PS230005 Control-IQ 1.5 Post-Approval Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Control-IQ Technology v1.5

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 Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • Tandem Diabetes Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Enrollment in the study will be available to all individuals age 2 to <6 years of age at time of screening who start therapy with Control-IQ Technology v1.5.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Control-IQ Technology v1.5; Real-world use of Control-IQ technology v1.5 for 12 months.

Device: Control-IQ Technology v1.5; Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5. Every month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score	DIDS satisfaction score at baseline, and after 6 and 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.	12 months
Diabetes Impact and Satisfaction Scale (DIDS), Impact Score	DIDS impact score at baseline, and after 6 and 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.	12 months
EQ-5D (inclusive of the Visual Analogue Scale (VAS))	Questionnaire score at baseline, and after 6 and 12 months of Control-IQ use.	12 months
Hypoglycemia Fear Survey - Parent for Young Children Version (HFS-P-YC)	Questionnaire score at baseline, and after 6 and 12 months of Control-IQ use.	12 months

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Jordan Pinsker, MD, Chief Medical Officer, Tandem Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: type 1 diabetes; automated insulin delivery; Tandem; Control-IQ; t:slim X2; Control-IQ 1.5; mobi
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: TP-0017060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No