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)

NCT ID: NCT05395000

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2022-09-22

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.

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Parents" group

Parent or primary caregiver of a child or adolescent (\<18 years old) diagnosed with type 1 diabetes.

Group Type: EXPERIMENTAL

Videos

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

An intranasal and injectable glucagon administration test on a mannequin in a simulated stress environment will be done.

Interview

Intervention Type: BEHAVIORAL

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.

"School workers" group

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.

Group Type: EXPERIMENTAL

Videos

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

An intranasal and injectable glucagon administration test on a mannequin in a simulated stress environment will be done.

Interview

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Simulation

An intranasal and injectable glucagon administration test on a mannequin in a simulated stress environment will be done.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Claudia Gagnon

Principal Investigator, Endocrinologist, Regular Researcher of the Endocrinology-Nephrology Axis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Gagnon, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec - Université Laval

Locations

Centre de recherche du CHU de Québec - Université Laval

Québec, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37751153 (View on PubMed)

Other Identifiers

2021-5626

Identifier Type: -

Identifier Source: org_study_id