NCT05268250

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Feb 2024Aug 2026

First Submitted

Initial submission to the registry

February 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

October 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

February 16, 2022

Last Update Submit

October 28, 2025

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

  • youth glycated hemoglobin (HbA1c)

    proxy measure of average glycemic levels over 10-12 weeks

    week 0, week 13

  • youth time in range

    based on continuous glucose levels, the percentage of time spent between 70-180mg/dl

    week 0, week 13

Secondary Outcomes (4)

  • Problem Areas in Diabetes-Child (PAID-C)

    week 0, week 13

  • Parent Problem Areas in Diabetes-Child (P-PAID-C)

    week 0, week 13

  • Diabetes Strengths and Resilience

    week 0, week 13

  • Brief Resilience Scale

    week 0, week 13

Study Arms (2)

R2D2 mHealth treatment for diabetes distress

EXPERIMENTAL

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

Behavioral: R2D2 mHealth intervention

Standard Care Control

NO INTERVENTION

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 interventionBEHAVIORAL

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

R2D2 mHealth treatment for diabetes distress

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nemours Children's Health

Jacksonville, Florida, 32207, United States

RECRUITING

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Susana R Patton, PhD

    Nemours Children's Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana R Patton, PhD

CONTACT

9046972000susana.patton@nemours.org

Nicole Morales

CONTACT

nicole.morales@nemours.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Scientist

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 7, 2022

Study Start

February 26, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

October 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)