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Sleep for Health: A randomized clinical trial examining the effects of cognitive behavioral therapy for insomnia on diabetes risk

Award Number: R01DK132229
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: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Sleep for Health: A randomized clinical trial examining the effects of cognitive behavioral therapy for insomnia on diabetes risk - PROJECT SUMMARY/ABSTRACT Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected that one in three Americans will have T2D by 2050. To stem the tide of this health crisis, new strategies are needed to prevent the progression to T2D from prediabetes—elevated glucose levels that are not yet in the diabetes range. A growing body of research suggests that insomnia is a major modifiable risk factor for progression to diabetes. The proposed study would build off a promising feasibility study to test whether providing cognitive behavioral therapy for insomnia (CBT-I) to patients with prediabetes results in a reduction in glucose levels compared to a patient education control program. If so, this insomnia treatment could be an effective tool to prevent diabetes. Individuals with prediabetes and insomnia will be randomized to receive six sessions of a deployment-ready digital CBT-I program, providing standard-of-care treatment for insomnia (intervention arm, n = 150), or a patient education website providing nontailored educational material about insomnia (control arm, n = 150). We will complete assessments at baseline, at 10 weeks (after the conclusion of the intervention and control programs), and at 32 weeks post-baseline, measuring hyperglycemia, objective and subjective measures of sleep, and potential mediating variables including diet, exercise, and mood. We will also collect and store blood samples to allow for assessment of metabolic mechanisms in future research. We will assess (1) whether individuals randomized to the intervention arm have lower rates of hyperglycemia, as measured by oral glucose tolerance testing and various secondary measures, than individuals randomized to the control arm at 10 weeks and 32 weeks after baseline; (2) whether improvements in sleep after baseline are associated with decreases in hyperglycemia, regardless of study arm; and (3) whether any effects of the intervention on hyperglycemia are mediated by improvements in sleep, diet, exercise, and/or mood. This research will serve as a critical step in identifying a potentially dramatic tool for improving health outcomes for Americans at risk of T2D. Sleep interventions can lead to sustained improvements that are intrinsically rewarding to patients. If effective, digital CBT-I could provide a powerful pathway to preventing diabetes for millions of patients with prediabetes.


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 = $703,883 )
2026	2026	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	2/26/2026	NON-COMPETING CONTINUATION	$703,883
														Subtotal = $703,883

Issue Date FY: 2025 ( Subtotal = $702,229 )
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	6/30/2025	NON-COMPETING CONTINUATION	$70,222
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	2/19/2025	NON-COMPETING CONTINUATION	$632,007
														Subtotal = $702,229

Issue Date FY: 2024 ( Subtotal = $674,411 )
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/12/2024	NON-COMPETING CONTINUATION	$632,261
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/6/2024	NON-COMPETING CONTINUATION	$42,150
														Subtotal = $674,411

Issue Date FY: 2023 ( Subtotal = $702,822 )
2023	2023	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/31/2023	NEW	$702,822
														Subtotal = $702,822

Grand Total All Awards = $2,783,345

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Sleep for Health: A randomized clinical trial examining the effects of cognitive behavioral therapy for insomnia on diabetes risk

Award Number: R01DK132229

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: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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