Florida Network Symposium

Transcription

1 Katrina J. Ruedy, MSPH John W. Lum, MS Jaeb Center for Health Research NE Florida Network Symposium In Conjunction with The 28th Annual Clinical Conference on Diabetes

2 Jaeb Center for Health Research (JCHR) Overview

3 JCHR History Started by Roy Beck in 1993 as a freestanding nonprofit company Moved clinical trials coordinating center from University of South Florida Primarily serves as a coordinating center for multi-center clinical trials in eye diseases and type 1 diabetes

4 Current JCHR Staff Ø 8 project directors Ø 17 statisticians/epidemiologists Ø 33 IT staff (operations, database, programming) Ø 13 protocol monitors Ø 9 project administrative staff Ø 10 research assistants Ø 8 central administrative staff

5 Jaeb Center for Health Research Diabetes Projects 2001-Present 2001: Diabetes Research in Children Network (NIH) 2002: Diabetic Retinopathy Clinical Research Network (NIH) 2006: JDRF CGM Randomized Clinical Trial (JDRF) 2007: Artificial Pancreas Project (JDRF and NIDDK) 2008: Pediatric Diabetes Consortium (NovoNordisk) 2010: T1D Exchange (Helmsley Trust) 2012: CONCEPTT Pregnancy Trial (JDRF)

6 CGM Data Management Ø CGM in Diabetic Gastroparesis (NIH-Johns Hopkins) Ø Optimizing CGM in Youth with T1D (NIH-Joslin)

7 Clinical Centers University of Colorado: Denver, CO (D1 only) Children s Hospital of Iowa: Iowa City, IA Nemours Children s Clinic: Jacksonville, FL Stanford University: Stanford, CA Yale University: New Haven, CT Washington University: St. Louis, MO (D2 only) Coordinating Center Jaeb Center for Health Research: Tampa, FL Central Laboratory University of Minnesota Central Laboratory: Minneapolis, MN

8 Objectives of DirecNet To investigate the use of technological advances in the management of type 1 diabetes in children and adolescents To develop a better understanding of hypoglycemia, its implications, risk factors and prevention

9 DirecNet Protocols Completed 8 observational studies 2 randomized clinical trials 1 cross-sectional study Ongoing 1 randomized clinical trial 1 cross-sectional study

10 The Diabetic Retinopathy Clinical Research Network Dedicated to multicenter clinical research of diabetic retinopathy, macular edema and associated conditions Supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services EY14231, EY018817

11 Objective * The development of a collaborative network to facilitate multicenter clinical research on diabetic retinopathy, DME and associated conditions.

12 DRCR.net Organization * Overall Network Participation (as of 9/30/12) * 266 sites submitted application for Network * 950 total Investigators; 3018 additional personnel * Network is open and continually solicits participation of new sites and investigators

13 DRCR.net Protocols Completed 6 observational studies 6 randomized clinical trials 3 cross-sectional study Ongoing 5 randomized clinical trial 1 cross-sectional study

14 Pediatric Diabetes Consortium Funded by unrestricted grant from Novo Nordisk Inc. PDC I: December August 2011 PDC II: September August 2013

15 Pediatric Diabetes Consortium Coordinating Center Jaeb Center for Health Research, Tampa, FL Clinical Centers Barbara Davis Center Baylor School of Medicine Children s Hospital Los Angeles Stanford University University of Florida University of Michigan Yale University Children s Hospital of Philadelphia (T2D Only)

16 Objectives T1D NeOn Registry (1,052 Participants) To improve the care of children with type 1 diabetes through sharing best practices, collecting outcome data in a common data repository and collectively advocating for changes in care focused on evidence T2D Registry (380 Participants; recruitment ongoing) To develop and use a common data repository to assess treatment approaches for adolescents with type 2 diabetes including new treatment approaches

17 T1D Exchange Clinic Registry A Helmsley Charitable Trust Initiative

18 Clinical Centers N = 67 Types of Patients Setting Institution Adult Pediatric Community Both Managed Care

19 Clinic Registry Objectives Collect clinical and laboratory data on a large number of patients with type 1 diabetes to: * Address pertinent clinical issues * Conduct exploratory/hypothesis-generating analyses * Identify patients interested in being contacted about participating in research studies * Categorize patients for future clinical studies and biobank analyses

20 Recruitment ~26, Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12

21 CONCEPTT Pregnancy Trial Continuous Glucose Monitoring in Pregnancy Treatment Trial

22 CONCEPTT Study Group Clinical Centers Toronto, Canada Cambridge, UK Tel Aviv, Israel Santa Barbara, CA Barcelona, Spain Study Coordinating Center Centre for Maternal, Infant, and Child Research Toronto, Canada CGM Coordinating Center Jaeb Center for Health Research Tampa, FL

23 Does the use of RT-CGM in women with type 1 diabetes who are pregnant or planning pregnancy improve glycemic control as measured by HbA1c?

24 Recruitment Pre-pregnant group: 110, HbA1c 7.0% - <10.0% * 8 randomized Pregnant group: 214, HbA1c 6.5% - <10.0% * 2 randomized

25 Artificial Pancreas Project JDRF and NIH Funding ~6 full-time Jaeb Center staff 5 multicenter AP protocols coordinated since 2007 Contributions to ~40 additional AP protocols led by collaborating sites

26 Collaborating Sites 16 sites worldwide running clinical trials, providing engineering resources, or doing both: Dose Safety Oregon W. Ontario Boston Yale Cambridge W. Australia Stanford Rensselaer Harvard UCSB/ Sansum Colorado Virginia Montpellier Pavia/Padova Israel Jaeb Center for Health Research, Tampa, FL ConsorPum CoordinaPng Center

27 Pathway to an ArPficial Pancreas

28 Example ArPficial Pancreas Study PSO1 - Pump Shutoff when hypo predicted Randomized controlled study, summer Clinical sites: Stanford and Colorado N=20 subjects x 21 nights in- home use overnight Safety study with bedside hardware/soeware plagorm (developed by Jaeb Center & Rensselaer) Goal was to test bedside system and demonstrate hypoglycemia avoidance without increased morning hyperglycemia incidence. Next step: larger outpanent study, finishing May 2013

29 Example ArPficial Pancreas Study PSO1: Three Algorithm Versions Tested Safety: increase in morning BG; lower = beyer Difference between Control Nights and IntervenNon Nights Efficacy: hypoglycemia incidence; lower = beyer

30 Study Clinical Sites Key Points Start/End Date PSO3 AcPve/Planned In- Home AP Studies Coordinated by Jaeb Center Stanford, Colorado, Ontario N = 45; Ages 15-45; 42 nights use Overnight; predictive pump suspension Hypoglycemia reduction Nov 2012 May 2013 PSO4 Stanford, Colorado, Ontario N = 90; Ages 3-14; 42 nights use Overnight; predictive pump suspension Hypoglycemia reduction Jun 2013 Mar 2014 APCam08 Cambridge, Leeds, London (UK) N = 24; Age 6-18; three months use Overnight; active insulin dosing Increased time in target glucose range; hypoglycemia reduction Aug 2013 July 2014 CTR Pilot 3 Virginia, UCSB, Stanford, France, Italy N = 48; Age 18-69; two weeks use Day and night; active insulin dosing Hypoglycemia reduction; increased time in target glucose range Sep 2013 Mar 2014