PS230005 Control-IQ 1.5 Post-Approval Study

NCT06717451 | Active Not Recruiting FDA Device

• 1 other identifier: TP-0017060
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; Control-IQ; Control-IQ 1.5; Tandem; mobi; t:slim X2; automated insulin delivery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percent Time in Range 70 - 180 mg/dL

  12 months

• Percent Time Greater Than 180 mg/dL

  12 months

• Percent Time Greater Than 250 mg/dL

  12 months

• Percent Time Less Than 70 mg/dL

  12 months

• Percent Time Less Than 54 mg/dL

  12 months

Other Outcomes (4)

• Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score

  12 months

• Diabetes Impact and Satisfaction Scale (DIDS), Impact Score

  12 months

• EQ-5D (inclusive of the Visual Analogue Scale (VAS))

  12 months

Study Arms (1)

Control-IQ Technology v1.5

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

Device: Control-IQ Technology v1.5

Interventions

Control-IQ Technology v1.5 DEVICE

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.

Control-IQ Technology v1.5

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• University of California, San Diego: collaborator

Study Sites (1)

Tandem Diabetes Care

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jordan Pinsker, MD

  Chief Medical Officer, Tandem Diabetes Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)