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

RECRUITINGN/ASponsored by Nemours Children's Clinic
Actively Recruiting
PhaseN/A
SponsorNemours Children's Clinic
Started2024-02-26
Est. completion2026-08-31
Eligibility
Age8 Years – 65 Years
Healthy vol.Accepted
Locations2 sites

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

Age: 8 Years – 65 YearsHealthy volunteers accepted
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

DiabetesType 1 Diabetes

Locations2 sites

Florida

1 site
Nemours Children's Health
Jacksonville, Florida, 32207
Susana R Patton, PhD9136973595sp0105@nemours.org

Missouri

1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Mark Clements, MD PHD8162343000endoclinicaltrials@cmh.edu

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