RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-26
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05268250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * child age between 8-12 years, physician confirmed T1D diagnosis,
  2. * either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points,
  3. * child is on an intensive insulin regimen (pump or MDI).
  1. * children on a conventional insulin regimen, children and/or parents who do not report diabetes distress levels at or above the clinical cut-points,
  2. * 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),
  3. * children and parents who do not speak English.

Contacts and Locations

Study Contact

Susana R Patton, PhD
CONTACT
9046972000
susana.patton@nemours.org
Amy Milkes
CONTACT
amy.milkes@nemours.org

Principal Investigator

Susana R Patton, PhD
PRINCIPAL_INVESTIGATOR
Nemours Children's Health

Study Locations (Sites)

Nemours Children's Health
Jacksonville, Florida, 32207
United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Nemours Children's Clinic

  • Susana R Patton, PhD, PRINCIPAL_INVESTIGATOR, Nemours Children's Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes