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4T Sustainability Program

Launched by STANFORD UNIVERSITY · Mar 10, 2024

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

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

ClinConnect Summary

The 4T Sustainability Program is a clinical trial designed to help children and young adults with type 1 diabetes (T1D) manage their blood sugar levels more effectively. The program focuses on using teamwork, setting specific health goals, utilizing advanced diabetes technology, and maintaining tight control over glucose levels. By doing this, the study aims to improve not only patients' blood sugar control but also their overall quality of life and emotional well-being. The goal is to make these proven methods a standard part of diabetes care at Stanford Pediatric Diabetes Endocrinology.

To participate, you need to be between the ages of 6 months and 21 years and have been diagnosed with type 1 diabetes. If you are already using a continuous glucose monitor (CGM) or want to start one, you can join the program. Participants will need a compatible smartphone to share their CGM data with the care team, but assistance is available if you don't have a device. Throughout the program, you can expect support from healthcare professionals who will help you manage your diabetes using the latest technology. This trial welcomes all families, including those who speak different languages, to ensure everyone can benefit from this innovative approach to diabetes care.

Gender

ALL

Eligibility criteria

  • 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. 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.
  • Exclusion Criteria:
  • 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

About Stanford University

Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.

Locations

Palo Alto, California, United States

Patients applied

0 patients applied

Trial Officials

David M Maahs, MD, PhD

Principal Investigator

Stanford University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported