4T Sustainability Program

Enrolling by invitation

Conditions studied: Type1diabetes

In brief

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.

Key facts

Study ID

NCT06314048

Run by

Stanford University

People needed

5000

Starts

2024-05-30

Expected to finish

2028-01-31

Last updated by the study team

2025-05-21

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. The program will also be offered to pediatric patients with existing T1D who wear a CGM or want to start a CGM and receive RPM. 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 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

Where it is running

• Lucile Packard Children's Hospital — Palo Alto, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.