R2D2 Program for Type 1 Diabetes

(R2D2 Trial)

Recruiting at 1 trial location

Overseen By Amy Milkes

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

Trial Summary

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 data supports the effectiveness of the R2D2 mHealth intervention treatment for Type 1 Diabetes?

Research shows that e-health interventions, which are similar to the R2D2 mHealth intervention, can effectively reduce diabetes-related distress in people with diabetes. This suggests that the R2D2 program might also help in managing emotional stress related to diabetes. ^{1 2 3 4 5}

How is the R2D2 mHealth intervention treatment for Type 1 Diabetes different from other treatments?

The R2D2 mHealth intervention is unique because it uses mobile health technology to address diabetes-related distress, which is a common emotional challenge for people with Type 1 Diabetes. Unlike traditional treatments that focus solely on blood sugar control, this intervention aims to improve emotional well-being through digital support. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Susana R Patton, PhD

Principal Investigator

Nemours Children's Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress. [2022]

3. Ireland 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Participation in a Virtual Diabetes Clinic on Diabetes-Related Distress in Individuals With Type 2 Diabetes. [2021]

5. England 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. [2018]

6. Germany 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. [2022]

7. Canada 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. [2023]

8. England 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. [2018]

9. England 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. [2023]