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R2D2 mHealth treatment for diabetes distress for Type 1 Diabetes (R2D2 Trial)

N/A
Recruiting
Led By Susana R Patton, PhD
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child age between 8-12 years with physician confirmed T1D diagnosis
Child is on an intensive insulin regimen (pump or MDI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 13
Awards & highlights

R2D2 Trial Summary

This trial aims to test a new program called Remedy to Diabetes Distress (R2D2) for families of school-age children with Type 1 Diabetes. The goal is to see if this

Who is the study for?
This trial is for families with children aged 8-12 who have Type 1 Diabetes (T1D). The child or parent must be experiencing diabetes-related stress, and the child should be on an intensive insulin regimen. It's not specified who can't join, but typically those not meeting these criteria would be excluded.Check my eligibility
What is being tested?
The R2D2 mHealth intervention is being tested to see if it can reduce stress related to managing T1D in school-age children and their families, which may help improve the children's blood sugar control.See study design
What are the potential side effects?
Since this study involves a mobile health intervention rather than medication, traditional side effects are not expected. However, participants might experience increased anxiety or frustration if they find the technology challenging.

R2D2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 8-12 years old and has been diagnosed with Type 1 Diabetes.
Select...
My child uses an insulin pump or multiple daily injections.

R2D2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
youth glycated hemoglobin (HbA1c)
youth time in range
Secondary outcome measures
Brief Resilience Scale
Diabetes Strengths and Resilience
Parent Problem Areas in Diabetes-Child (P-PAID-C)
+1 more

R2D2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: R2D2 mHealth treatment for diabetes distressExperimental Treatment1 Intervention
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
Group II: Standard Care ControlActive Control1 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).

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
124 Previous Clinical Trials
17,951 Total Patients Enrolled
Children's Mercy Hospital Kansas CityOTHER
245 Previous Clinical Trials
935,619 Total Patients Enrolled
Susana R Patton, PhDPrincipal InvestigatorNemours Children's Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to participate in this experimental study?

"The enrollment for this clinical research involves 180 individuals aged between 8 and 65 diagnosed with type 1 diabetes. Essential qualifications include a child's age falling within the range of 8-12 years, confirmation of T1D diagnosis by a healthcare professional, documentation showing distress levels equal to or exceeding clinical thresholds reported either by the child or parent (or both), and adherence to an intensive insulin treatment plan utilizing either pump delivery or multiple daily injections (MDI)."

Answered by AI

Is the enrollment process open for this medical study at present?

"As outlined on clinicaltrials.gov, this investigation is currently in search of suitable participants. The trial was introduced on February 23rd, 2024, and most recently revised on February 28th, 2024."

Answered by AI

What is the overall count of individuals participating in this medical study?

"Indeed, the details on clinicaltrials.gov reveal that this particular clinical study is actively seeking participants. Initially posted on February 23rd, 2024 and last modified on February 28th, 2024, the trial aims to enroll a total of 180 patients across two designated sites."

Answered by AI

Are individuals who are 85 years of age and older eligible to participate in this study?

"Participants aged 8 years and older but under the age of 65 are eligible for enrollment in this study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families
2024. "Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268250.
~120 spots leftby May 2025
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