ACTIVE_NOT_RECRUITING

PS230005 Control-IQ 1.5 Post-Approval Study

Talk to us

Conditions

Type 1 DiabetesControl-IQControl-IQ 1.5Tandemmobit:slim X2automated insulin delivery

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

PS230005 Control-IQ 1.5 Post-Approval Study

Quick Facts

Study Start:2025-01-30
Study Completion:2026-08-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06717451

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.

Ages Eligible for Study:2 Years to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
  2. * Age 2 to \<6 years at time of screening
  3. * Using an insulin approved for use in the pump
  4. * Using an iCGM sensor approved for use with the pump
  5. * Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
  6. * Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
  7. * Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
  8. * Reside full-time in the United States.
  9. * 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.
  10. * Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
  1. * Use of any glucose-lowering therapy other than insulin.
  2. * 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.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Tandem Diabetes Care
San Diego, California, 92130
United States

Collaborators and Investigators

Sponsor: Tandem Diabetes Care, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30
Study Completion Date2026-08-11

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2026-08-11

Terms related to this study

Keywords Provided by Researchers

  • type 1 diabetes
  • Control-IQ
  • Control-IQ 1.5
  • Tandem
  • mobi
  • t:slim X2
  • automated insulin delivery

Additional Relevant MeSH Terms

  • Type 1 Diabetes