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Effectiveness Trial to Support Adoption of Hybrid Closed Loop Therapy in Underserved Adults with Type 1 Diabetes: Impact of System Functionality and Features on Lived Experience

Award Number: R01DK138309
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: 01/01/2024
PERIOD OF PERFORMANCE END DATE: 12/31/2028

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Effectiveness Trial to Support Adoption of Hybrid Closed Loop Therapy in Underserved Adults with Type 1 Diabetes: Impact of System Functionality and Features on Lived Experience - Individuals with type 1 diabetes (T1D) from certain ethnic/racial minority and lower socio-economic groups have higher average A1c levels and rates of hospitalizations, complications, and mortality than the general T1D population. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in patients who have greater access to medical support. More automated systems could potentially better match the needs of individuals from medically underserved communities (defined as lower socio-economic status, ethnic/minority groups and rural populations) with competing life demands that limit diabetes self-care; however, the potential benefits of automation are at the cost of less personal control of the system, including adjustments for work-shift changes and activity. To address disparities in the prevalence, access to medical care, and the effectiveness of HCL systems, three Specific Aims are proposed. In Specific Aim 1 we plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer (9 month) follow up than the pivotal HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in adults with T1D-related health disparities. Primary outcome will be % time-in-range 70-180 mg/dL, and secondary outcomes will include % time < 70 mg/dL, DKA events and body weight. The HCL arm in the trial will include three HCL systems (BetaBionics iLet, Insulet OP 5, Tandem Control IQ) that vary in degree of automation and user input required for operation. Specific Aim 2 incorporates the novel application of Ecological Momentary Assessment to examine the lived experience with HCL (including benefits and burdens, the impact of life stressors impact on HCL use, and how the match between HCL system functionality and the individual’s needs and expectations impacts on user experience). In Specific Aim 3, in collaboration with a user-centered designer, we will apply the learnings from the study to develop: 1) Improved HCL patient education and clinician support tools; and 2) Decision-aids to guide patient selection of the HCL system that is most aligned with personal preferences and needs. These optimized training materials and decision-aids will set the stage for the translation of our research findings into broader adoption of HCL in primary care and improved shared decision-making by patients and clinicians in the selection of HCL systems.


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: 2026 ( Subtotal = $844,525 )
2026	2026	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/28/2026	NON-COMPETING CONTINUATION	$844,525
														Subtotal = $844,525

Issue Date FY: 2025 ( Subtotal = $854,975 )
2025	2025	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/19/2024	NON-COMPETING CONTINUATION	$854,975
														Subtotal = $854,975

Issue Date FY: 2024 ( Subtotal = $899,996 )
2024	2024	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	4/1/2024	NEW	$0
2024	2024	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/29/2023	NEW	$899,996
														Subtotal = $899,996

Grand Total All Awards = $2,599,496

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Effectiveness Trial to Support Adoption of Hybrid Closed Loop Therapy in Underserved Adults with Type 1 Diabetes: Impact of System Functionality and Features on Lived Experience

Award Number: R01DK138309

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: 01/01/2024

PERIOD OF PERFORMANCE END DATE: 12/31/2028

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