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A Study Comparing User Experience of Different Delivery Devices for Glucagon

NCT03765502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-03-20

Study results available
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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.

Conditions

  • Healthy

Interventions

DEVICE

Nasal Glucagon Device (NG)

NG devices will be provided empty of drug product

DEVICE

GEK

Used to administer glucagon intramuscularly (IM)

DRUG

IM Glucagon

Administered IM via GEK

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2019-01-03
Completion
2019-01-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765502 on ClinicalTrials.gov