4T Sustainability Program

NCT ID: NCT06314048

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2028-01-31

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.

Detailed Description

The investigators propose a multi-disciplinary diabetes team approach to utilize existing and emerging diabetes technologies and education strategies to implement scalable diabetes care with the goal of maintaining tight control for newly diagnosed Pediatric T1D patients. Successful T1D care is more than glucose control; the 4T program will closely monitor psychosocial and patient-reported outcomes (PROs) through the established psychosocial screening and treatment program. The 4T program will utilize automated approaches to analyze glucose profiles developed in conjunction with the Stanford SURF (Systems Utilization Research For Stanford Medicine) team. The 4T program will tailor intervention to those patients most in need of team support employing a broad range of behavioral and technology supports, strengths of the Stanford Pediatric Diabetes program. The 4T program approach more precisely adapts care to patient needs and optimizes glucose and psychosocial outcomes.

Therefore, the investigators propose to expand the diabetes team approach (Teamwork, Targets, and Technology for Tight Control: 4T), which utilizes existing diabetes technologies and education strategies to implement and standardize goal-oriented diabetes care for newly diagnosed pediatric T1D patients, to a standard of care program at Stanford pediatric diabetes clinics. The Stanford diabetes team has revised the diabetes education approach to set clear and tighter targets at new-onset through the early phase of T1D and to be aggressive with the intensification of control as insulin needs and care demands increase. The 4T Sustainability program will further standardize T1D team care while allowing for personalization based on patient/family needs with the goal of optimizing glucose and psychosocial outcomes. (NOTE: the current protocol [IRB #52812] focuses on early initiation of CGM as the key technology for glucose monitoring. The 4T program is designed to be flexible to incorporate emerging technologies as they become available for patient care. For example, automated insulin delivery systems will be supported as part of the program). To make the 4T Sustainability Program a true standard of care program, remote patient monitoring (RPM) of the CGM data and CDCES-tailored patient contacts will be billed using RPM billing codes. These RPM billing codes have received hospital compliance approval, and billing workflows will be available in LPCH EPIC.

Personalized Goals and Automated Identification for Need for Insulin Changes in New Onsets: Data collected by continuous glucose monitoring (CGM) can improve the quality of patient care; facilitate the use of telemedicine to reduce costs and improve convenience; and improve the understanding of how daily behaviors shape long-term outcomes.

Modern Electronic Health Records (EHRs) can potentially be used to reduce the workload necessary to care for patients; reduce error rates by automating alerts; and facilitate continuous evaluation and improvement of provider adherence to best-practices. To be practical and scalable, these systems must provide actionable information and require relatively few inputs. The investigators have developed stand-alone tools that analyze CGM time series data to set personalized care goals and to determine when glucose values increase, or insulin dose adjustments and other care adaptations are required. To allow Stanford and the broader community to realize the full potential of such tools, the investigators will implement and refine their use in our clinics:

1. Implement and refine analytical methods and software tools to interpret and improve the quality of time-series CGM data, set personalized goals, and generate automated notifications for care providers.

2. A data-driven intervention to improve long-term outcomes for early onset patients including a hospital- server-based monitoring system to evaluate the intervention. [Note: identification is the goal of the system and medical advice will be solely given by trained healthcare professionals.]

Conditions

Type1diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

CGM and RPM

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David Maahs

Chief of Pediatric Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Maahs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

Other Identifiers

74212

Identifier Type: -

Identifier Source: org_study_id