4T Sustainability Program

NCT06314048 | Enrolling By Invitation

• 1 other identifier: 74212
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities.

Conditions

Type1diabetes

Keywords

Pediatric; Type 1 Diabetes; Continuous Glucose Monitor; Remote Patient Monitoring; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• HbA1c trajectory observed 4-12 months post-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.

  4-12 months post TID diagnosis

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

  baseline and 12 months post Type 1 Diabetes diagnosis

Study Arms (1)

Standard of Care - CGM and RPM

1\. Implement the 4T program as standard of care at Stanford Diabetes clinics, 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.

Other: CGM and RPM

Interventions

CGM and RPM OTHER

1\. Implement the 4T program as standard of care at Stanford Diabetes clinics, 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.

Standard of Care - CGM and RPM

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients seen at Stanford Children's Diabetes Clinic diagnosed with Type 1 Diabetes.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• David M Maahs, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Endocrinology

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 15, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)