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New program helps kids with type 1 diabetes take control

NCT ID NCT04336969

Disease control Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a program called 4T (Teamwork, Targets, Technology, Tight Control) for children and teens newly diagnosed with type 1 diabetes. The program uses continuous glucose monitor data to give personalized feedback to families. Researchers measured changes in blood sugar levels and how patients felt about using the device. The goal was to improve diabetes management and patient well-being.

What this could mean

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

Active substance
4T Education and Care (behavioral intervention using CGM feedback)
What this could lead to
If successful, this program could help children with new-onset type 1 diabetes better manage their blood sugar and improve their quality of life.
What could go wrong
This is a completed study, so results are already known. The intervention is behavioral, so benefits may vary by family and may not apply to all populations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

316 people

The number who actually took part.

Started

Jun 2020

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

6 months to 21 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: (Inclusion criteria includes all youth with new onset T1D seen in the Stanford/Lucile Packard Children's Hospital ages 6 months-21 years of age. We intend to include all possible patients with the goal of maximizing generalizability of the results and 4T program. (NOTE: We will include children and families who speak all languages using the Stanford interpreter services so as to have the greatest generalizability of the research. Questionnaires will only be given to English and Spanish speakers.) * All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic * Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic * Individuals who agree to CGM data integration into the EMR for remote monitoring * Age: six months to \< 21 years of age * Patient or guardian must own and operate an Apple compatible device (e.g., iPhone or iPod Touch) to allow for the Dexcom app and CGM data transmission to the hospital server-based remote monitoring system. Dr Prahalad's LPCH Auxiliary Fund grant (in addition to the R18) has resources to support iPod Touch/iPhone purchases for participants who do not have these. o For the Exercise Ancillary study: 11 to \< 21 years of age (the activity tracker is not validated for younger children) English and Spanish-Speaking (Study 2) Exclusion Criteria: * Diabetes diagnosis other than T1D * Diagnosis of diabetes \> one month prior to initial visit * Individuals with the intention of obtaining diabetes care at another clinic * Individuals who do not consent to CGM use, CGM data integration, remote monitoring * Individuals \> 21 years of age

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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.

TYPE1DIABETES

Contacts and locations

Locations

  • Franziska Katherine Bishop

    Steamboat Springs, Colorado, 80487, United States

More trials for these conditions

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