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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06717451
Eligibility Criteria:
Inclusion Criteria:
* Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
* Age 2 to \<6 years at time of screening
* Using an insulin approved for use in the pump
* Using an iCGM sensor approved for use with the pump
* Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
* Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
* Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
* Reside full-time in the United States.
* Willingness to download the t:connect Mobile application to their smartphone and keep it active throughout the study if using a Tandem t:slim X2 pump. Participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to Tandem Source every three months and at the completion of the study.
* Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
Exclusion Criteria:
* Use of any glucose-lowering therapy other than insulin.
* A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
5 Years
Study:
NCT06717451
Study Brief:
Protocol Section:
NCT06717451