PS230005 Control-IQ 1.5 Post-Approval Study

Last updated: November 8, 2025
Sponsor: Tandem Diabetes Care, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Treatment

Control-IQ Technology v1.5

Clinical Study ID

NCT06717451
TP-0017060
  • Ages 2-5
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system inthe 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 12consecutive months after study enrollment.

  • Agree to provide HbA1c result, obtained within the 6-month period prior toenrollment.

  • Ability for parent/guardian to respond to alerts and alarms, and to provide basicdiabetes self-management.

  • Reside full-time in the United States.

  • Willingness to download the t:connect Mobile application to their smartphone andkeep it active throughout the study if using a Tandem t:slim X2 pump. Participantswho are unable to use the t:connect mobile application must be willing to manuallyupload their insulin pump data to Tandem Source every three months and at thecompletion of the study.

  • Participant's parent/guardian has read, understood and agreed to participate in thestudy, and has electronically signed the Informed Consent Form (ICF).

Exclusion

Exclusion Criteria:

  • Use of any glucose-lowering therapy other than insulin.

  • A medical or other condition, or medications being taken that in the investigator'sjudgement would be a safety concern for participation in the study.

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: Control-IQ Technology v1.5
Phase:
Study Start date:
January 30, 2025
Estimated Completion Date:
August 11, 2026

Study Description

The study will recruit participants age 2 to <6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.

Connect with a study center

  • Tandem Diabetes Care

    San Diego, California 92130
    United States

    Site Not Available

  • Tandem Diabetes Care

    San Diego 5391811, California 5332921 92130
    United States

    Site Not Available

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