Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

David M Maahs¹, Bruce A Buckingham², Jessica R Castle³, Ali Cinar⁴, Edward R Damiano⁵, Eyal Dassau⁶, J Hans DeVries⁷, Francis J Doyle 3rd⁶, Steven C Griffen⁸, Ahmad Haidar⁹, Lutz Heinemann¹⁰, Roman Hovorka¹¹, Timothy W Jones¹², Craig Kollman¹³, Boris Kovatchev¹⁴, Brian L Levy¹⁵, Revital Nimri¹⁶, David N O'Neal¹⁷, Moshe Philip¹⁶, Eric Renard¹⁸, Steven J Russell¹⁹, Stuart A Weinzimer²⁰, Howard Zisser²¹, John W Lum²²

Affiliations

¹ Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
² Division of Pediatric Endocrinology and Diabetes, Department of Pediatric Endocrinology, Stanford University, Stanford, CA.
³ Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
⁴ Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago, IL.
⁵ Department of Biomedical Engineering, Boston University, Boston, MA.
⁶ Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
⁷ Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
⁸ JDRF, New York, NY.
⁹ Biomedical Engineering Department, McGill University, Montreal, Quebec, Canada Division of Endocrinology, McGill University, Montreal, Quebec, Canada.
¹⁰ Profil Institute for Metabolic Research, Neuss, Germany.
¹¹ Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
¹² Telethon Kids Institute, The University of Western Australia, Perth, Australia.
¹³ Jaeb Center for Health Research, Tampa, FL.
¹⁴ University of Virginia, Charlottesville, VA.
¹⁵ Johnson & Johnson Diabetes Care Companies, Wayne, PA.
¹⁶ Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
¹⁷ Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
¹⁸ Department of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Centre 1411, Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France.
¹⁹ Department of Biomedical Engineering, Boston University, Boston, MA Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
²⁰ Yale University School of Medicine, New Haven, CT.
²¹ Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA.
²² Jaeb Center for Health Research, Tampa, FL jlum@jaeb.org.

PMID: 27330126
PMCID: PMC4915553
DOI: 10.2337/dc15-2716

Review

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

David M Maahs et al. Diabetes Care. 2016 Jul.

. 2016 Jul;39(7):1175-9.

doi: 10.2337/dc15-2716.

Authors

Affiliations

¹ Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
² Division of Pediatric Endocrinology and Diabetes, Department of Pediatric Endocrinology, Stanford University, Stanford, CA.
³ Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
⁴ Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago, IL.
⁵ Department of Biomedical Engineering, Boston University, Boston, MA.
⁶ Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
⁷ Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
⁸ JDRF, New York, NY.
⁹ Biomedical Engineering Department, McGill University, Montreal, Quebec, Canada Division of Endocrinology, McGill University, Montreal, Quebec, Canada.
¹⁰ Profil Institute for Metabolic Research, Neuss, Germany.
¹¹ Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
¹² Telethon Kids Institute, The University of Western Australia, Perth, Australia.
¹³ Jaeb Center for Health Research, Tampa, FL.
¹⁴ University of Virginia, Charlottesville, VA.
¹⁵ Johnson & Johnson Diabetes Care Companies, Wayne, PA.
¹⁶ Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
¹⁷ Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
¹⁸ Department of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Centre 1411, Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France.
¹⁹ Department of Biomedical Engineering, Boston University, Boston, MA Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
²⁰ Yale University School of Medicine, New Haven, CT.
²¹ Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA.
²² Jaeb Center for Health Research, Tampa, FL jlum@jaeb.org.

PMID: 27330126
PMCID: PMC4915553
DOI: 10.2337/dc15-2716

Abstract

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 groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.

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References

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Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

Affiliations

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical