NCT04336969

Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

The 4T program encompasses: Teamwork, Targets, Technology, and Tight Range. These methods will help patients better manage their condition of Type 1 Diabetes with improved patient-reported outcomes.

Detailed description

The goal of the 4T study is to implement proven methods and emerging diabetes technology into the investigator's clinical practice to sustain a tight glucose range from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will define a program (4T - Teamwork, Targets, Technology, and Tight Range) translatable to Pediatric Diabetes clinics in the United States that reduces HbA1c and T1D burden and improves patient well-being. Study Design: This is a prospective, open-label, pragmatic research study. Two related studies will be performed. In Study 1, a cohort of new-onset T1D participants (diagnosed 2020-2022) will receive the 4T new onset intervention, designed to decrease the rise in HbA1c seen from 4 to 12 months, with a weekly remote monitoring schedule, and will be compared to internal (4T Pilot - participants diagnosed with T1D between 2018-2020) and historical controls (patients diagnosed with T1D between 2014-2016). In Study 2, a cohort of new-onsets T1D participants (diagnosed 2022-2024) receiving the 4T new onset intervention designed to decrease the rise in HbA1c seen from 4 to 12 months but following a tapered (from weekly to monthly) remote monitoring schedule will be compared to internal (4T Pilot - participants diagnosed with T1D between 2018-2020 and 4T Study 1 - participants diagnosed with T1D between 2020-2022) and historical controls (patients diagnosed with T1D between 2014-2016).

Conditions

• Type1diabetes

Interventions

Type	Name	Description
BEHAVIORAL	4T Education and Care	CGM data will be used to create customized weekly or monthly feedback to the participant/family by secure MyChart message.

Timeline

• Start date: 2020-06-18
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2020-04-07
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States