PS230005 Control-IQ 1.5 Post-Approval Study

Tandem Diabetes Care

Status

Active, not recruiting

Conditions

Type 1 Diabetes

Treatments

Device: Control-IQ Technology v1.5

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06717451

TP-0017060

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion 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).

Exclusion criteria

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.