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New insulin pump software tested in kids as young as 2

NCT ID NCT06717451

Disease control Sponsor: Tandem Diabetes Care, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study is checking how safe and effective an updated insulin pump system (Control-IQ 1.5) is for children ages 2 to 6 with type 1 diabetes. About 144 kids will use the pump for a year while researchers track dangerous low blood sugar events and diabetic ketoacidosis. The goal is to see if the technology helps keep blood sugar in a healthy range in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Control-IQ Technology v1.5 (insulin pump software)
What this could lead to
If successful, this could show that the updated pump system is safe and effective for very young children, helping them maintain better blood sugar control.
What could go wrong
This is a small, single-arm observational study with no comparison group, so results may not prove the device is better than other options. Risks include severe hypoglycemia or diabetic ketoacidosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

144 people

The number who actually took part.

Started

Jan 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

2 to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

Contacts and locations

Locations

  • Tandem Diabetes Care

    San Diego, California, 92130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.