This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in families of school-age children with T1D (called Remedy to Diabetes Distress \[R2D2\]) and to test the initial efficacy of R2D2 to reduce diabetes distress to improve children's glycemic control.
child age between 8-12 years, physician confirmed T1D diagnosis,
either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points,
child is on an intensive insulin regimen (pump or MDI).
children on a conventional insulin regimen, children and/or parents who do not report diabetes distress levels at or above the clinical cut-points,
children who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM, children with a comorbid chronic condition (e.g., renal disease),
children and parents who do not speak English.
Parallel
R2D2 mHealth intervention
BehavioralR2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies
youth glycated hemoglobin (HbA1c)
proxy measure of average glycemic levels over 10-12 weeks
youth time in range
based on continuous glucose levels, the percentage of time spent between 70-180mg/dl
Problem Areas in Diabetes-Child (PAID-C)
validated child report of diabetes distress; range: 11-66, higher scores reflect greater distress
Parent Problem Areas in Diabetes-Child (P-PAID-C)
validated parent report of diabetes distress; range 16-96, higher scores reflect greater distress
Diabetes Strengths and Resilience
validated child report of resilience; range: 12-60, higher scores reflect greater resilience
Brief Resilience Scale
validated adult report of resilience; range 1-5, higher scores reflect greater resilience
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Nemours Children's Clinic
Lead sponsor
Children's Mercy Hospital Kansas City
Collaborator
