PS230005 Control-IQ 1.5 Post-Approval Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to \<6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 5
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
Tandem Diabetes Care
RECRUITING
San Diego
Contact Information
Primary
Kirstin Whilte, CCRA
cliostudy@tandemdiabetes.com
858-336-6900
Time Frame
Start Date: 2024-12-13
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 120
Treatments
Control-IQ Technology v1.5
Real-world use of Control-IQ technology v1.5 for 12 months.
Sponsors
Collaborators: University of California, San Diego
Leads: Tandem Diabetes Care, Inc.

This content was sourced from clinicaltrials.gov