Journal article

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

David M Maahs, Bruce A Buckingham, Jessica R Castle, Ali Cinar, Edward R Damiano, Eyal Dassau, J Hans DeVries, Francis J Doyle, Steven C Griffen, Ahmad Haidar, Lutz Heinemann, Roman Hovorka, Timothy W Jones, Craig Kollman, Boris Kovatchev, Brian L Levy, Revital Nimri, David N O'Neal, Moshe Philip, Eric Renard Show all



Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study grou..

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Funding Acknowledgements

D.M.M. reports personal fees from Abbott and Insulet and research support from Medtronic, Dexcom, and Roche Diagnostics. B.A.B. reports grant support from JDRF, Medtronic, and Dexcom; personal fees from Medtronic, Sanofi, Tandem Diabetes Care, and Novo Nordisk; and other support from Roche Diagnostics, Dexcom, and Abbott. J.R.C. has a significant financial interest in Pacific Diabetes Technologies, Inc., a company that may have a commercial interest in the results of this research and technology. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University. A.C. reports personal fees from Medtronic and a patent "Automatic insulin pumps using recursive multivariable models and adaptive control algorithms" (#US8690820) issued. E.R.D. reports a patent "Fully automated control system for type 1 diabetes" (#US7806854) issued, grants from JDRF and the National Institutes of Health (NIH), and personal fees from Automated Glucose Control LLC and Animas Corp. J.H.D. reports grants from Medtronic and personal fees from Johnson & Johnson and Sanofi. F.J.D. reports grants from JDRF and NIH and personal fees from Automated Glucose Control LLC and Animas Corp. A.H. owns intellectual property in the field of artificial pancreas (dosing algorithm). A.H. has received consultant and speaker honoraria from SNELL Medical Communication and the Diabetic Children's Foundation and research support from Medtronic. R.H. reports personal fees from Medtronic, Eli Lilly, Novo Nordisk, B. Braun, Sanofi, and Profil and grants from JDRF and Diabetes UK. In addition, R.H. has a patent "Substance monitoring and control in human R.H. reports personal fees from Medtronic, Eli Lilly, Novo Nordisk, B. Braun, Sanofi-Aventis, and Profil, as well as grants from JDRF, Diabetes UK, the National Institute of Diabetes and Digestive and Kidney Diseases, European Commission 7th Framework Programme for Research and Technological Development, and National Institute for Health Research Efficacy and Mechanism Evaluation Programme. In addition, R.H. has a patent "Substance monitoring and control in human or animal bodies" (#US9089305) license, a patent "Overnight closed-loop insulin delivery with model predictive control and glucose measurement error model" (#US8585637) issued, a patent "A system for insulin delivery using glucose regulation and measurement error models" (#US8062249) issued, and a patent "Substance monitoring and control in human or animal bodies" (#US8977504) licensed. T.W.J. reports personal fees and nonfinancial support from Medtronic and personal fees from Novo Nordisk and Animas Corp. B.K. reports grants from Becton, Dickson, and Co. and Sanofi, personal fees from Sanofi, and nonfinancial support from Animas Corp., Roche Diagnostics, and Tandem Diabetes Care. In addition, B.K. has a patent "CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction of insulin delivery" (#US8562587), with royalties paid to Animas Corp.; a patent "Method and apparatus for modular power management and protection of critical services in ambulatory medical devices" (PCT/US12/43883), licensed to TypeZero Technologies; and a patent "Unified platform for monitoring and control of blood glucose levels in diabetic patients" (PCT/US12/43910), licensed to TypeZero Technologies. R.H. is a shareholder in TypeZero Technologies. B.L.L. reports other support from LifeScan and Animas Corp. R.N. reports grants from JDRF and other support from Novo Nordisk and DreaMed Diabetes Ltd. D.N.O.reports grants and personal fees from Medtronic, Roche Diagnostics, Sanofi, and Novo Nordisk. M.P. report grants from Medtronic, Novo Nordisk, Roche Diagnostics, Eli Lilly, Merck, Andromeda, Sanofi, Bristol-Myers Squibb, Kamada, Pfizer, AstraZeneca, NG Solutions Ltd., and Nutriteen Professionals Ltd.; personal fees from Medtronic, Novo Nordisk, Eli Lilly, Sanofi, and Pfizer; and other support from Medtronic, Novo Nordisk, Roche Diagnostics, CGM3 Ltd., NG Solutions Ltd., DreaMed Diabetes Ltd., and Nutriteen Professionals Ltd. M.P. has a patent "Method and system for automatic monitoring of diabetes related treatments" (#US20120123234 A1) pending. E.R. reports personal fees from A. Menarini Diagnostics, Cellnovo, Eli Lilly, Johnson & Johnson, Animas Corp., LifeScan, Medtronic, Novo Nordisk, Abbott, Roche Diagnostics, Dexcom, and Sanofi and nonfinancial support from Abbott, Roche Diagnostics, Dexcom, and Insulet. S.J.R. reports personal fees from Dexcom, Tandem Diabetes Care, Sanofi, Eli Lilly, and Novo Nordisk; nonfinancial support from Eli Lilly, SweetSpot Diabetes, International Biomedical, Abbott, Insulet, and Medtronic; and other support from Companion Medical. S.J.R. has patents pending on aspects of bionic pancreas. S.A.W. reports grants from Medtronic and personal fees from Medtronic, Insulet, and Tandem Diabetes Care. H.Z. reports grants from NIH and JDRF. No other potential conflicts of interest relevant to this article were reported.