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NCT06314048

4T Sustainability Program

Enrolling by Invitation
Not specifiedAges 6–21Observational
Stanford University
~5,000 participants
Updated 2025-05-21 on ClinicalTrials.gov
What's tested:CGM and RPM

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HbA1c trajectory observed 4-12 months post-diagnosis
Measured over 4-12 months post TID diagnosis
+1 more outcome measured

Conditions

Type1diabetes

Where it's being run

1 sites across 1 states
California1

Study leadership

  • David M Maahs, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

All individuals with a 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 wear a CGM that will connect to the RPM-care model
Age: six months to \< 21 years of age
Patient or guardian must own and operate a compatible smart device/phone to send data from the CGM into the HIPAA-compliant RPM-care model for data analysis and review by a care team member.
Dr. Maahs and Pediatric Endocrinology have philanthropic funds available to purchase compatible smart devices for participants who do not have a compatible smart device/phone.

Exclusion

Diabetes diagnosis other than T1D
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

What this trial measures

  • HbA1c trajectory observed 4-12 months post-diagnosis4-12 months post TID diagnosis

    Implement 4T program as standard of care, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.To address Aim 1, the investigators will use generalized linear mixed effects regression techniques that allows for two piecewise linear slopes of HbA1c levels to be estimated from diagnosis to 4 months and from 4 to 12 months post-diagnosis to determine the effect of the 4T diabetes intervention on changes in HbA1c between 4- and 12-months post-diagnosis and compare observed increases to those in our internal and external contemporaneous controls via separate models. Each mixed effects model will include a subject-specific random effect to account for the correlation of HbA1c within a person over time, and these models will be adjusted for sex, age, ethnicity, and insurance type at diagnosis.

  • Diabetes distress measured at baseline and 12 months post-diagnosis.baseline and 12 months post Type 1 Diabetes diagnosis

    The investigators will utilize generalized linear mixed effects models to address Aim 2. More specifically, the investigators will regress diabetes distress index on use of CGM. Such a model will include a subject-specific random effect and an indicator of whether the patient utilized CGM technologies. Assuming the ratio of using CGM technology is 0.6 and SD of diabetes distress score is 3, we have 90% power to detect a two-unit reduction on mean diabetes distress score.