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Lauren M. Huyett, Eyal Dassau, and Francis J. Doyle III Department of Chemical Engineering University of California Santa Barbara Santa Barbara, CA 93106.

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Presentation on theme: "Lauren M. Huyett, Eyal Dassau, and Francis J. Doyle III Department of Chemical Engineering University of California Santa Barbara Santa Barbara, CA 93106."— Presentation transcript:

1 Lauren M. Huyett, Eyal Dassau, and Francis J. Doyle III Department of Chemical Engineering University of California Santa Barbara Santa Barbara, CA 93106 huyett@umail.ucsb.edu TRENDS IN THE CLINICAL DEVELOPMENT OF AN ARTIFICIAL PANCREAS: GUIDANCE FOR THE FUTURE ATTD 2015 Paris, France 20 February 2015

2 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Clinical Evaluation of the Artificial Pancreas 20/2/15 2 74 clinical studies have been published to date What patterns have emerged? What can we learn from cataloguing and analyzing these studies?

3 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Development of the Clinical Trial Database

4 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Development of the Clinical Trial Database Branch 1 Branch 2 Branch 3 Studies/Protocol Branches

5 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Website Interface to Query Database 20/2/15 5 www.thedoylegroup.org/apdatabase

6 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Website Interface to Query Database 20/2/15 6 www.thedoylegroup.org/apdatabase

7 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Website Interface to Query Database 20/2/15 7 www.thedoylegroup.org/apdatabase

8 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Website Interface to Query Database 20/2/15 8 www.thedoylegroup.org/apdatabase

9 Lauren M. Huyettwww.thedoylegroup.org/apdatabase

10 Website Interface to Query Database 20/2/15 10 www.thedoylegroup.org/apdatabase

11 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Website Interface to Query Database 20/2/15 11 www.thedoylegroup.org/apdatabase III

12 Lauren M. Huyettwww.thedoylegroup.org/apdatabase What are the Study Objectives? 20/2/15 12 Word cloud generated from self-described trial objectives from 2004-2015

13 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Common Themes in Trial Objectives 20/2/15 13 ThemeCount overnight29 meal23 safety19 efficacy17 feasibility11 hypoglycemia8 MPC7 exercise6 bihormonal5 children5 glucagon5 home4 adolescents4 MD-Logic4 breakfast4 free-living3

14 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Trends in Trial Protocol At least 1 meal with: Only one study so far has incorporated unannounced meals in an outpatient setting.

15 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Reported Mean Subject Age 54 studies reported mean age with standard deviation Studies Ranked by Mean Age

16 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Overall Trial Results 20/2/15 16 From Doyle, et. al, Diabetes, 2014 Studies from 2010-2013 Red Shading: Results calculated for >12h of closed-loop

17 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Overall Trial Results 20/2/15 17 From Doyle, et. al, Diabetes, 2014 Studies from 2010-2013 Additional Studies 2014-2015 Red Shading: Results calculated for >12h of closed-loop

18 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Overall Trial Results For studies 2010 – 2015 reporting % Time 70-180 mg/dL Meal size is another important factor but is not reported in a standardized fashion.

19 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Regression Analysis of Time in Range Results 20/2/15 19 PredictorsOptions Meal ProtocolNone, Announced, Unannounced ControllerMPC, PID/PI/PD, Fuzzy Logic, Empirical ExerciseYes or No GlucagonYes or No Year2011-2015 Response Variable: Percentage of time in range from 70±2 mg/dL to 180 mg/dL Results reported for 62/88 protocols in database What protocol or design factors are most influential to percent time in range?

20 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Regression Analysis of Time in Range Results 20/2/15 20 PredictorsOptions Meal ProtocolNone, Announced, Unannounced ControllerMPC, PID/PI/PD, Fuzzy Logic, Empirical ExerciseYes or No GlucagonYes or No Year2011-2015 Meal Protocol None00 Announced01 Unannounced10 Controller MPC000 PID/PI/PD100 Fuzzy Logic010 Empirical001 Dummy Variable Schemes What protocol or design factors are most influential to percent time in range? Response Variable: Percentage of time in range from 70±2 mg/dL to 180 mg/dL Results reported for 62/88 protocols in database

21 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Regression Results 20/2/15 21 VariableMeaningEstimateSEt Statp Value InterceptAll variables 0876.0144.7E-20 Unannounced Meal-285.4-5.32.6E-06 Announced Meal-144.9-2.90.0057 PI/PID/PD9.66.21.60.12 Fuzzy Logic0.58.60.060.95 Empirical-2.45.1-0.470.64 Exercise6.74.31.60.13 Glucagon-0.485.5-0.0880.93 Year-2012-2.52.3-1.10.30 No Meals BolusNo Bolus Protocol Expected % Time 70- 180 mg/dL No Meals84 Announced Meal72 Unannounced Meal62 Metric to compare new results

22 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Conclusions 20/2/15 22 74 clinical studies of the AP have been published since 2004 Searchable database is available for public use at www.thedoylegroup.org/apdatabase www.thedoylegroup.org/apdatabase Multiple linear regression shows that meal compensation strategy is the biggest predictor of percent time in range Many other factors can also affect trial outcome Starting conditions Controller tuning or model used Technological difficulties Meal size and timing Future trial results may be compared to expected values from model to gauge improvement

23 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Acknowledgements 20/2/15 23 Research Group Dr. Ravi Gondhalekar Dr. Isuru Dasanayake Dr. Eyal Dassau Dr. Alejandro Laguna Sanz Joon-Bok Lee NIH Grant DP3DK101068

24 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Type of Controller 20/2/15 24

25 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Meal/Exercise Details 20/2/15 25 Idea: have a bar graph and then also have the scatter plot of percent time in range versus range or percent time in range versus length of closed-loop

26 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Inclusion/Exclusion Criteria 20/2/15 26

27 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Number of Subjects 20/2/15 27 Also age and gender representation

28 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Hypoglycemia Info 20/2/15 28

29 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Inpatient/Outpatient/ In Between 20/2/15 29 Also length of closed-loop

30 Lauren M. Huyettwww.thedoylegroup.org/apdatabase Closed-Loop Results 20/2/15 30 Update on Diabetes Care figure

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