Actively Recruiting

Phase Not Applicable
Age: 8Years - 65Years
All Genders
NCT05268250

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

Led by Nemours Children's Clinic · Updated on 2025-10-30

180

Participants Needed

2

Research Sites

131 weeks

Total Duration

On this page

Sponsors

N

Nemours Children's Clinic

Lead Sponsor

C

Children's Mercy Hospital Kansas City

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child age between 8 and 12 years
  • Physician-confirmed diagnosis of type 1 diabetes
  • Child or parent or both report diabetes distress at or above clinical cut-points
  • Child is on an intensive insulin regimen (pump or multiple daily injections)
Not Eligible

You will not qualify if you...

  • Child on a conventional insulin regimen
  • Child or parent do not report diabetes distress at or above clinical cut-points
  • Child has allergy or sensitivity to adhesive or skin preparation used for continuous glucose monitoring (CGM)
  • Child has a comorbid chronic condition (e.g., renal disease)
  • Child or parent do not speak English

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nemours Children's Health

Jacksonville, Florida, United States, 32207

Actively Recruiting

2

Children's Mercy Kansas City

Kansas City, Missouri, United States, 64108

Actively Recruiting

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Research Team

S

Susana R Patton, PhD

CONTACT

N

Nicole Morales

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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