Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05268250 |
| Other study ID # |
1687888 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 23, 2024 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Nemours Children's Clinic |
| Contact |
Susana R Patton, PhD |
| Phone |
9046972000 |
| Email |
susana.patton[@]nemours.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Only 22% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of <7.5% while
the majority of school-age children who exceed this target are at higher risk for T1D-related
complications. Achieving optimal T1D self-care is the only direct pathway to better HbA1c and
even with the addition of modern therapeutic modalities (e.g., hybrid closed loop), it is a
complex, time-consuming, and relentless task. School-age children cannot effectively manage
T1D alone and require help from their parents to participate in daily T1D self-care. The
research suggests that both parents and youth with T1D are vulnerable to Diabetes Distress
(DD) and the American Diabetes Association (ADA) Standards of Care recommend ongoing
assessment of DD in youth (starting at 7-8-years-old) and their caregiver during routine
diabetes clinic visits. Unfortunately, while DD screening may be an ADA Care Standard, there
are no practical treatment options for clinics to adopt to treat DD in school-age families in
the case of positive screens. The researchers submit this new R01 in response to
RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes.
Our objective is to test the feasibility and acceptability of a novel, practical, and
potentially scalable screen to treat program for DD in families of school-age children with
T1D (called Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to
reduce DD to improve children's glycemic control. To enhance scientific rigor, the
researchers plan to use the ORBIT model for behavioral intervention development to guide the
study design. The specific aims are: 1) Define feasibility and acceptability of our new
screen to treat program (R2D2) for DD in school-age families, and 2) Establish initial
efficacy of R2D2 to reduce parent and child DD to improve child glycemic control. The
researchers propose to address these Aims through an iterative process and multiple projects
to complete the necessary formative research to design, build, and prepare to implement R2D2.
The researchers then propose to complete a Pilot randomized controlled trial of their R2D2
screen to treat program, testing for its initial efficacy based on child HbA1c and time in
range (primary outcomes) and parent and child DD and resilience, and T1D self-care (secondary
outcomes; Phase 2b: Pilot, n=180). The impact of the proposed R01 is high because it
addresses a critical need for practical and evidence-based solutions for screening and
treating DD in families of school-age children, heretofore an understudied patient subgroup.
The researchers believe our study optimally responds to the FOA because the research team is
multidisciplinary (anchored by a partnership between behavioral science and diabetology), and
their R2D2 screen to treat program reflects a practical team approach that can realistically
occur in clinic and scale to other centers.
