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

Running, not enrolling · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT05268250

Run by

Nemours Children's Clinic

People needed

180

Starts

2024-02-26

Expected to finish

2026-08-31

Last updated by the study team

2026-06-29

Who can join

Age: 8 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.