Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT05540132
Eligibility Criteria:
Inclusion Criteria:
* Age 12 - \<18 year old male and female subjects with Type 1 diabetes for \> 1 year
* HbA1c \<10.5%
* Body Mass Index \>10th % and \<95th%
* Not being treated with sensor-augmented pump therapy
* Ability to participate in exercise activity - biking
* Willing to wear a continuous glucose monitor (CGM) sensor
Exclusion Criteria:
* Severe hypoglycemia (requiring glucagon or external assistance) in last 6 months
* Admission for diabetic ketoacidosis in last 3 months
* History of chronic lung disease, congenital heart disease or chronic asthma
* Food (including corn)/dye allergies
* Other chronic medical conditions except for well-controlled thyroid disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05540132
Study Brief:
Protocol Section:
NCT05540132