NCT05268250 Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
| NCT ID | NCT05268250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nemours Children's Clinic |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-02-26 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Susana R Patton, PhD
PRINCIPAL INVESTIGATOR
Nemours Children's Health
Frequently Asked Questions
Who can join the NCT05268250 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 65 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05268250 currently recruiting?
Yes, NCT05268250 is actively recruiting participants. Contact the research team at susana.patton@nemours.org for enrollment information.
Where is the NCT05268250 trial being conducted?
This trial is being conducted at Jacksonville, United States, Kansas City, United States.
Who is sponsoring the NCT05268250 clinical trial?
NCT05268250 is sponsored by Nemours Children's Clinic. The principal investigator is Susana R Patton, PhD at Nemours Children's Health. The trial plans to enroll 180 participants.
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