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)
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2021
CompletedFirst Submitted
Initial submission to the registry
April 29, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2022
CompletedFebruary 8, 2023
February 1, 2023
1.5 years
April 29, 2022
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (4)
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
Barriers related to the use of intranasal and injectable glucagon in both groups
through the interview completion, 3 months after listening to the videos
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
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
Study Arms (2)
"Parents" group
EXPERIMENTALParent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes.
"School workers" group
EXPERIMENTALAny 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.
Interventions
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.
An intranasal and injectable glucagon administration test on a mannequin in a simulated stress environment will be done.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Working in the health field and teach glucagon injection or use it regularly in their duties
- Not understanding French (for viewing the videos)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Quebec-Universite Lavallead
- Canadian Institutes of Health Research (CIHR)collaborator
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (1)
Centre de recherche du CHU de Québec - Université Laval
Québec, G1V 4G2, Canada
Related Publications (1)
Wang YP, Bernatchez F, Chouinard-Castonguay S, Tremblay MC, Vanasse A, Kinnard N, Megalli M, Millette M, Boulet G, Henderson M, Simoneau-Roy J, Brazeau AS, Rabasa-Lhoret R, Gagnon C. Comparison of Intranasal and Injectable Glucagon Administration Among Pediatric Population Responders. Diabetes Technol Ther. 2023 Nov;25(11):808-816. doi: 10.1089/dia.2023.0290.
PMID: 37751153DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Gagnon, Dr
CHU de Québec - Université Laval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Endocrinologist, Regular Researcher of the Endocrinology-Nephrology Axis
Study Record Dates
First Submitted
April 29, 2022
First Posted
May 27, 2022
Study Start
March 19, 2021
Primary Completion
September 22, 2022
Study Completion
September 22, 2022
Last Updated
February 8, 2023
Record last verified: 2023-02