Recruiting

Remedy to Diabetes

Sponsor:

Nemours Children's Clinic

Code:

NCT05268250

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 8 - 65

Healthy Volunteers: Not accepted

Interventions

R2D2 mHealth intervention

Study Details

Brief summary:

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

Type 1 Diabetes

Study ID

NCT05268250

Start date

Feb 26, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: R2D2 mHealth treatment for diabetes distress

This is a mHealth supported, cognitive behavioral treatment for parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program

no intervention: Standard Care Control

Parents and school-age children who were identified with clinically relevant levels of diabetes distress as part of a clinic screening program will receive local resources (print or electronic).

Interventions

R2D2 mHealth intervention

R2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies

Primary outcome measure

  • youth glycated hemoglobin (HbA1c) [ Time Frame: week 0, week 13 ]
  • youth time in range [ Time Frame: week 0, week 13 ]

Central Contacts and Locations

Central contacts

Susana R Patton, PhD

9046972000susana.patton@nemours.org

Nicole Morales

nicole.morales@nemours.org

Locations

Nemours Children's Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Susana R Patton, PhD

9136973595sp0105@nemours.org

Amy Milkes

amy.milkes@nemours.org

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Mark Clements, MD PHD

8162343000endoclinicaltrials@cmh.edu

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-09-01.