Comparison of Ease of Use and Acceptability of Intranasal and Injectable Glucagon Among Providers Administering it to Children or Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Success rate of glucagon administration
研究概览
简要总结
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 :
- To assess stakeholder administration procedure preferences for the two glucagon formulations in the two groups ;
- To explore the barriers and emotional impact (fears, perceptions, stress, etc.) related to the use of intranasal and injectable glucagon in both groups;
- Explore the participants' preferences in relation to the teaching method of administering the two forms of glucagon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Working in the health field and teach glucagon injection or use it regularly in their duties
- •Not understanding French (for viewing the videos)
结局指标
主要结局
Success rate of glucagon administration
时间窗: 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
时间窗: 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
次要结局
- 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)
- Barriers related to the use of intranasal and injectable glucagon in both groups(through the interview completion, 3 months after listening to the videos)
- 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)
研究者
Claudia Gagnon
Principal Investigator, Endocrinologist, Regular Researcher of the Endocrinology-Nephrology Axis
CHU de Quebec-Universite Laval