title: Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.
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.
authors.affiliation: Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.
authors.forename: David M
authors.initials: DM
authors.lastname: Maahs
authors.affiliation: Division of Pediatric Endocrinology and Diabetes, Department of Pediatric Endocrinology, Stanford University, Stanford, CA.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Buckingham
authors.affiliation: Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
authors.forename: Jessica R
authors.initials: JR
authors.lastname: Castle
authors.affiliation: Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago, IL.
authors.forename: Ali
authors.initials: A
authors.lastname: Cinar
authors.affiliation: Department of Biomedical Engineering, Boston University, Boston, MA.
authors.forename: Edward R
authors.initials: ER
authors.lastname: Damiano
authors.affiliation: 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.
authors.forename: Eyal
authors.initials: E
authors.lastname: Dassau
authors.affiliation: Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: J Hans
authors.initials: JH
authors.lastname: DeVries
authors.affiliation: 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.
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Doyle
authors.affiliation: JDRF, New York, NY.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Griffen
authors.affiliation: Biomedical Engineering Department, McGill University, Montreal, Quebec, Canada Division of Endocrinology, McGill University, Montreal, Quebec, Canada.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Haidar
authors.affiliation: Profil Institute for Metabolic Research, Neuss, Germany.
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
authors.affiliation: Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
authors.forename: Roman
authors.initials: R
authors.lastname: Hovorka
authors.affiliation: Telethon Kids Institute, The University of Western Australia, Perth, Australia.
authors.forename: Timothy W
authors.initials: TW
authors.lastname: Jones
authors.affiliation: Jaeb Center for Health Research, Tampa, FL.
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.affiliation: University of Virginia, Charlottesville, VA.
authors.forename: Boris
authors.initials: B
authors.lastname: Kovatchev
authors.affiliation: Johnson & Johnson Diabetes Care Companies, Wayne, PA.
authors.forename: Brian L
authors.initials: BL
authors.lastname: Levy
authors.affiliation: 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.
authors.forename: Revital
authors.initials: R
authors.lastname: Nimri
authors.affiliation: Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
authors.forename: David N
authors.initials: DN
authors.lastname: O'Neal
authors.affiliation: 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.
authors.forename: Moshe
authors.initials: M
authors.lastname: Philip
authors.affiliation: 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.
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.affiliation: Department of Biomedical Engineering, Boston University, Boston, MA Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Russell
authors.affiliation: Yale University School of Medicine, New Haven, CT.
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Weinzimer
authors.affiliation: Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA.
authors.forename: Howard
authors.initials: H
authors.lastname: Zisser
authors.affiliation: Jaeb Center for Health Research, Tampa, FL jlum@jaeb.org.
authors.forename: John W
authors.initials: JW
authors.lastname: Lum
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000628:therapy*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D019397:Pancreas, Artificial
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human