PROJECT SUMMARY
While ~25% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of <7.5%, the majority of
school-age children do not and are at a higher risk for T1D-related complications. Achieving optimal T1D self-
care is currently the only direct pathway to better HbA1c and even with the addition of modern therapeutic
modalities (e.g., hybrid closed loop), T1D self-care is a complex, time-consuming, and relentless task. School-
age children need support from their parents to effectively manage T1D and therefore both parents and youth
with T1D are vulnerable to Diabetes Distress (DD). Presently, the American Diabetes Association (ADA)
Standards of Care recommend assessment of DD during routine diabetes clinic visits in youth and their
caregivers starting when youth are ~8-years-old. Unfortunately, while DD screening may be an ADA Care
Standard, there are no practical and evidence-based screen-to-treat programs for clinics to adopt to meet this
Standard of Care. We submit this new R01 in response to RFA-DK-19-021, Treating Diabetes Distress to
Improve Glycemic Outcomes in Type 1 Diabetes. Our objective is to test the feasibility and acceptability of a
novel, practical, and scalable screen-to-treat program for DD in school-age children and their parents (called
Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to reduce DD to improve children's
glycemic control. Our specific aims are: 1) Define and iteratively refine our new screen-to-treat program (R2D2)
for DD in school-age families in order to maximize feasibility and acceptability to stakeholders, and 2) Establish
initial efficacy of R2D2 to reduce parent and child DD to improve child glycemic control. To enhance scientific
rigor, we will use the ORBIT Model for Behavioral Intervention Development to guide our study design. The
ORBIT Model proposes a phased approach using a series of small, cost-effective studies to determine clinically-
meaningful targets and to test a treatment's acceptability and initial efficacy before embarking on a large clinical
trial. For ORBIT Phase 1a: Define, we will conduct a brief longitudinal study to establish cut-points for clinically
relevant DD in parents and school-age children, engage clinic Quality Improvement teams to develop a practical
clinic-based screening approach, and use crowdsourcing techniques to obtain family input on a new mHealth
treatment. For ORBIT Phase 1b: Refine, we will test implementation of our R2D2 screening program across
multiple clinics and we will conduct a small trial to identify an initially efficacious and practical mHealth treatment
delivery approach for R2D2. Finally, for ORBIT Phase 2a, we will continue to screen for DD in clinic and recruit
families who report clinically relevant DD into a Proof of Concept Pilot to examine whether ameliorating parent
and/or child DD leads to improved child glycemic control. We believe our study optimally responds to the FOA
because our: 1-research team is multidisciplinary and includes a true partnership between a behavioral scientist
and a diabetologist, 2-R2D2 screen-to-treat program reflects a practical approach that could realistically occur
in clinic, 3-use of Implementation Science will further enhance future sustainability and dissemination of R2D2.
