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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT06979635
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes (T1D) for at least 6 months
* 11≤Age≤18 years
* HbA1c \<10.0%
* Current treatment with automated insulin delivery system (AID) or insulin pump for at least 1 month
* Willing to switch to Tandem Mobi Pump System and Dexcom CGM for the study duration
* Competitive-level athletes
Exclusion Criteria:
* Concomitant disease that influences metabolic control or HbA1c interpretation
* Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
* Use of antidiabetic agents other than insulin
* Two or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous 6 months
* One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening
* Individual has a positive pregnancy screening test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
18 Years
Study:
NCT06979635
Study Brief:
Protocol Section:
NCT06979635