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Type 1 Diabetes TrialNet: Toronto Clinical Center

Award Number: U01DK107013
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/20/2015
PERIOD OF PERFORMANCE END DATE: 04/30/2020

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Type 1 Diabetes TrialNet: Toronto Clinical Center - DESCRIPTION (provided by applicant): Despite effective current therapies for Type 1 diabetes (T1D), significant risks of long term complications of diabetes exist. Multiple studies have demonstrated that autoimmunity associated with type 1 diabetes is found years before its clinical presentation and that T1D can be predicted. The goals of the Type 1 Diabetes TrialNet Study Group are to prevent loss of beta cells through study of the pathogenesis of T1D and trials of therapies to intervene in the process. To reach TrialNet's goal, successful Clinical Centers must maintain and develop highly effective recruitment approaches, encourage participation of subjects in follow up and prevention studies and carry out studies in a highly efficient and accurate manner. In addition, they must contribute to the overall mission by engagement in TrialNet activities and committees and adding clinical and/or scientific expertise. The aims of this application reflect our center's approach to meeting TrialNet's mission: • To describe the progress and function of the Toronto Clinical Center as an innovative and effective TrialNet site that has developed an extensive regional and national network with broad links in the diabetes community. As a result, our site ranks 5th of 18 Clinical Centers in the number of subjects enrolled in screening and monitoring phases of the Pathway to Prevention study with a very high retention rate of over 90%. Careful analysis of the effectiveness of recruitment approaches through the use of reports from TrialNet's Coordinating Center and data collected by our site has allowed us to optimize efforts yielding an increase in the number of subjects screened for the Pathway to Prevention Study over the past 3 years. • To illustrate leadership and collaborative roles in TrialNet efforts such as Dr. Wherrett's leadership of the Study of Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects Study, management of all Canadian regulatory requirements for our site and the Canadian Affiliate Network, and our coordinators' roles in developing materials to support recruitment. • To highlight approaches used to assist Affiliate Sites with training and specialized support such as screening event identification and development. Methods to enhance recruitment and cost efficiency through new links, optimize efficiency of IRB review through the development of shared tools for review and consent documents, monitor the success of recruitment efforts and study conduct are detailed. A proposal for a fellowship to support new clinical researchers in type 1 diabetes is described.


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: 2020 ( Subtotal = $0 )
2020	2018	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	9/12/2020	NON-COMPETING CONTINUATION	$0
2020	2018	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	11/27/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $447,120 )
2018	2018	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	6/22/2018	NON-COMPETING CONTINUATION	$176,467
2018	2018	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/18/2018	NON-COMPETING CONTINUATION	$270,653
														Subtotal = $447,120

Issue Date FY: 2017 ( Subtotal = $437,393 )
2017	2017	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	6/21/2017	NON-COMPETING CONTINUATION	$43,738
2017	2017	HOSPITAL FOR SICK CHILDREN, THE	555 UNIVERSITY AVE	TORONTO	ON	M5G 1X8		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/28/2017	NON-COMPETING CONTINUATION	$393,655
														Subtotal = $437,393

Issue Date FY: 2016 ( Subtotal = $437,394 )
2016	2016	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	5/2/2016	NON-COMPETING CONTINUATION	$437,394
														Subtotal = $437,394

Issue Date FY: 2015 ( Subtotal = $437,394 )
2015	2015	HOSPITAL FOR SICK CHILDREN, TORONTO	555 UNIVERSITY AVENUE	TORONTO, ONTARIO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/20/2015	NEW	$437,394
														Subtotal = $437,394

Grand Total All Awards = $1,759,301

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Type 1 Diabetes TrialNet: Toronto Clinical Center

Award Number: U01DK107013

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/20/2015

PERIOD OF PERFORMANCE END DATE: 04/30/2020

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