R2D2 Program for Type 1 Diabetes

(R2D2 Trial)

Recruiting at 1 trial location

Overseen By Nicole Morales

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Must be taking: Intensive insulin

Disqualifiers: Conventional insulin, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 13 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help families manage stress related to Type 1 Diabetes (T1D) in school-age children by testing a mobile health (mHealth) program called the R2D2 mHealth intervention. The researchers seek to determine if reducing stress can improve blood sugar control. Participants will either try the new mHealth program or receive standard care with local resources. The trial is suitable for children aged 8-12 with T1D who experience significant stress about managing their condition and are on an intensive insulin regimen. As an unphased trial, it offers families the chance to explore innovative stress management strategies that could enhance their child's well-being.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it requires that children are on an intensive insulin regimen, so they must continue with their insulin treatment.

What prior data suggests that the R2D2 mHealth intervention is safe for treating diabetes distress?

Research has shown that e-health programs, such as the R2D2 mobile health program, are generally safe and user-friendly. A review of 41 studies involving 8,667 participants found that these digital treatments can significantly reduce diabetes-related stress without major safety issues. The program aims to assist families with school-age children in managing diabetes stress. No reports of serious side effects have emerged, indicating that the R2D2 program is a safe option for managing diabetes-related stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the R2D2 mHealth intervention for Type 1 Diabetes because it offers a fresh approach to managing diabetes distress. Unlike standard care, which typically involves providing families with local resources, this treatment uses a mobile health-supported cognitive behavioral therapy. This innovative method aims to directly engage both parents and children, making it more interactive and potentially more effective in addressing emotional challenges associated with diabetes. By leveraging technology, this approach could lead to more personalized and accessible support, helping families manage diabetes distress in a more targeted way.

What evidence suggests that the R2D2 mHealth intervention is effective for reducing diabetes distress in children with Type 1 Diabetes?

Research has shown that the R2D2 mobile health program, which participants in this trial may receive, holds promise in reducing stress for families with school-age children who have type 1 diabetes. Early results indicate that this digital tool effectively eases the stress of managing the disease. Families using the R2D2 program reported feeling less stressed, which is important because high stress can hinder blood sugar control. Although more information is needed, initial findings suggest that this program could improve overall well-being and possibly enhance blood sugar control in children with type 1 diabetes. ^{1 3 6 7 8}

Who Is on the Research Team?

Susana R Patton, PhD

Principal Investigator

Nemours Children's Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is between 8-12 years old and has been diagnosed with Type 1 Diabetes.

My child uses an insulin pump or multiple daily injections.

Either the child or the parent or both report diabetes distress levels at or above clinical cut-points

Exclusion Criteria

Children with an allergy or sensitivity to the adhesive and/or skin preparation used for CGM

My child is on a standard insulin treatment plan.

My child has a long-term health condition like kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive mHealth supported cognitive behavioral treatment for diabetes distress

13 weeks

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• R2D2 mHealth intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: R2D2 mHealth treatment for diabetes distress Experimental Treatment 1 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 Control Active Control 1 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).

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Children's Mercy Hospital Kansas City

Collaborator

Trials

261

Recruited

941,000+

Published Research Related to This Trial

A systematic review of 10 randomized clinical trials involving 2,209 participants found that e-Health technologies, such as Internet-Guided Self-Help and Telephone-Delivered Cognitive Behavioral Therapy (CBT), significantly improved depression and anxiety symptoms in individuals with diabetes.

The study demonstrated that these e-Health interventions also reduced diabetes-related emotional distress, indicating their potential effectiveness in enhancing mental health alongside diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-Health technologies for treatment of depression, anxiety and emotional distress in person with diabetes mellitus: A systematic review and meta-analysis. Tavares Franquez, R., Del Grossi Moura, M., Cristina Ferreira McClung, D., et al.[2023]

Participants in the Onduo Virtual Diabetes Clinic, a telehealth program for type 2 diabetes, experienced significant reductions in diabetes distress, with scores decreasing from 3.0 to 2.5 over an average of 6 months (P <0.001).

Those using real-time continuous glucose monitoring (rtCGM) reported even greater reductions in distress, particularly in regimen-related distress, highlighting the potential effectiveness of telemedicine and technology in managing diabetes-related emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Participation in a Virtual Diabetes Clinic on Diabetes-Related Distress in Individuals With Type 2 Diabetes. Polonsky, WH., Layne, JE., Parkin, CG., et al.[2021]

A systematic review of six studies involving 118 participants found that current interventions for disordered eating in people with Type 1 diabetes did not lead to significant improvements in glycaemic control (HbA1c levels).

Inpatient therapy, which included cognitive behavioral therapy, psychoeducation, and family therapy, showed the most promise, highlighting the need for more intensive and integrated approaches to address both disordered eating and diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of the efficacy of interventions for people with Type 1 diabetes mellitus and disordered eating. Clery, P., Stahl, D., Ismail, K., et al.[2018]

In a study of 72 participants with diabetes (18 with type 1 and 54 with type 2), diabetes-related distress significantly decreased in those with type 2 diabetes after intervention at a diabetes day care clinic, as measured by the PAID questionnaire.

Participants with type 2 diabetes also experienced significant improvements in HbA1c levels and body weight after the intervention, indicating that the program not only reduced distress but also improved metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of HbA1c and diabetes-related distress after intervention in a diabetes day care clinic in people with type 2 diabetes but not with type 1 diabetes. Kuniss, N., Müller, UA., Kloos, C., et al.[2022]

A systematic review of 41 studies involving 8,667 individuals found that e-health interventions significantly reduce diabetes distress in patients with type 2 diabetes (T2D), with a standardized mean difference of -0.14, indicating a meaningful clinical impact.

While e-health interventions also showed a reduction in depression among T2D patients, the effect was smaller and not statistically significant, with a standardized mean difference of -0.06.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are e-Health Interventions Effective in Reducing Diabetes-Related Distress and Depression in Patients with Type 2 Diabetes? A Systematic Review with Meta-Analysis. Fernández-Rodríguez, R., Zhao, L., Bizzozero-Peroni, B., et al.[2023]

This feasibility randomized controlled trial will assess the effectiveness of mobile health (mHealth) technology in enhancing a structured home-based exercise program for 120 individuals recently diagnosed with type 2 diabetes, aiming to improve adherence and communication with exercise specialists.

The study will evaluate primary outcomes such as recruitment rates and adherence to exercise over a 6-month period, potentially paving the way for more effective long-term physical activity strategies in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): protocol for a feasibility randomised controlled trial. Hesketh, K., Low, J., Andrews, R., et al.[2023]

Diabetes-tailored psychological interventions significantly reduce diabetes-distress, with a pooled effect size of 0.48, indicating a meaningful impact on individuals with Type 1 or Type 2 diabetes.

These interventions also lead to a reduction in HbA1c levels (effect size of 0.57), suggesting that addressing diabetes-distress can improve overall diabetes management, while mindfulness-based interventions showed minimal effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress. Schmidt, CB., van Loon, BJP., Vergouwen, ACM., et al.[2022]

In a study of 816 overweight/obese adults, those with type 2 diabetes or high blood sugar achieved similar weight loss results as those without these conditions while following a commercial weight-loss program with meal replacements and behavioral support.

Both groups experienced significant reductions in body fat, blood pressure, and abdominal circumference, indicating that the weight-loss program effectively improved cardiometabolic risk factors regardless of diabetes status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of a portion-controlled meal replacement program for weight loss in adults with and without diabetes/high blood sugar. Coleman, CD., Kiel, JR., Mitola, AH., et al.[2018]

The E-Supporter 1.0 digital coach was found to be an acceptable and user-friendly intervention for promoting a healthier lifestyle among 20 individuals with type 2 diabetes (T2D), with participants appreciating its motivational support and ease of use.

Participants showed significant improvements in daily step counts and self-efficacy levels after 9 weeks of using E-Supporter 1.0, although the intervention's impact on dietary behavior and the phase of behavior change was limited, indicating a need for further tailoring and evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Coach (E-Supporter 1.0) to Support Physical Activity and a Healthy Diet in People With Type 2 Diabetes: Acceptability and Limited Efficacy Testing. Hietbrink, EAG., Oude Nijeweme-d'Hollosy, W., Middelweerd, A., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11506446/

Early Results of an Innovative Scalable Digital Treatment for ...

This paper reports on the initial outcomes of a new mHealth intervention to reduce diabetes distress (DD) in families of school-age children living with type 1 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05268250

Remedy to Diabetes Distress (R2D2): A Scalable Screen to ...

The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in ...

3.

withpower.com

withpower.com/trial/phase-type-1-diabetes-mellitus-6-2022-709ee

R2D2 Program for Type 1 Diabetes (R2D2 Trial)

Trial Overview 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, ...

4.

app.dimensions.ai

app.dimensions.ai/details/grant/grant.9412247

A Scalable Screen to Treat Program for School-Age Families

PROJECT SUMMARY While ~25% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of <7.5%, the majority of school-age children do not and are ...

5.

researchgate.net

researchgate.net/publication/384394226_Early_Results_of_an_Innovative_Scalable_Digital_Treatment_for_Diabetes_Distress_in_Families_of_School-Age_Children_with_Type_1_Diabetes

Early Results of an Innovative Scalable Digital Treatment ...

Objective: This paper reports on the initial outcomes of a new mHealth intervention to reduce diabetes distress (DD) in families of school-age ...

6.

mdpi.com

mdpi.com/2227-9067/11/10/1169

Early Results of an Innovative Scalable Digital Treatment ...

Conclusions​​ In sensitivity analyses, results suggest R2D2 could particularly benefit families experiencing higher levels of distress and/or ...

7.

reporter.nih.gov

reporter.nih.gov/project-details/10896468

Remedy to Diabetes Distress (R2D2) - NIH RePORTER

Our objective is to test the feasibility and acceptability of a novel, practical, and scalable screen-to-treat program for DD in school-age children and their ...

8.

pediatrics.jmir.org

pediatrics.jmir.org/2025/1/e66914

Empowering Caregiver Well-Being With the Adhera Caring ...

This study aims to assess how the ACDP influences caregivers' mood, emotional well-being, and health-related quality of life within the context of T1D.