Program to help families manage diabetes distress in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.