Summary

Eligibility
for people ages 2-5 (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Details

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.

Keywords

Type 1 Diabetes, Control-IQ, Control-IQ 1.5, Tandem, mobi, t:slim X2, automated insulin delivery, Type 1 Diabetes Mellitus

Eligibility

You can join if…

Open to people ages 2-5

  • 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).

You CAN'T join if...

  • 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.

Location

  • Tandem Diabetes Care
    San Diego California 92130 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Tandem Diabetes Care, Inc.
ID
NCT06717451
Study Type
Observational
Participants
Expecting 120 study participants
Last Updated