A New Option for Emergency Hypoglycemia in Children?
By Emma Ryan and Peter Rentzepis
A study in California is enrolling to test dasiglucagon, an emergency treatment for severe hypoglycemia delivered via autoinjector, in children ages 6-17
Clinical Trials Identifier: NCT03667053
Trial name: Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
Diabetes type: Type 1
What the trial is testing: This study is evaluating the effectiveness and safety of dasiglucagon, a rescue treatment for emergency severe hypoglycemia (low blood sugar requiring third-party assistance), in children ages 6-17. A previous study in adults has already shown that 99% participants recovered from hypoglycemia within 15 minutes of treatment with dasiglucagon.
What the trial is measuring: After inducing a controlled episode of hypoglycemia under close supervision, researchers will record the time to glucose recovery (defined as an increase of at least 20 mg/dl).
Why is this new/important? Currently available glucagon kits require mixing a powder and liquid prior to injection, which is time-consuming and difficult to do in an emergency situation. To make emergency hypoglycemia situations safer and easier to treat, companies are developing “ready to use” glucagon treatment options such as dasiglucagon, which will work like an EpiPen autoinjector. Xeris’ glucagon rescue pen and Lilly’s nasal glucagon spray also promise to be far easier to use, and both are currently under FDA review. Dasiglucagon has shown positive trial results in adults and will likely be submitted to the FDA in 2019 for approval in adults. If the results from this study are positive, Zealand will then be able to pursue approval in children.
Trial location: Escondido, California
Do you qualify? Select eligibility criteria include:
Between 6 and 18 years of age
Type 1 diabetes for at least one year
Body weight at least 44 pounds
No history of anaphylaxis or symptoms of severe systemic allergy
No episodes of severe hypoglycemia requiring third party assistance within the last month
No history of epilepsy or seizure disorder
See here for a full list
Where to get more information: Contact Dorte Skydsgaard at email@example.com.