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Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults with T1D

Award Number: R01DK129479
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: 08/25/2021
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults with T1D - PROJECT SUMMARY/ABSTRACT Adolescents and young adults (AYA) with type 1 diabetes (T1D) are especially at risk for missed diabetes visits and suboptimal self-care behaviors, as evidenced by their poor glycemic control with very high A1c levels. Further, diabetes distress is common in AYA with T1D and contributes to their suboptimal self-care behaviors and outcomes. The American Diabetes Association (ADA) recommends routine screening for diabetes distress and, when identified, referral for diabetes education or mental health treatment. Persons experiencing diabetes distress are at increased risk for missed medical appointments and deficient diabetes self-management. This is concerning because, without intervention, diabetes distress does not remit and either remains stable or intensifies over time. Further, AYAs may not adequately access or use advanced diabetes technologies due to perceptions of possible increases in self-care burden and diabetes distress when, in fact, such technologies could aid in their efforts to enhance self-care and improve glycemic control. Thus, there is an urgent need to develop practical and widely accessible interventions that target diabetes distress, self-care, and glycemic control and include face-to-face and remote visits to facilitate uptake. In the proposed 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress, increase acceptance of self-care behaviors (with or without diabetes technologies), and improve glycemic outcomes in AYAs with T1D. As a group, AYAs with T1D represent the subpopulation of all persons with T1D across the lifespan that has the poorest glycemic control, reaching a peak mean A1c value >9% at age ~19. AYAs with T1D often experience diabetes distress, which is linked to poor glycemic control, making them ideal participants for the proposed study. We will recruit 180 AYAs (ages 14-25) with T1D duration of at least 1 year and suboptimal diabetes control (A1c 8-13%). Participants will be randomly assigned to a usual care control condition or the intervention group. The intervention group will participate in monthly intervention sessions with a study interventionist during the first year. Of the monthly sessions, 4 will focus on improving glycemic outcomes in face-to-face sessions and 8 will focus on reducing diabetes distress in remote, virtual sessions to limit study burden (and in recognition of paradigm changes in care delivery during SARS- CoV-2 pandemic). To ensure adequate recruitment and retention, the control group will receive a delayed intervention and participate in the monthly sessions during the second year of the study. Both groups will use continuous glucose monitoring (CGM) for 14 days every 3 months and complete surveys every 6 months. A1c will also be measured centrally every 6 months. We will compare the two groups on the primary glycemic outcome of percent time-in-range (TIR) of 70-180 mg/dL assessed by CGM and on the secondary outcomes of diabetes distress and A1c from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent TIR, diabetes distress, and A1c compared with the usual care control group.


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	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/31/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $780,793 )
2024	2024	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	4	8/1/2024	SUPPLEMENT FOR EXPANSION	$119,527
2024	2024	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	7/31/2024	NON-COMPETING CONTINUATION	$646,831
2024	2023	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	11/6/2023	SUPPLEMENT FOR EXPANSION	$14,435
														Subtotal = $780,793

Issue Date FY: 2023 ( Subtotal = $792,319 )
2023	2023	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	8/30/2023	SUPPLEMENT FOR EXPANSION	$105,034
2023	2023	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/2/2023	NON-COMPETING CONTINUATION	$687,285
														Subtotal = $792,319

Issue Date FY: 2022 ( Subtotal = $704,934 )
2022	2022	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	8/1/2022	NON-COMPETING CONTINUATION	$702,590
2022	2021	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/13/2022	NEW	$2,344
														Subtotal = $704,934

Issue Date FY: 2021 ( Subtotal = $725,398 )
2021	2021	JOSLIN DIABETES CENTER, INC.	1 JOSLIN PL	BOSTON	MA	02215	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/25/2021	NEW	$725,398
														Subtotal = $725,398

Grand Total All Awards = $3,003,444

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Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults with T1D

Award Number: R01DK129479

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: 08/25/2021

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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