PS230005 Control-IQ 1.5 Post-Approval Study

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06717451
• Lead Sponsor: Tandem Diabetes Care, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-05
• Status Verified: 2025-01
• Study Start: 2025-01-30
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence Rates of Severe Hypoglycemia (SH)	12 months	Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use
Incidence Rates of Diabetic Ketoacidosis (DKA)	12 months	Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use

Secondary Outcome Measures

Name	Time	Method
Percent Time Greater Than 250 mg/dL	12 months	CGM measured percent time \>250 mg/dL during 12 months of Control-IQ use
Percent Time Less Than 70 mg/dL	12 months	CGM measured percent time \<70 mg/dL during 12 months of Control-IQ use
Percent Time in Range 70 - 180 mg/dL	12 months	CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use
Percent Time Greater Than 180 mg/dL	12 months	CGM measured percent time \>180 mg/dL during 12 months of Control-IQ use
Percent Time Less Than 54 mg/dL	12 months	CGM measured percent time \<54 mg/dL during 12 months of Control-IQ use
Mean Glucose mg/dL	12 months	CGM measured mean glucose during 12 months of Control-IQ use

Trial Locations

Locations (1)

Tandem Diabetes Care; 🇺🇸 San Diego, California, United States