NCT05268250 · Nemours Children's Clinic
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
(R2D2)
What this study is about
This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes.
View original scientific 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.
Interventions
BEHAVIORAL
R2D2 mHealth intervention
R2D2 mHealth treatment will use cognitive behavioral therapy, mindfulness, and behavioral activation strategies
Primary outcome measures
youth glycated hemoglobin (HbA1c)
Time frame: week 0, week 13
proxy measure of average glycemic levels over 10-12 weeks
youth time in range
Time frame: week 0, week 13
based on continuous glucose levels, the percentage of time spent between 70-180mg/dl
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Jacksonville, Florida
- Kansas City, Missouri
Collaborators
Children's Mercy Hospital Kansas City
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 1, 2026 · Source of record for eligibility and locations