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

Award Number: R01DK127493
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Remedy to Diabetes Distress (R2D2): 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 at a higher risk for T1D-related complications. Achieving optimal T1D self- care is currently the only direct pathway to better HbA1c and even with the addition of modern therapeutic modalities (e.g., hybrid closed loop), T1D self-care is a complex, time-consuming, and relentless task. School- age children need support from their parents to effectively manage T1D and therefore both parents and youth with T1D are vulnerable to Diabetes Distress (DD). Presently, the American Diabetes Association (ADA) Standards of Care recommend assessment of DD during routine diabetes clinic visits in youth and their caregivers starting when youth are ~8-years-old. Unfortunately, while DD screening may be an ADA Care Standard, there are no practical and evidence-based screen-to-treat programs for clinics to adopt to meet this Standard of Care. We 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 scalable screen-to-treat program for DD in school-age children and their parents (called Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to reduce DD to improve children's glycemic control. Our specific aims are: 1) Define and iteratively refine our new screen-to-treat program (R2D2) for DD in school-age families in order to maximize feasibility and acceptability to stakeholders, and 2) Establish initial efficacy of R2D2 to reduce parent and child DD to improve child glycemic control. To enhance scientific rigor, we will use the ORBIT Model for Behavioral Intervention Development to guide our study design. The ORBIT Model proposes a phased approach using a series of small, cost-effective studies to determine clinically- meaningful targets and to test a treatment's acceptability and initial efficacy before embarking on a large clinical trial. For ORBIT Phase 1a: Define, we will conduct a brief longitudinal study to establish cut-points for clinically relevant DD in parents and school-age children, engage clinic Quality Improvement teams to develop a practical clinic-based screening approach, and use crowdsourcing techniques to obtain family input on a new mHealth treatment. For ORBIT Phase 1b: Refine, we will test implementation of our R2D2 screening program across multiple clinics and we will conduct a small trial to identify an initially efficacious and practical mHealth treatment delivery approach for R2D2. Finally, for ORBIT Phase 2a, we will continue to screen for DD in clinic and recruit families who report clinically relevant DD into a Proof of Concept Pilot to examine whether ameliorating parent and/or child DD leads to improved child glycemic control. We believe our study optimally responds to the FOA because our: 1-research team is multidisciplinary and includes a true partnership between a behavioral scientist and a diabetologist, 2-R2D2 screen-to-treat program reflects a practical approach that could realistically occur in clinic, 3-use of Implementation Science will further enhance future sustainability and dissemination of R2D2.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THE NEMOURS FOUNDATION	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	8/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $619,440 )
2024	2024	THE NEMOURS FOUNDATION	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	8/22/2024	NON-COMPETING CONTINUATION	$619,440
														Subtotal = $619,440

Issue Date FY: 2023 ( Subtotal = $627,155 )
2023	2023	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/31/2023	NON-COMPETING CONTINUATION	$627,155
														Subtotal = $627,155

Issue Date FY: 2022 ( Subtotal = $633,694 )
2022	2022	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/18/2022	NON-COMPETING CONTINUATION	$633,694
														Subtotal = $633,694

Issue Date FY: 2021 ( Subtotal = $648,020 )
2021	2021	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/18/2021	NON-COMPETING CONTINUATION	$648,020
														Subtotal = $648,020

Issue Date FY: 2020 ( Subtotal = $672,233 )
2020	2020	NEMOURS FOUNDATION, THE	807 CHILDRENS WAY	JACKSONVILLE	FL	32207	DUVAL	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2020	NEW	$672,233
														Subtotal = $672,233

Grand Total All Awards = $3,200,542

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

Award Number: R01DK127493

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/05/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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