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)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1; Hypoglycemia
• Interventions: Behavioral: Videos; Behavioral: Simulation; Behavioral: Interview

• Registration Number: NCT05395000
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-19
• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-05-27
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
"Parents" group	Videos	Parent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes.
"School workers" group	Simulation	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, facilitators, teacher candidates, etc.). This individual must not meet the criteria for the "parent" group.
"Parents" group	Interview	Parent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes.
"Parents" group	Simulation	Parent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes.
"School workers" group	Interview	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, facilitators, teacher candidates, etc.). This individual must not meet the criteria for the "parent" group.
"School workers" group	Videos	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, facilitators, teacher candidates, etc.). This individual must not meet the criteria for the "parent" group.

Primary Outcome Measures

Name	Time	Method
Success rate of glucagon administration	through the simulation completion, 3 months after listening to the videos	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
Time to complete preparation and administration of the glucagon	through the simulation completion, 3 months after listening to the videos	As an indicator to compare the performance of the intranasal glucagon and injectable glucagon procedures

Secondary Outcome Measures

Name	Time	Method
Emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups	through the interview completion, 3 months after listening to the videos	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
Barriers related to the use of intranasal and injectable glucagon in both groups	through the interview completion, 3 months after listening to the videos	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
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
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

Trial Locations

Locations (1)

Centre de recherche du CHU de Québec - Université Laval; 🇨🇦 Québec, Canada