Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT03765502
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03765502
Study Brief:
Protocol Section:
NCT03765502