Status:
RECRUITING
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Children's Mercy Hospital Kansas City
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
8-65 years
Phase:
NA
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, ...
Detailed Description
Only 22% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of \<7.5% while the majority of school-age children who exceed this target are at higher risk for T1D-related complications....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05268250
Start Date
February 26 2024
End Date
August 31 2026
Last Update
October 30 2025
Active Locations (2)
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1
Nemours Children's Health
Jacksonville, Florida, United States, 32207
2
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108