PS230005 Control-IQ 1.5 Post-Approval Study

Description

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.

Conditions

Type 1 Diabetes

Study Overview

Study Details

Study overview

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.

PS230005 Control-IQ 1.5 Post-Approval Study

PS230005 Control-IQ 1.5 Post-Approval Study

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

San Diego

Tandem Diabetes Care, San Diego, California, United States, 92130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

2 Years to 5 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tandem Diabetes Care, Inc.,

Jordan Pinsker, MD, PRINCIPAL_INVESTIGATOR, Chief Medical Officer, Tandem Diabetes Care

Study Record Dates

2026-12-15