Monitoring the safety of Control-IQ technology in young children with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect safety data on Control-IQ technology version 1.5 in children aged 2 to less than 6 years with type 1 diabetes. Participants will use the Control-IQ system for 12 months in a real-world setting, with a target of at least 120 participants completing the study. The primary focus is on monitoring the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH), while secondary outcomes include continuous glucose monitoring (CGM) time in range and patient-reported outcomes. The study is decentralized, allowing for a broad recruitment of participants across the United States.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tandem Diabetes Care
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Jordan Pinsker, MD — Chief Medical Officer, Tandem Diabetes Care
• Study coordinator: Kirstin Whilte, CCRA
• Email: cliostudy@tandemdiabetes.com
• Phone: 858-336-6900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.