If you have a child with Type 1 diabetes between the ages of 4 and 16, you may be interested in a study that is currently recruiting volunteers to evaluate a new needle-free glucagon treatment for severe hypoglycemia (low blood glucose).
Glucagon is a hormone that causes the liver to release stored glucose, raising blood glucose levels. Glucagon injections are used to treat people with severe hypoglycemia who cannot swallow food or liquid due to sleepiness, unconsciousness, or seizures. However, mixing and administering the injection can be difficult for bystanders who don’t have medical training, and the injection can also cause significant, if passing, high blood glucose that may result in nausea and vomiting.
To determine whether glucagon administered as a puff into the nose is safe, effective, and well tolerated, researchers are seeking children and adolescents ages 4 to 16 years old who have Type 1 diabetes. Study participants ages 12 to 16 will be required to visit the study site twice and to receive the investigational nasal spray during one visit and an injection of glucagon during the other visit. Participants ages 4 to 11 will be randomly assigned to either have one visit in which they receive a glucagon injection or two visits in which they receive a 2.0-milligram dose of the nasal spray during one visit and a 3.0-milligram dose of the spray during the other visit.
Each visit will involve the child’s glucose level being reduced to about 80 mg/dl either by an increase in the basal rate on his or her insulin pump or by an intravenous infusion of insulin. Five minutes after the glucose levels goes below 80 mg/dl, the child will be treated either with a dose of the spray glucagon or with a dose of the injectable glucagon. Blood glucose levels and adverse events will be closely monitored for 90 minutes after the glucagon is administered.
The study will be conducted at eight centers across the United States. For more, including full information on eligibility criteria and how to enroll, visit clinicaltrials.gov.
This blog entry was written by Web Editor Diane Fennell.
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