A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percentage of Trained Users That Performed a Successful Administration for Each Device
研究概览
简要总结
The purpose of the study is to learn more about different devices for delivering glucagon during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be carried out using medical manikins to simulate real life scenarios. No drug will be administered to humans. Part A will last approximately 17 days for Trained Users and Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained Users. Each part will be separated by approximately 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):
- •Are able to understand the purpose and procedure of the study and to give written informed consent to show willingness to participate in the study
- •Trained Users only:
- •Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
- •Are close friends/relatives of a patient with T1DM or T2DM on insulin
- •Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)
- •Untrained Users only:
- •Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with T1DM or T2DM
- •Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)
排除标准
- •All participants (Trained Users, PWDs and Untrained Users):
- •In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
- •Trained Users and Untrained Users only (i.e. the participants involved in the simulations):
- •Are currently enrolled in a clinical study involving any type of medical research judged not to be scientifically or medically compatible with this study
- •Are judged by the investigator as being likely to have difficulty performing the administration due to physical, cognitive and/or severe psychiatric disorder
- •Are judged by the investigator as being trained or experienced in performing rescue drug administration
- •Are judged by the investigator as being trained or experienced in performing high-fidelity simulations of drug administration
- •Have received formal training in a medical field, and/or worked in this field within the prior 5 years; or otherwise are judged by the investigator as being trained or experienced as a first responder
研究组 & 干预措施
Nasal Glucagon Device (NG)
Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
干预措施: Nasal Glucagon Device (NG) (Device)
Glucagon Emergency Kit (GEK)
Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
干预措施: GEK (Device)
Glucagon Emergency Kit (GEK)
Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
干预措施: IM Glucagon (Drug)
结局指标
主要结局
Percentage of Trained Users That Performed a Successful Administration for Each Device
时间窗: Part A: Days 8 - 9 and Days 15 - 17
Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.
次要结局
- Percentage of Untrained Users That Perform a Successful Administration for Each Device(Part B: Day 1 and Days 8-9)
- Average Time for Trained Users to Successfully Administer One Device Over the Other(Part A: Day 8 and Days 15-17)
- Average Time for Untrained Users to Successfully Administer One Device Over the Other(Part B: Day 1 and Days 8-9)
- Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other(Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9)
- Percentage of Participants (PWD) That Prefer One Device Over the Other(Part A: Days 15 - 17)
- Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other(Part A: Days 15 -17 and Part B: Days 8 - 9)