NCT05268250Recruiting
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 16 Feb 2022
- Start date
- 26 Feb 2024
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Nemours Children's Clinic
- Diseases
- Type 1 diabetes
- NCT number
- NCT05268250
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 26 Feb 2024 to the primary completion date, 31 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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),
Other
- children and parents who do not speak English.
Who the study is looking for
- 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).
Age in the registry: 8 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemours Children's Health Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Children's Mercy Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.