Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
NCT05268250
Summary
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.
Eligibility
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Conditions2
Locations2 sites
Florida
1 siteMissouri
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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NCT05268250