Monitoring the safety of Control-IQ technology in young children with type 1 diabetes
PS230005 Control-IQ 1.5 Post-Approval Study
This study is testing the safety of Control-IQ technology in young children with type 1 diabetes to see how it affects their blood sugar levels and overall health over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | Tandem Diabetes Care, Inc. Industry-sponsored |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06717451 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to less than 6 years who have been prescribed the Control-IQ 1.5 system and have self-reported type 1 diabetes.
Not a fit: Patients who do not have type 1 diabetes or are older than 6 years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Control-IQ technology for managing type 1 diabetes in young children.
How similar studies have performed: While this study is focused on a specific age group and technology, similar studies on diabetes management technologies have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.