A Study Comparing User Experience of Different Delivery Devices for Glucagon

What Was Tested

In this phase 1 trial, researchers set out to test Glucagon.

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.

It had two arms (groups): Nasal Glucagon Device (NG) (experimental) and Glucagon Emergency Kit (GEK) (active comparator).

Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

The registry classes the interventions as device and drug.

Who Took Part

99 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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. 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). Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with T1DM or T2DM.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-11-19 with completion listed for 2019-01-03.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Percentage of Trained Users That Performed a Successful Administration for Each Device (time frame: Part A: Days 8 - 9 and Days 15 - 17).

It also tracked 6 secondary outcomes, for example Percentage of Untrained Users That Perform a Successful Administration for Each Device, Average Time for Trained Users to Successfully Administer One Device Over the Other, Average Time for Untrained Users to Successfully Administer One Device Over the Other, Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other, Percentage of Participants (PWD) That Prefer One Device Over the Other and Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 99 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glucagon compound page, all human trials.