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)

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395000
• Other study ID #: 2021-5626
• Status: Completed
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: February 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Behavioral:
• Videos
A short video explaining briefly what type 1 diabetes is, the symptoms of hypoglycemia and the usefulness of glucagon as well as two short videos explaining how to administer glucagon, all less than 3 minutes long, will be viewed by the 2 groups for intranasal glucagon and injectable glucagon. Participants will have access to the videos for 2 weeks, approximately 3 months before the next stages of the project.
• Simulation
An intranasal and injectable glucagon administration test on a mannequin in a simulated stress environment will be done.
• Interview
At the end of the simulation, participants will participate in a semi-structured, recorded individual interview of approximately 20 minutes to share their experience related to preferences, barriers, emotional impact, and method of teaching the use of the two glucagon formulations.

Locations

Country	Name	City	State
Canada	Centre de recherche du CHU de Québec - Université Laval	Québec

Sponsors (3)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Institutes of Health Research (CIHR), Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete preparation and administration of the glucagon	As an indicator to compare the performance of the intranasal glucagon and injectable glucagon procedures	through the simulation completion, 3 months after listening to the videos
Primary	Success rate of glucagon administration	As an indicator to compare the performance of the intranasal glucagon and injectable glucagon procedures.; Success is defined as completion of at least 80% of the key steps, including 100% of the "critical" steps	through the simulation completion, 3 months after listening to the videos
Secondary	Preferences of the administration procedure for the two glucagon formulations in the two groups		through the interview completion, 3 months after listening to the videos
Secondary	Barriers related to the use of intranasal and injectable glucagon in both groups	The barriers and emotional impact raised by the participants will be classified using the theoretical domains framework (TDF), which is a validated theoretical framework composed of 14 modifiable domains that allows for the assessment of barriers to the implementation of a behavior change and facilitates the development of solution paths afterwards	through the interview completion, 3 months after listening to the videos
Secondary	Emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups	The barriers and emotional impact raised by the participants will be classified using the theoretical domains framework (TDF), which is a validated theoretical framework composed of 14 modifiable domains that allows for the assessment of barriers to the implementation of a behavior change and facilitates the development of solution paths afterwards	through the interview completion, 3 months after listening to the videos
Secondary	Preferences in relation to the teaching method of administering the two forms of glucagon		through the interview completion, 3 months after listening to the videos