Program to help families manage diabetes distress in children
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
This study is testing a new program to help families of school-age children with Type 1 Diabetes manage stress related to the condition and see if it improves their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 8 Years to 65 Years |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT05268250 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate a new program called Remedy to Diabetes Distress (R2D2) designed to help families of school-age children with Type 1 Diabetes (T1D) manage diabetes distress. The program will assess the feasibility and acceptability of a mobile health intervention that targets both children and their parents, focusing on reducing diabetes distress to improve glycemic control. By addressing the emotional and psychological challenges associated with T1D, the study seeks to enhance the overall management of the condition in young patients. The initial efficacy of the R2D2 program will also be tested to determine its impact on children's health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8-12 years with a physician-confirmed diagnosis of Type 1 Diabetes who experience diabetes distress.
Not a fit: Patients who are on a conventional insulin regimen or do not report diabetes distress levels at or above clinical cut-points may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the emotional well-being of families and enhance glycemic control in children with Type 1 Diabetes.
How similar studies have performed: While there is ongoing research into diabetes distress, this specific approach with a scalable program for families is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida and 1 other locations
- Nemours Children's Health — Jacksonville, Florida, United States (Recruiting)
- Children's Mercy Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Susana R Patton, PhD — Nemours Children's Health
- Study coordinator: Susana R Patton, PhD
- Email: susana.patton@nemours.org
- Phone: 9046972000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.