Clinical trial NCT05395000: Comparison of Ease of Use and Acceptability of Intranasal and Injectable Glucagon Among Providers Administering it to Children or Adolescents With Type 1 Diabetes (BETTER-ING)
Official title: Comparison of Ease of Use and Acceptability of Intranasal and Injectable Glucagon Among Providers Administering it to Children or Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Hypoglycemia
Keywords: injectable glucagon
intranasal glucagon
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Juvenile Diabetes Research Foundation
First posted: 2022-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Half of the participants will perform the simulation study with the intranasal device first and the other half with the injectable glucagon to minimize the bias related to the lower stress of the second simulation.
Primary purpose: TREATMENT

Brief summary: Background : The benefits of good glycemic control are clearly established. However, achieving glycemic targets comes at the expense of the risk of hypoglycemia. Repeated episodes of severe hypoglycemia can affect long-term cognitive function, especially in developing brains. Fear of hypoglycemia, both in children and their parents, has an impact on participation in physical activity, quality of life and optimal diabetes control. During an episode of severe hypoglycemia, i.e., when accompanied by severe cognitive dysfunction requiring assistance from others, it is impossible to administer oral glucose. Glucagon administration is particularly useful in this situation, as it rapidly raises blood glucose levels and restores consciousness. Injectable glucagon was the only form approved in Canada prior to 2019. A new formulation of glucagon for intranasal administration has recently been approved by Health Canada. The arrival of this formulation seems promising because of its ease of use while ensuring similar efficacy to injectable glucagon. Furthermore, the ease of learning how to use each of the devices through a simple multimedia tool is unknown. Indeed, current studies have not focused on a virtual teaching method. The latter is of particular interest in the context of a pandemic and in order to make information more accessible to a broader population that may not be present at family glucagon education (e.g., school-based caregivers).

Objective : Compare the performance (time to prepare and administer, success rate) of the intranasal versus injectable glucagon administration procedure after a short video training 3 months earlier among parents/primary caregivers and school workers who may administer glucagon to children with type 1 diabetes.

Secondary objectives :

1. To assess stakeholder administration procedure preferences for the two glucagon formulations in the two groups ;
2. To explore the barriers and emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups;
3. Explore the participants' preferences in relation to the teaching method of administering the two forms of glucagon.


Eligibility criteria: Inclusion Criteria:

* Parent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes OR
* Any adult who works or will work in a school or daycare setting who is likely to administer glucagon to a child or adolescent with type 1 diabetes (e.g. teachers, animators, teacher candidates, etc.) AND
* Legal age
* Able to participate

Exclusion Criteria:

* Working in the health field and teach glucagon injection or use it regularly in their duties
* Not understanding French (for viewing the videos)

Primary outcomes:
measure: Time to complete preparation and administration of the glucagon
timeFrame: through the simulation completion, 3 months after listening to the videos
measure: Success rate of glucagon administration
timeFrame: through the simulation completion, 3 months after listening to the videos
Secondary outcomes:
measure: Preferences of the administration procedure for the two glucagon formulations in the two groups
timeFrame: through the interview completion, 3 months after listening to the videos
measure: Barriers related to the use of intranasal and injectable glucagon in both groups
timeFrame: through the interview completion, 3 months after listening to the videos
measure: Emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups
timeFrame: through the interview completion, 3 months after listening to the videos
measure: Preferences in relation to the teaching method of administering the two forms of glucagon
timeFrame: through the interview completion, 3 months after listening to the videos
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche du CHU de Québec - Université Laval
Study officials:
affiliation: CHU de Québec - Université Laval
name: Claudia Gagnon, Dr
role: PRINCIPAL_INVESTIGATOR
References: