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

Location

  • Tandem Diabetes Care accepting new patients
    San Diego California 92130 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tandem Diabetes Care, Inc.
ID
NCT06717451
Study Type
Observational
Participants
Expecting 120 study participants
Last Updated