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One year day-and-night home closed loop in young people with type 1 diabetes

Award Number: UC4DK108520
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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DESCRIPTION (provided by applicant): Our previous randomized clinical trials evaluated closed loop insulin delivery in over 120 subjects under FREE-LIVING UNSUPERVISED HOME settings in studies lasting 1 WEEK to 3 MONTHS (total closed loop operation 81,120 hours/3,380days/9.3 years). All studies used CAMBRIDGE model predictive control algorithm. We demonstrated the safety, efficacy, and acceptability of closed loop insulin delivery over short to medium long investigations. However, performance over prolonged period is unknown and is of interest particularly in young subjects given failure of other approaches to improve outcomes. The present project addresses the important question of LONG TERM closed loop use and will apply an Android-phone closed loop system directing insulin delivery by a next generation insulin pump. The system will be configured to protect against HYPOGLYCAEMIA in case of closed loop not being temporarily operational for reasons such as limited component connectivity. Specifically, we will evaluate the performance of 12 MONTH 24/7 CLOSED LOOP in CHILDREN AND ADOLESCENTS aged 6 to 18 years with type 1 diabetes under FREE-LIVING UNSUPERVISED HOME SETTINGS. We will use closed loop system comprising 640G PUMP and ENLITE 3 sensor (both Medtronic) and an Android phone running CAMBRIDGE MODEL PREDICTIVE CONTROL ALGORITHM. The system SAFETY will be ENHANCED by the use of predictive low glucose management, INTEGRATED on 640G pump, and suspending insulin delivery when hypoglycaemia is predicted even when Android-driven closed loop is not operating. In total, 130 PARTICIPANTS will be randomised to undergo either 24/7 closed loop or sensor augmented insulin pump therapy (65 participants in each group). The study will compare BIOMEDICAL, PSYCHOSOCIAL, and COST-EFFECTIVENESS of the two study interventions. HbA1c measured in central laboratory will be the primary endpoint. Biomedical outcomes (mean glucose, time in/above/below target and other related glucose/insulin metrics) will be complemented by assessments of psychosocial/human factors issues (focus groups and questionnaires) and cost utility analysis. The project will provide information to facilitate pivotl studies leading to REGULATORY APPROVAL, COMMERCIALISATION, AND REIMBURSEMENT of 24/7 closed-loop control.


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: 2022 ( Subtotal = -$674,478 )
2022	2015	THE CHANCELLOR, MASTERS, AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE	UNIVERSITY OF CAMBRIDGE THE OLD SCHOOLS, TRINITY LANE	CAMBRIDGE				GBR	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/1/2021	NEW	-$674,478
														Subtotal = -$674,478

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2015	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE	THE OLD SCHOOLS	CAMBRIDGE	CAMBRIDGESHIRE			GBR	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/15/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2015	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE	THE OLD SCHOOLS	CAMBRIDGE	CAMBRIDGESHIRE	CB2 1TN		GBR	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/21/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2015	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE	THE OLD SCHOOLS	CAMBRIDGE	CAMBRIDGESHIRE	CB2 1TN		GBR	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/14/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = -$16,000 )
2017	2015	THE CHANCELLOR, MASTER AND SCHOLARS OF THE UNIVERISTY OF CAMBRIDGE	THE OLD SCHOOLS	CAMBRIDGE	CAMBRIDGESHIRE	CB2 1TN		GBR	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/6/2016	NEW	-$16,000
														Subtotal = -$16,000

Issue Date FY: 2015 ( Subtotal = $6,360,942 )
2015	2015	UNIVERSITY OF CAMBRIDGE	Free School Lane	CAMBRIDGE				GBR	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/22/2015	NEW	$6,360,942
														Subtotal = $6,360,942

Grand Total All Awards = $5,670,464

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One year day-and-night home closed loop in young people with type 1 diabetes

Award Number: UC4DK108520

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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