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RECRUITING Not applicable ClinicalTrials.gov

Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families

Sponsor: Nemours Children's Clinic • ClinicalTrials.gov ID: NCT05268250

Registry updated: 2026-09-01
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Description

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.

Interventions

  • R2D2 mHealth intervention (Behavioral)
    R2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies

Eligibility criteria

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.

Conditions

Type 1 Diabetes

Locations

  • Nemours Children's Health — Jacksonville, Florida, United States
  • Children's Mercy Kansas City — Kansas City, Missouri, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record