1. Progress Toward Artificial Pancreas (AP) Systems – A Timeline 9.28.16 1 1970s 1980s 2004 2005 2006 2008 2009 2011 2012 2013 2015 2016 2010 2014 2004: JDRF Yale hypoglycemia grant supports prototype Medtronic AP system March 2006: FDA adds AP to Critical Path list May 2006: Majority of Congress sends letters to HHS Secretary on how agency can advance AP September 2006: JDRF funds CGM Trial and AP Consortium, supporting multiple AP approaches September 2006: Senate holds hearing on need to develop AP March 2006: FDA adds AP to Critical Path list May 2006: Majority of Congress sends letters to HHS Secretary on how agency can advance AP September 2006: JDRF funds CGM Trial and AP Consortium, supporting multiple AP approaches September 2006: Senate holds hearing on need to develop AP May 2009: JDRF partners with Helmsley Charitable Trust to accelerate AP June 2009: JDRF’s Aaron Kowalski publishes six step roadmap for AP research and development 2 September 2009: NIH funds $23 million in AP grants from Special Diabetes Program May 2009: JDRF partners with Helmsley Charitable Trust to accelerate AP June 2009: JDRF’s Aaron Kowalski publishes six step roadmap for AP research and development 2 September 2009: NIH funds $23 million in AP grants from Special Diabetes Program 1 Weinzimer et al. 2008. Diabetes Care 31(5): 934-939 2 Kowalski, Aaron J. Diabetes Technol Ther. 2009 Jun;11 Suppl 1:S113-9 3 Kovatchev et al. 2010. Journal of Diabetes Science and Technology 4(6): 1374-1381 4 Thabit et al. 2015. New England Journal of Medicine 373(22): 2129-2140 March 2011: Based on recommendations from clinical panel, JDRF develops and submits an AP guidance to FDA April/May 2011: Majority of Congress sends letters to FDA urging next steps in AP development November 2011: Senate press conference urging FDA to issue clear and reasonable FDA guidance March 2011: Based on recommendations from clinical panel, JDRF develops and submits an AP guidance to FDA April/May 2011: Majority of Congress sends letters to FDA urging next steps in AP development November 2011: Senate press conference urging FDA to issue clear and reasonable FDA guidance February 2016: Insulet announces AP plans April 2016: BetaBionics launches March 2016: JDRF, Helmsley Charitable Trust & T1D Exchange launch health policy initiative June 2016: Medtronic files for premarket approval for 670G September 2016: FDA approves 670G – the first hybrid closed loop system – for use for in people with diabetes 14 years and above February 2016: Insulet announces AP plans April 2016: BetaBionics launches March 2016: JDRF, Helmsley Charitable Trust & T1D Exchange launch health policy initiative June 2016: Medtronic files for premarket approval for 670G September 2016: FDA approves 670G – the first hybrid closed loop system – for use for in people with diabetes 14 years and above September 2013: FDA approves Medtronic 530G, a first step towards an AP system, which stops insulin delivery when glucose is low 1970s: Biostator, a refrigerator- sized hospital based system released 1983: First insulin pump July 2005: FDA approves first real- time CGM October 2005: JDRF launches Artificial Pancreas Project July 2005: FDA approves first real- time CGM October 2005: JDRF launches Artificial Pancreas Project May 2008: Yale research, funded by JDRF and NIH, shows for the first time a hybrid closed loop approach (a precursor to the 670G) can improve glucose overnight as well as at meal-time vs a fully- automated approach 1 September 2008: JDRF CGM Trial published in New England Journal of Medicine and private plans start to cover them May 2008: Yale research, funded by JDRF and NIH, shows for the first time a hybrid closed loop approach (a precursor to the 670G) can improve glucose overnight as well as at meal-time vs a fully- automated approach 1 September 2008: JDRF CGM Trial published in New England Journal of Medicine and private plans start to cover them January 2010: JDRF partners with Animas to advance AP systems November 2010: The first international, multisite closed loop study is published 3 January 2010: JDRF partners with Animas to advance AP systems November 2010: The first international, multisite closed loop study is published 3 March 2012: FDA approves the first outpatient AP trial, funded by JDRF November 2012: FDA releases final AP guidance based on recommendations from JDRF, providing a clear and reasonable regulatory roadmap March 2012: FDA approves the first outpatient AP trial, funded by JDRF November 2012: FDA releases final AP guidance based on recommendations from JDRF, providing a clear and reasonable regulatory roadmap February 2015: Tandem announces AP project June 2015: TypeZero forms November 2015: Study shows at home use of an AP system improved glucose control and reduced hypoglycemia 4 February 2015: Tandem announces AP project June 2015: TypeZero forms November 2015: Study shows at home use of an AP system improved glucose control and reduced hypoglycemia 4 October 2014: FDA approves DexCom Share November 2014: Smartloop (now Bigfoot) launches October 2014: FDA approves DexCom Share November 2014: Smartloop (now Bigfoot) launches