The goal of the 4T study is to implement proven methods and emerging diabetes technology into our clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient reported and psychosocial outcomes. We will define a program (4T---Teamwork, Targets, Technology and Tight Control) translatable to Pediatric Diabetes clinics in the United States that reduces HbA1c and T1D burden and improves patient well-being. In response to the R18 mechanism, we have designed a pragmatic approach to study a re-designed diabetes education and care delivery program in newly diagnosed Pediatric T1D patients. The primary outcome will be to implement 4T education and care in newly diagnosed T1D patients to reduce the rise in HbA1c observed 6 months post-diagnosis. We will compare results to historic data from our clinic and to contemporaneous new onset HbA1c data in the USA and internationally. Our secondary aims are to refine a systematic, pragmatic approach to monitoring longitudinal Patient Reported Outcomes and Psychosocial Outcomes and to develop and test in a randomized trial an automated system to detect the need for insulin dose adjustment in between quarterly visits. We will do so by using glucose data to generate personalized management recommendations based on each patient?s physiological and psychosocial data. The research outlined in this proposal aims to lower HbA1c, develop glucose data management and communication systems and support the psychosocial challenges of T1D in a program that is practical, sustainable, and translatable to other Pediatric Diabetes clinics in the US. Specific innovations will be to develop: 1) best practices for providers & T1D patients for glucose and psychosocial outcomes; 2) systems to identify patients with changing insulin needs based on glucose data obtained in between visits; 3) integration of these glucose data into EMR to incorporate into routine clinical practice. In sum, we propose leveraging existing staff and resources to test an innovative approach to improve T1D treatment in our clinic with the goal of obtaining results that will improve healthcare practice and inform healthcare policy for T1D management. We will assess factors that inform sustainability, acceptability, and feasibility. By design, the approach being tested is practical and sustainable with the potential to be broadly disseminated across the US and to improve processes of care and health outcomes for the Pediatric T1D population.

Public Health Relevance

To improve care in newly diagnosed Pediatric type 1 diabetes patients we propose using a combination of (4T) Teamwork, Targets, and Technology to maintain Tight glucose control to optimize patient glucose and psychosocial outcomes. We will use an integrated approach to care and develop automated glucose data management and psychosocial monitoring systems that can be translated to other US clinics to optimize glucose control and reduce burden on patients, families, and health care teams. The research outlined in this proposal aims to lower HbA1c, develop glucose data management and communication systems and support the psychosocial challenges of T1D in a program that is practical, sustainable, and translatable to other Pediatric Diabetes clinics in the US.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Demonstration and Dissemination Projects (R18)
Project #
5R18DK122422-02
Application #
10102243
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Linder, Barbara
Project Start
2020-02-07
Project End
2025-01-31
Budget Start
2021-02-01
Budget End
2022-01-31
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Stanford University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305