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:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT01693302
Eligibility Criteria:
Inclusion Criteria:
* 12 to 30 years of age, inclusive
* Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year
* Using carbohydrate counting to dose meal time insulin
* HbA1c value upon enrollment greater than 6.0% and less than 12.0%
* Using CSII therapy for diabetes management for at least three months
* Able and willing to give informed consent/assent to participate
* No expectation that the subject will be moving out of the area of the clinical center during the study
* Willing to consume the same standard frozen meal on all three visits
Exclusion Criteria:
* The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the CGMS sensors or the completion of any aspect of the protocol
* Being unable or unwilling to give informed consent
* Having documented hypoglycemia unawareness
* An episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
30 Years
Study:
NCT01693302
Study Brief:
Protocol Section:
NCT01693302