This application is submitted in response to the RFA for a Data Coordinating Center (DCC) to serve the needs of the Cooperative Multicenter Diabetes Research Network for Hypoglycemia Prevention. The network is expected to include five clinical centers (CCs) and a central laboratory. The main objective of this network will be to advance the field of hypoglycemia prevention in patients with type 1 diabetes through the conduct of multi-center clinical protocols that investigate the safety and efficacy of treatment and management strategies. The role of the DCC in a multi-center project such as this one is key to its success. As will be evident, we have a clear understanding of the project's goals and scope, and we recognize its importance and potential public health impact. As it is not the purpose of the DCC application to justify the need for this research or to propose a specific protocol, this proposal will focus on the capabilities of the Jaeb Center to serve as the DCC for the project. For essentially all aspects of the project, we will draw upon our experience from our role as the DCC for the Diabetes Research in Children Network (DirecNet) and our other prior and current studies. As the current DirecNet DCC, we have a coordinating center already in place to provide for a seamless transition into phase 2 of DirecNet. Through DirecNet and the other multi-center projects we have directed, we have experience with all of the DCC functions and responsibilities this project will entail. Importantly, we have considerable experience with networks that conduct multiple concurrent and sequential protocols, which has been a strong feature of DirecNet to date, and through participation in DirecNet, we have extensive experience in studies of type 1 diabetes in children, including the data management of and analysis of continuous glucose monitoring data. As will be apparent, we have been innovative in our approach to clinical trial conduct and management and have relied extensively on using the Internet not only to increase efficiency, but also to enhance quality control measures. We believe we have been very successful as the DCC for phase 1 of DirecNet as evidenced by the number of protocols that have been conducted and the number of manuscripts that have been published. In this application, we will highlight the accomplishments of DirecNet in phase 1 and the capabilities of the Jaeb Center to continue as the DCC for phase 2. We believe that our track record as the DCC in phase 1 overwhelmingly justifies our continuing as the DCC in phase 2.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Application #
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (20))
Program Officer
Winer, Karen
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Jaeb Center for Health Research, Inc.
United States
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Triolo, Taylor M; Maahs, David M; Pyle, Laura et al. (2016) Effects of Frequency of Sensor-Augmented Pump Use on HbA1c and C-Peptide Levels in the First Year of Type 1 Diabetes. Diabetes Care 39:e61-2
DiMeglio, Linda A; Cheng, Peiyao; Beck, Roy W et al. (2016) Changes in beta cell function during the proximate post-diagnosis period in persons with type 1 diabetes. Pediatr Diabetes 17:237-43
Bischoff, Allison N; Reiersen, Angela M; Buttlaire, Anna et al. (2015) Selective cognitive and psychiatric manifestations in Wolfram Syndrome. Orphanet J Rare Dis 10:66
Buckingham, Bruce; Cheng, Peiyao; Beck, Roy W et al. (2015) CGM-measured glucose values have a strong correlation with C-peptide, HbA1c and IDAAC, but do poorly in predicting C-peptide levels in the two years following onset of diabetes. Diabetologia 58:1167-74
Englert, Kimberly; Ruedy, Katrina; Coffey, Julie et al. (2014) Skin and adhesive issues with continuous glucose monitors: a sticky situation. J Diabetes Sci Technol 8:745-51
Cato, M Allison; Mauras, Nelly; Ambrosino, Jodie et al. (2014) Cognitive functioning in young children with type 1 diabetes. J Int Neuropsychol Soc 20:238-47
Barnea-Goraly, Naama; Weinzimer, Stuart A; Ruedy, Katrina J et al. (2014) High success rates of sedation-free brain MRI scanning in young children using simple subject preparation protocols with and without a commercial mock scanner--the Diabetes Research in Children Network (DirecNet) experience. Pediatr Radiol 44:181-6
Arbelaez, Ana Maria; Xing, Dongyuan; Cryer, Philip E et al. (2014) Blunted glucagon but not epinephrine responses to hypoglycemia occurs in youth with less than 1 yr duration of type 1 diabetes mellitus. Pediatr Diabetes 15:127-34
Barnea-Goraly, Naama; Raman, Mira; Mazaika, Paul et al. (2014) Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care 37:332-40
Sherr, Jennifer; Tsalikian, Eva; Fox, Larry et al. (2014) Evolution of abnormal plasma glucagon responses to mixed-meal feedings in youth with type 1 diabetes during the first 2 years after diagnosis. Diabetes Care 37:1741-4

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