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Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests R2D2, a program to find and treat stress from managing type 1 diabetes in families with children ages 8–12. It looks at whether the program is practical, works well for families, and may lower stress and improve children's blood sugar control.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The child is 8–12 years old and has type 1 diabetes confirmed by a doctor.
  • The child, parent, or both report diabetes-related stress that meets the study's cutoff.
  • The child uses an insulin pump or gets several insulin shots each day.

Who can't join

  • The child uses a conventional insulin plan rather than a pump or several daily shots.
  • Neither the child nor the parent reports diabetes-related stress that meets the study's cutoff.
  • The child has an allergy or sensitivity to the glue or skin preparation used for a continuous glucose monitor, a device that tracks blood sugar.
  • The child has another long-term health condition, such as kidney disease.
  • The child and parent do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

FL

MO