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Nasal Glucagon for Type 1 Diabetes (RescuiNGkids Trial)
RescuiNGkids Trial Summary
This trial is testing the safety and tolerability of a new diabetes drug for children aged 1-4. It will involve blood tests and measuring blood sugar levels. The study will last up to 9 days.
RescuiNGkids Trial Timeline
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RescuiNGkids Trial Design
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- You are using a specific type of insulin therapy device, unless it is set to a different mode on the day of the treatment visit.Your HbA1c level (a measure of blood sugar control) is lower than 9.5%.You were born with nose abnormalities or need surgery to change the shape of your nose.You have a history of epilepsy or seizures.You have been diagnosed with Type 1 Diabetes for at least 6 months.You are allergic to glucagon.You have had a type of tumor called pheochromocytoma in the past.You need to be in good health except for having Type 1 diabetes, and you cannot have a history of certain nose or throat problems.You have been using insulin injections or a pump regularly for at least 3 months before the screening.You had a very low blood sugar episode or needed glucagon in the last 3 months before your screening, and you didn't have another very low blood sugar episode between the screening and dosing visits.You have veins that can be used to draw blood for testing.
- Group 1: Glucagon Nasal Powder
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What prior investigations have been conducted involving Glucagon Nasal Powder [Baqsimi]?
"Initially investigated in 2018 at the University of Texas Health Science Center, Baqsimi has since seen a total of 76 clinical trials. Currently there are 8 ongoing studies located predominantly within Los Angeles."
May I be eligible to join this research endeavor?
"This clinical trial seeks 9 children between one and four years old with type 1 diabetes mellitus. Eligible candidates must have sufficient venous access for blood sampling, demonstrate stability on insulin therapy for at least three months before screening, possess generally good health besides their Type 1 Diabetes Mellitus diagnosis, and not be burdened by prior choanal atresia or any other form of nasal/pharyngeal blockage or anomaly."
What is the capacity of this clinical trial in terms of participants?
"Affirmative. Per information accessible on clinicaltrials.gov, the medical trial in question is actively looking for participants and has been active since March 24th 2022. The study seeks to recruit 9 volunteers from 10 different sites across the country."
Is recruitment for this research endeavor open to the public?
"Affirmative. Per information hosted on clinicaltrials.gov, this medical study is in the midst of recruiting patients which began upon its initial posting on March 24th 2022 and was last modified October 3rd 2022. The researchers are looking for 9 participants to take part at 10 different sites."
For which ailments is Baqsimi, a Glucagon Nasal Powder typically prescribed?
"Glucagon Nasal Powder [Baqsimi] is a viable option for managing type 2 diabetes mellitus, diabetes, and hypoglycemia."
Is this research project open to participants over the age of 80?
"This study is looking to enrol individuals between the ages of one and four years old. It has been reported that 220 medical trials are catering to those under 18 while 924 studies aim to accommodate persons over 65."
In which locations is this assessment being conducted?
"This study has locations in Los Angeles, Indianapolis and Minneapolis, as well as 10 other sites. Specifically, Children's Hospital Los Angeles (Los Angeles), Riley Hospital for Children (Indianapolis) and University of Minnesota Medical School (Minneapolis)."
What risks do people face when ingesting Glucagon Nasal Powder [Baqsimi]?
"With a score of 1, Glucagon Nasal Powder [Baqsimi] is classified as having limited safety and efficacy data. This evaluation was based on the fact that this medication is in its initial clinical trial phase."
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