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Biobehavioral Human-Machine Co-adaptation of the Artificial Pancreas

Award Number: R01DK085623
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: 09/28/2009
PERIOD OF PERFORMANCE END DATE: 03/31/2025

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Biobehavioral Human-Machine Co-adaptation of the Artificial Pancreas - PROJECT SUMMARY Biobehavioral Human-Machine Co-adaptation of the Artificial Pancreas Closed-loop control (CLC) is now transitioning to the clinical practice and one of the most advanced systems to date–Control-IQ–uses an algorithm designed and tested by the previous research cycle of this project. With the first generation of our CLC system now translated to the clinic, our objective is to design and test next-generation CLC solutions, learning from the experience and utilizing the large database accumulated to date. Thus, we focus this project on the new concept of Adaptive Biobehavioral Control (ABC) – a first-in-class system that will use human-machine co-adaptation of CLC, recognizing both the necessity for the control algorithm to adapt to changes in human physiology, and the necessity for the person to adapt to CLC action. To achieve its objectives, the ABC system will have two new components added to the current state-of-the art Control-IQ: a Behavioral Adaptation Module (BAM) – a behavioral intervention deployed in a mobile app to assist a person's adaptation to CLC by information and risk assessment primarily regarding meals and physical activity, and a Physiologic Adaptation Module (PAM) – an automated procedure tracking risk status and changes in the user's metabolic profile and acting in real time to adapt the CLC algorithm's insulin control parameters. Using these technologies, we now propose to compare, in a randomized cross-over trial enrolling 90 participants with type 1 diabetes, the current CLC (Control-IQ) to three new treatment modalities: ABC and its components BAM and PAM. To do so, study participants will be randomized to two groups following two different sequences of treatment modalities: CLCCLC+BAMCLC+PAMABC and ABCCLC+PAMCLC+BAMCLC. Each treatment modality will continue for 2 months and the treatments will be separated by 2-week washout periods. This design was used successfully in our previous study and enables four crossover comparisons: CLC vs. ABC (primary) and CLC+BAM vs. CLC; CLC+PAM vs. ABC; CLC+BAM vs. CLC+PAM (secondary). We expect that: (1) ABC will be superior to the current CLC in terms of: improved time in the target range 70-180mg/dl measured by continuous glucose monitoring (CGM); reduced risk for hypoglycemia, and better technology acceptance; (2) Behavioral adaptation (CLC+BAM) will be superior to CLC in terms of improved CGM-measured time in the target range during the day and reduced CGM-measured incidence of hypoglycemia during/after exercise; (3) Physiologic adaptation (CLC+PAM) will account for most of the glycemic benefits of ABC overnight, will be inferior to BAM in terms of postprandial glucose variability and hypoglycemia during/after exercise, and will be superior to BAM in terms of technology acceptance for those who prefer fully-automated control. Overall, we affirm that reliable technology has been developed and sufficient data accumulated to warrant the development of next-generation biobehavioral control, aiming adaptation of user behavior to the specifics of CLC treatment and adaptation of CLC technology to user physiology, separately and in combination. The proposed project will design and test a system for monitoring and control of these adaptation processes.


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: 2024 ( Subtotal = $672,513 )
2024	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	14	5/20/2024	NON-COMPETING CONTINUATION	$42,031
2024	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	14	4/5/2024	NON-COMPETING CONTINUATION	$630,482
														Subtotal = $672,513

Issue Date FY: 2023 ( Subtotal = $700,249 )
2023	2023	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	13	3/23/2023	NON-COMPETING CONTINUATION	$700,249
														Subtotal = $700,249

Issue Date FY: 2022 ( Subtotal = $700,539 )
2022	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	12	4/26/2022	NON-COMPETING CONTINUATION	$700,539
2022	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	10	4/20/2022	COMPETING CONTINUATION	$134
2022	2018	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	3/24/2022	NON-COMPETING CONTINUATION	$0
2022	2018	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	4/20/2022	NON-COMPETING CONTINUATION	-$134
														Subtotal = $700,539

Issue Date FY: 2021 ( Subtotal = $700,025 )
2021	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	11	3/31/2021	NON-COMPETING CONTINUATION	$700,025
2021	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	3/5/2021	COMPETING CONTINUATION	$0
														Subtotal = $700,025

Issue Date FY: 2020 ( Subtotal = $700,954 )
2020	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	6/22/2020	COMPETING CONTINUATION	$700,954
2020	2018	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	9	9/26/2020	NON-COMPETING CONTINUATION	$0
2020	2018	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	6/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $700,954

Issue Date FY: 2018 ( Subtotal = $702,686 )
2018	2018	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	2/14/2018	NON-COMPETING CONTINUATION	$632,417
2018	2018	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	4/30/2018	NON-COMPETING CONTINUATION	$70,269
														Subtotal = $702,686

Issue Date FY: 2017 ( Subtotal = $701,375 )
2017	2017	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	6/14/2017	NON-COMPETING CONTINUATION	$70,139
2017	2017	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	3/6/2017	NON-COMPETING CONTINUATION	$631,236
														Subtotal = $701,375

Issue Date FY: 2016 ( Subtotal = $700,390 )
2016	2016	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	3/4/2016	NON-COMPETING CONTINUATION	$700,390
														Subtotal = $700,390

Issue Date FY: 2015 ( Subtotal = $698,995 )
2015	2015	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	2/10/2015	COMPETING CONTINUATION	$698,995
2015	2013	UNIVERSITY OF VIRGINIA	PO BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	2/6/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $698,995

Issue Date FY: 2014 ( Subtotal = $18,516 )
2014	2013	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	12/10/2013	NON-COMPETING CONTINUATION	$9,006
2014	2012	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	12/10/2013	NON-COMPETING CONTINUATION	$9,510
														Subtotal = $18,516

Issue Date FY: 2013 ( Subtotal = $636,768 )
2013	2013	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	12/10/2013	NON-COMPETING CONTINUATION	$9,006
2013	2013	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	8/21/2013	NON-COMPETING CONTINUATION	$627,762
														Subtotal = $636,768

Issue Date FY: 2012 ( Subtotal = $661,306 )
2012	2012	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/23/2012	NON-COMPETING CONTINUATION	$661,306
														Subtotal = $661,306

Issue Date FY: 2011 ( Subtotal = $741,698 )
2011	2011	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/29/2011	NON-COMPETING CONTINUATION	$741,698
														Subtotal = $741,698

Issue Date FY: 2010 ( Subtotal = $748,089 )
2010	2010	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	8/31/2010	NON-COMPETING CONTINUATION	$748,089
2010	2009	UNIVERSITY OF VIRGINIA	PO BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	11/17/2009	NEW	$0
														Subtotal = $748,089

Issue Date FY: 2009 ( Subtotal = $730,673 )
2009	2009	UNIVERSITY OF VIRGINIA	P.O. BOX 400195	CHARLOTTESVILLE	VA	22904	CHARLOTTESVILLE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/23/2009	NEW	$730,673
														Subtotal = $730,673

Grand Total All Awards = $9,814,776

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Biobehavioral Human-Machine Co-adaptation of the Artificial Pancreas

Award Number: R01DK085623

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: 09/28/2009

PERIOD OF PERFORMANCE END DATE: 03/31/2025

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