon Emergency Kit (GEK)', 'description': 'Trained user GEK.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A Participants With Diabetes (PWD)', 'description': 'PWD', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part B Untrained Users NG', 'description': 'Untrained user NG.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B Untrained Users GEK', 'description': 'Untrained user GEK.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Trained Users That Performed a Successful Administration for Each Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Glucagon (NG)', 'description': 'Trained participants who found and had a successful administration of NG rescue device.'}, {'id': 'OG001', 'title': 'Glucagon Emergency Kit (GEK)', 'description': 'Trained participants who found had a successful administration of the GEK rescue device.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Crossover design: paired test'}], 'paramType': 'NUMBER', 'timeFrame': 'Part A: Days 8 - 9 and Days 15 - 17', 'description': 'Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Untrained Users That Perform a Successful Administration for Each Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Glucagon (NG)', 'description': 'Participants who were not trained on the administration of NG rescue device.'}, {'id': 'OG001', 'title': 'Glucagon Emergency Kit (GEK)', 'description': 'Participants who were not trained on the administration of the GEK.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Crossover design: paired test'}], 'paramType': 'NUMBER', 'timeFrame': 'Part B: Day 1 and Days 8-9', 'description': 'Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All untrained user participants who found both devices and participated in at least one simulation of a rescue device.'}, {'type': 'SECONDARY', 'title': 'Average Time for Trained Users to Successfully Administer One Device Over the Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Glucagon (NG)', 'description': 'Trained participants who found device and had a successful administration of NG rescue device.'}, {'id': 'OG001', 'title': 'Glucagon Emergency Kit (GEK)', 'description': 'Trained participants who found device and had a successful administration of GEK rescue device.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '52.0', 'groupId': 'OG000'}, {'value': '81.8', 'spread': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part A: Day 8 and Days 15-17', 'description': 'Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All trained user participants who found both devices and completed at least one device simulation. PWD reporting group data not collected per protocol.'}, {'type': 'SECONDARY', 'title': 'Average Time for Untrained Users to Successfully Administer One Device Over the Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Glucagon Device (NG)', 'description': 'Untrained participants who found device and had a successful administration of NG rescue device.'}, {'id': 'OG001', 'title': 'Glucagon Emergency Kit (GEK)', 'description': 'Untrained participants who found device and had a successful administration of GEK rescue device.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '47.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were no successful administrations of the Glucagon Emergency Kit for the untrained participants. Data for average time of unsuccessful administrations were not collected.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part B: Day 1 and Days 8-9', '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.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All untrained user participants who found both devices and completed at least one successful rescue device simulation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A (Trained)', 'description': 'Overall preference for Trained users (Part A) for rescue device, NG and GEK.'}, {'id': 'OG001', 'title': 'Part B (Untrained)', 'description': 'Overall preference for Untrained users (Part B) for rescue device, NG and GEK.'}], 'classes': [{'title': 'Strongly Prefer Nasal Glucagon', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}]}]}, {'title': 'Prefer Nasal Glucagon', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Prefer Injectable Glucagon', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Strongly Prefer Injectable Glucagon', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (PWD) That Prefer One Device Over the Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant With Diabetes (PWD)', '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.'}], 'classes': [{'title': 'Strongly Prefer Nasal Glucagon', 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000'}]}]}, {'title': 'Prefer Nasal Glucagon', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Prefer Injectable Glucagon', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Strongly Prefer Injectable Glucagon', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part A: Days 15 - 17', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All PWD who completed the device preference questionnaire.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A (Trained)', 'description': 'Overall ease of use for Trained users (Part A) for rescue device, NG and GEK.'}, {'id': 'OG001', 'title': 'Part B (Untrained)', 'description': 'Overall ease of use for Untrained users (Part B) for rescue device, NG and GEK.'}], 'classes': [{'title': 'Strongly Prefer Nasal Glucagon', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '80.6', 'groupId': 'OG001'}]}]}, {'title': 'Prefer Nasal Glucagon', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Prefer Injectable Glucagon', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Strongly Prefer Injectable Glucagon', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part A: Days 15 -17 and Part B: Days 8 - 9', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All trained and untrained users who found both devices and completed the device preference questionnaires. PWD reporting group data not collected per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A Trained Users NG/GEK', 'description': 'Simulation 1: Day 8 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.\n\nSimulation 2: Day 15 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.\n\nNo drug was administered to humans in either simulation.'}, {'id': 'FG001', 'title': 'Part A Trained Users GEK/NG', 'description': 'Simulation 1: Day 8 participants were trained to administer a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.\n\nSimulation 2: Day 15 participants were trained to administer an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.\n\nNo drug was administered to humans in either simulation.'}, {'id': 'FG002', 'title': 'Part A Person With Diabetes (PWD)', 'description': 'Day 1 - PWD trained participants to administer a glucose emergency kit intramuscularly or an empty nasal glucagon device (depending on randomization).\n\nSimulation 1: Day 8 - PWD trained participants to administer an empty nasal glucagon device or a glucose emergency kit intramuscularly(depending on randomization).\n\nNo drug was administered to humans in either simulation.'}, {'id': 'FG003', 'title': 'Part B Untrained Users NG/GEK', 'description': 'Simulation1: Day 1 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.\n\nSimulations 2: Day 8 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.\n\nNo drug was administered to humans in either simulation.'}, {'id': 'FG004', 'title': 'Part B Untrained Users GEK/NG', 'description': 'Simulation 1: Day 1 untrained participants administered a glucose emergency kit intramuscularly to a manikin during a simulation of severe hypoglycemia emergency.\n\nSimulation 2: Day 8 untrained participants administered an empty nasal glucagon device to a manikin during a simulation of severe hypoglycemia emergency.\n\nNo drug was administered to humans in either simulation.'}], 'periods': [{'title': 'Simulation 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Simulation 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'comment': 'Participant completed Period 1 GEK simulation but did not return for the Period 2 NG simulation.', 'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'PWD completed Period 1 GEK simulation but did not return for the Period 2 NG simulation.', 'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Trained users participated in Part A and untrained users participated in Part B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A Trained Users', 'description': 'All trained participants in Part A'}, {'id': 'BG001', 'title': 'Part A Participants With Diabetes', 'description': 'All participants with diabetes in Part A'}, {'id': 'BG002', 'title': 'Part B Untrained Users', 'description': 'All participants in Part B.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized trained user participants, untrained user participants, and participants with diabetes.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-19', 'size': 465634, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-08T09:00', 'hasProtocol': False}, {'date': '2018-12-06', 'size': 606131, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-08T09:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2018-11-16', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-06', 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Trained Users That Performed a Successful Administration for Each Device', 'timeFrame': 'Part A: Days 8 - 9 and Days 15 - 17', 'description': 'Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Untrained Users That Perform a Successful Administration for Each Device', 'timeFrame': 'Part B: Day 1 and Days 8-9', 'description': 'Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.'}, {'measure': 'Average Time for Trained Users to Successfully Administer One Device Over the Other', 'timeFrame': 'Part A: Day 8 and Days 15-17', 'description': 'Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.'}, {'measure': 'Average Time for Untrained Users to Successfully Administer One Device Over the Other', 'timeFrame': 'Part B: Day 1 and Days 8-9', '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.'}, {'measure': 'Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other', 'timeFrame': 'Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9', '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.'}, {'measure': 'Percentage of Participants (PWD) That Prefer One Device Over the Other', 'timeFrame': 'Part A: Days 15 - 17', '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.'}, {'measure': 'Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other', 'timeFrame': 'Part A: Days 15 -17 and Part B: Days 8 - 9', '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants (Trained Users, Participants with Diabetes \\[PWDs\\] and Untrained Users):\n\n* 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\n\nTrained Users only:\n\n* Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)\n* Are close friends/relatives of a patient with T1DM or T2DM on insulin\n* Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)\n\nUntrained Users only:\n\n* Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with T1DM or T2DM\n* Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)\n\nExclusion Criteria:\n\nAll participants (Trained Users, PWDs and Untrained Users):\n\n* In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study\n\nTrained Users and Untrained Users only (i.e. the participants involved in the simulations):\n\n* Are currently enrolled in a clinical study involving any type of medical research judged not to be scientifically or medically compatible with this study\n* Are judged by the investigator as being likely to have difficulty performing the administration due to physical, cognitive and/or severe psychiatric disorder\n* Are judged by the investigator as being trained or experienced in performing rescue drug administration\n* Are judged by the investigator as being trained or experienced in performing high-fidelity simulations of drug administration\n* 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'}, 'identificationModule': {'nctId': 'NCT03765502', 'briefTitle': 'A Study Comparing User Experience of Different Delivery Devices for Glucagon', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon', 'orgStudyIdInfo': {'id': '17156'}, 'secondaryIdInfos': [{'id': 'I8R-MC-IGBM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal Glucagon Device (NG)', 'description': 'Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.', 'interventionNames': ['Device: Nasal Glucagon Device (NG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucagon Emergency Kit (GEK)', 'description': 'Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.', 'interventionNames': ['Device: GEK', 'Drug: IM Glucagon']}], 'interventions': [{'name': 'Nasal Glucagon Device (NG)', 'type': 'DEVICE', 'description': 'NG devices will be provided empty of drug product', 'armGroupLabels': ['Nasal Glucagon Device (NG)']}, {'name': 'GEK', 'type': 'DEVICE', 'description': 'Used to administer glucagon intramuscularly (IM)', 'armGroupLabels': ['Glucagon Emergency Kit (GEK)']}, {'name': 'IM Glucagon', 'type': 'DRUG', 'description': 'Administered IM via GEK', 'armGroupLabels': ['Glucagon Emergency Kit (GEK)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27265', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'High Point Clinical Trials Center', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}], 'overallOfficials': [{'name': '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)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}