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 transcript:

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

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

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

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

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

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

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

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

Lauren M. Huyettwww.thedoylegroup.org/apdatabase

Website Interface to Query Database 20/2/

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

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

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

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.

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

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

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

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

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 Year 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?

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 Year 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

Lauren M. Huyettwww.thedoylegroup.org/apdatabase Regression Results 20/2/15 21 VariableMeaningEstimateSEt Statp Value InterceptAll variables E-20 Unannounced Meal E-06 Announced Meal PI/PID/PD Fuzzy Logic Empirical Exercise Glucagon Year No Meals BolusNo Bolus Protocol Expected % Time mg/dL No Meals84 Announced Meal72 Unannounced Meal62 Metric to compare new results

Lauren M. Huyettwww.thedoylegroup.org/apdatabase Conclusions 20/2/ clinical studies of the AP have been published since 2004 Searchable database is available for public use at 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

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

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

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

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

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

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

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

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