Back to search results

R2D2: A Program for Diabetes Distress in Families of Children with Type 1 Diabetes

This study, called Remedy to Diabetes Distress (R2D2), is testing a new program designed to help families of school-aged children with Type 1 Diabetes (T1D) manage diabetes distress. Diabetes distress is the emotional burden and stress that comes with managing diabetes. The R2D2 program uses strategies like cognitive behavioral therapy, mindfulness, and behavioral activation. We want to see if this program can reduce diabetes distress and improve children's blood sugar control, specifically their HbA1c (a measure of average blood sugar over 2-3 months) and time in range (how long blood sugar stays within a healthy target). We are looking for children aged 8-12 with T1D who are on an intensive insulin regimen (pump or multiple daily injections), and either the child or parent reports high levels of diabetes distress. The study plans to enroll 180 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 180 participants, including children aged 8-12 and their parents.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at week 0 and week 13, suggesting a follow-up period of at least 13 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05268250

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

Recruiting
NAAges 8–65InterventionalTreatment
Nemours Children's Clinic
~180 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:R2D2 mHealth intervention

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
youth glycated hemoglobin (HbA1c)
Measured over week 0, week 13
+1 more outcome measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

2 sites across 2 states
Florida1
Missouri1

Study leadership

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

Who to contact

Susana R Patton, PhD
[email protected]
9046972000
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • youth glycated hemoglobin (HbA1c)week 0, week 13

    proxy measure of average glycemic levels over 10-12 weeks

  • youth time in rangeweek 0, week 13

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