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Diabetes Mellitus, Type 1NCT05395000

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)

A study testing Videos, Simulation and Interview in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 1, Hypoglycemia
What is being tested?
Videos, Simulation and Interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
19 Mar 2021to 22 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de recherche du CHU de Québec - Université Laval

    Québec, G1V 4G2

Other trials in Canada

About this study

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

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.

Read more

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.
Being tested
Videos, Simulation, Interview
Keywords
injectable glucagon, intranasal glucagon
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VideosBehavioural

    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.

  • SimulationBehavioural

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

  • InterviewBehavioural

    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.

Study groups in NCT05395000
Study groupRoleWhat they receive
"Parents" groupExperimentalParent or primary caregiver of a child or adolescent (<18 years old) diagnosed with type 1 diabetes.
Receives: Behavioral: Videos; Behavioral: Simulation; Behavioral: Interview
"School workers" groupExperimentalAny 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.
Receives: Behavioral: Videos; Behavioral: Simulation; Behavioral: Interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to complete preparation and administration of the glucagon

    As an indicator to compare the performance of the intranasal glucagon and injectable glucagon procedures

    Measured: through the simulation completion, 3 months after listening to the videos

  2. 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

    Measured: through the simulation completion, 3 months after listening to the videos

Secondary outcomes (4)

  1. Preferences of the administration procedure for the two glucagon formulations in the two groups

    Measured: through the interview completion, 3 months after listening to the videos

  2. 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

    Measured: through the interview completion, 3 months after listening to the videos

  3. 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

    Measured: through the interview completion, 3 months after listening to the videos

  4. Preferences in relation to the teaching method of administering the two forms of glucagon

    Measured: through the interview completion, 3 months after listening to the videos

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start19 Mar 2021
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395000
Sponsor's protocol ID
2021-5626
Status last verified
Feb 2023
First submitted
29 Apr 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37751153

Questions about this trial

What is this clinical trial studying?

A study testing Videos, Simulation and Interview in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to complete preparation and administration of the glucagon (time frame: through the simulation completion, 3 months after listening to the videos). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05395000, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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