Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report
Identifieur interne : 000657 ( Pmc/Curation ); précédent : 000656; suivant : 000658Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report
Auteurs : David M. Maahs [États-Unis] ; Bruce A. Buckingham [États-Unis] ; Jessica R. Castle [États-Unis] ; Ali Cinar [États-Unis] ; Edward R. Damiano [États-Unis] ; Eyal Dassau [États-Unis] ; J. Hans Devries [Pays-Bas] ; Francis J. Doyle [États-Unis] ; Steven C. Griffen [États-Unis] ; Ahmad Haidar [Canada] ; Lutz Heinemann [Allemagne] ; Roman Hovorka [Royaume-Uni] ; Timothy W. Jones [Australie] ; Craig Kollman [États-Unis] ; Boris Kovatchev [États-Unis] ; Brian L. Levy [États-Unis] ; Revital Nimri [Israël] ; David N. O Eal [Australie] ; Moshe Philip [Israël] ; Eric Renard [France] ; Steven J. Russell [États-Unis] ; Stuart A. Weinzimer [États-Unis] ; Howard Zisser [États-Unis] ; John W. Lum [États-Unis]Source :
- Diabetes Care [ 0149-5992 ] ; 2016.
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
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DOI: 10.2337/dc15-2716
PubMed: 27330126
PubMed Central: 4915553
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O Eal</name><affiliation wicri:level="1"><nlm:aff id="aff19">Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria</wicri:regionArea></affiliation></author><author><name sortKey="Philip, Moshe" sort="Philip, Moshe" uniqKey="Philip M" first="Moshe" last="Philip">Moshe Philip</name><affiliation wicri:level="1"><nlm:aff id="aff18">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</nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea>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</wicri:regionArea></affiliation></author><author><name sortKey="Renard, Eric" sort="Renard, Eric" uniqKey="Renard E" first="Eric" last="Renard">Eric Renard</name><affiliation wicri:level="1"><nlm:aff id="aff20">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</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>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</wicri:regionArea></affiliation></author><author><name sortKey="Russell, Steven J" sort="Russell, Steven J" uniqKey="Russell S" first="Steven J." last="Russell">Steven J. Russell</name><affiliation wicri:level="2"><nlm:aff id="aff5">Department of Biomedical Engineering, Boston University, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Department of Biomedical Engineering, Boston University, Boston</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:aff id="aff21">Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Weinzimer, Stuart A" sort="Weinzimer, Stuart A" uniqKey="Weinzimer S" first="Stuart A." last="Weinzimer">Stuart A. 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Maahs</name><affiliation wicri:level="2"><nlm:aff id="aff1">Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Colorado</region></placeName><wicri:cityArea>Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora</wicri:cityArea></affiliation></author><author><name sortKey="Buckingham, Bruce A" sort="Buckingham, Bruce A" uniqKey="Buckingham B" first="Bruce A." last="Buckingham">Bruce A. Buckingham</name><affiliation wicri:level="2"><nlm:aff id="aff2">Division of Pediatric Endocrinology and Diabetes, Department of Pediatric Endocrinology, Stanford University, Stanford, CA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Division of Pediatric Endocrinology and Diabetes, Department of Pediatric Endocrinology, Stanford University, Stanford</wicri:cityArea></affiliation></author><author><name sortKey="Castle, Jessica R" sort="Castle, Jessica R" uniqKey="Castle J" first="Jessica R." last="Castle">Jessica R. Castle</name><affiliation wicri:level="2"><nlm:aff id="aff3">Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oregon</region></placeName><wicri:cityArea>Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland</wicri:cityArea></affiliation></author><author><name sortKey="Cinar, Ali" sort="Cinar, Ali" uniqKey="Cinar A" first="Ali" last="Cinar">Ali Cinar</name><affiliation wicri:level="2"><nlm:aff id="aff4">Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago, IL</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Damiano, Edward R" sort="Damiano, Edward R" uniqKey="Damiano E" first="Edward R." last="Damiano">Edward R. Damiano</name><affiliation wicri:level="2"><nlm:aff id="aff5">Department of Biomedical Engineering, Boston University, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Department of Biomedical Engineering, Boston University, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Dassau, Eyal" sort="Dassau, Eyal" uniqKey="Dassau E" first="Eyal" last="Dassau">Eyal Dassau</name><affiliation wicri:level="2"><nlm:aff id="aff6">Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:aff id="aff7">Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Devries, J Hans" sort="Devries, J Hans" uniqKey="Devries J" first="J. Hans" last="Devries">J. Hans Devries</name><affiliation wicri:level="1"><nlm:aff id="aff8">Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands</nlm:aff><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Doyle, Francis J" sort="Doyle, Francis J" uniqKey="Doyle F" first="Francis J." last="Doyle">Francis J. Doyle</name><affiliation wicri:level="2"><nlm:aff id="aff6">Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:aff id="aff7">Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Griffen, Steven C" sort="Griffen, Steven C" uniqKey="Griffen S" first="Steven C." last="Griffen">Steven C. Griffen</name><affiliation wicri:level="2"><nlm:aff id="aff9">JDRF, New York, NY</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>JDRF, New York</wicri:cityArea></affiliation></author><author><name sortKey="Haidar, Ahmad" sort="Haidar, Ahmad" uniqKey="Haidar A" first="Ahmad" last="Haidar">Ahmad Haidar</name><affiliation wicri:level="1"><nlm:aff id="aff10">Biomedical Engineering Department, McGill University, Montreal, Quebec, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Biomedical Engineering Department, McGill University, Montreal, Quebec</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff11">Division of Endocrinology, McGill University, Montreal, Quebec, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Endocrinology, McGill University, Montreal, Quebec</wicri:regionArea></affiliation></author><author><name sortKey="Heinemann, Lutz" sort="Heinemann, Lutz" uniqKey="Heinemann L" first="Lutz" last="Heinemann">Lutz Heinemann</name><affiliation wicri:level="1"><nlm:aff id="aff12">Profil Institute for Metabolic Research, Neuss, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Profil Institute for Metabolic Research, Neuss</wicri:regionArea></affiliation></author><author><name sortKey="Hovorka, Roman" sort="Hovorka, Roman" uniqKey="Hovorka R" first="Roman" last="Hovorka">Roman Hovorka</name><affiliation wicri:level="1"><nlm:aff id="aff13">Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge</wicri:regionArea></affiliation></author><author><name sortKey="Jones, Timothy W" sort="Jones, Timothy W" uniqKey="Jones T" first="Timothy W." last="Jones">Timothy W. Jones</name><affiliation wicri:level="1"><nlm:aff id="aff14">Telethon Kids Institute, The University of Western Australia, Perth, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Telethon Kids Institute, The University of Western Australia, Perth</wicri:regionArea></affiliation></author><author><name sortKey="Kollman, Craig" sort="Kollman, Craig" uniqKey="Kollman C" first="Craig" last="Kollman">Craig Kollman</name><affiliation wicri:level="2"><nlm:aff id="aff15">Jaeb Center for Health Research, Tampa, FL</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Jaeb Center for Health Research, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="Kovatchev, Boris" sort="Kovatchev, Boris" uniqKey="Kovatchev B" first="Boris" last="Kovatchev">Boris Kovatchev</name><affiliation wicri:level="2"><nlm:aff id="aff16">University of Virginia, Charlottesville, VA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>University of Virginia, Charlottesville</wicri:cityArea></affiliation></author><author><name sortKey="Levy, Brian L" sort="Levy, Brian L" uniqKey="Levy B" first="Brian L." last="Levy">Brian L. Levy</name><affiliation wicri:level="2"><nlm:aff id="aff17">Johnson & Johnson Diabetes Care Companies, Wayne, PA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>Johnson & Johnson Diabetes Care Companies, Wayne</wicri:cityArea></affiliation></author><author><name sortKey="Nimri, Revital" sort="Nimri, Revital" uniqKey="Nimri R" first="Revital" last="Nimri">Revital Nimri</name><affiliation wicri:level="1"><nlm:aff id="aff18">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</nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea>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</wicri:regionArea></affiliation></author><author><name sortKey="O Eal, David N" sort="O Eal, David N" uniqKey="O Eal D" first="David N." last="O Eal">David N. O Eal</name><affiliation wicri:level="1"><nlm:aff id="aff19">Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria</wicri:regionArea></affiliation></author><author><name sortKey="Philip, Moshe" sort="Philip, Moshe" uniqKey="Philip M" first="Moshe" last="Philip">Moshe Philip</name><affiliation wicri:level="1"><nlm:aff id="aff18">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</nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea>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</wicri:regionArea></affiliation></author><author><name sortKey="Renard, Eric" sort="Renard, Eric" uniqKey="Renard E" first="Eric" last="Renard">Eric Renard</name><affiliation wicri:level="1"><nlm:aff id="aff20">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</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>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</wicri:regionArea></affiliation></author><author><name sortKey="Russell, Steven J" sort="Russell, Steven J" uniqKey="Russell S" first="Steven J." last="Russell">Steven J. Russell</name><affiliation wicri:level="2"><nlm:aff id="aff5">Department of Biomedical Engineering, Boston University, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Department of Biomedical Engineering, Boston University, Boston</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:aff id="aff21">Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Weinzimer, Stuart A" sort="Weinzimer, Stuart A" uniqKey="Weinzimer S" first="Stuart A." last="Weinzimer">Stuart A. Weinzimer</name><affiliation wicri:level="2"><nlm:aff id="aff22">Yale University School of Medicine, New Haven, CT</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Yale University School of Medicine, New Haven</wicri:cityArea></affiliation></author><author><name sortKey="Zisser, Howard" sort="Zisser, Howard" uniqKey="Zisser H" first="Howard" last="Zisser">Howard Zisser</name><affiliation wicri:level="2"><nlm:aff id="aff6">Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara</wicri:cityArea></affiliation></author><author><name sortKey="Lum, John W" sort="Lum, John W" uniqKey="Lum J" first="John W." last="Lum">John W. Lum</name><affiliation wicri:level="2"><nlm:aff id="aff15">Jaeb Center for Health Research, Tampa, FL</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Jaeb Center for Health Research, Tampa</wicri:cityArea></affiliation></author></analytic><series><title level="j">Diabetes Care</title><idno type="ISSN">0149-5992</idno><idno type="eISSN">1935-5548</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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 <italic>1</italic>) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA<sub>1c</sub>, and <italic>2</italic>) 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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bergenstal, Rm" uniqKey="Bergenstal R">RM Bergenstal</name></author><author><name sortKey="Tamborlane, Wv" uniqKey="Tamborlane W">WV Tamborlane</name></author><author><name sortKey="Ahmann, A" uniqKey="Ahmann A">A Ahmann</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hermanides, J" uniqKey="Hermanides J">J Hermanides</name></author><author><name sortKey="N Rgaard, K" uniqKey="N Rgaard K">K Nørgaard</name></author><author><name sortKey="Bruttomesso, D" uniqKey="Bruttomesso D">D 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Diabetes Care</journal-id><journal-id journal-id-type="iso-abbrev">Diabetes Care</journal-id><journal-id journal-id-type="hwp">diacare</journal-id><journal-id journal-id-type="pmc">dcare</journal-id><journal-id journal-id-type="publisher-id">Diabetes Care</journal-id><journal-title-group><journal-title>Diabetes Care</journal-title></journal-title-group><issn pub-type="ppub">0149-5992</issn><issn pub-type="epub">1935-5548</issn><publisher><publisher-name>American Diabetes Association</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27330126</article-id><article-id pub-id-type="pmc">4915553</article-id><article-id pub-id-type="publisher-id">2716</article-id><article-id pub-id-type="doi">10.2337/dc15-2716</article-id><article-categories><subj-group subj-group-type="heading"><subject>The Artificial Pancreas in 2016: A Digital Treatment Ecosystem for Diabetes</subject></subj-group></article-categories><title-group><article-title>Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Maahs</surname><given-names>David M.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Buckingham</surname><given-names>Bruce A.</given-names></name><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Castle</surname><given-names>Jessica R.</given-names></name><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Cinar</surname><given-names>Ali</given-names></name><xref ref-type="aff" rid="aff4"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Damiano</surname><given-names>Edward R.</given-names></name><xref ref-type="aff" rid="aff5"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Dassau</surname><given-names>Eyal</given-names></name><xref ref-type="aff" rid="aff6"><sup>6</sup></xref><xref ref-type="aff" rid="aff7"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>DeVries</surname><given-names>J. Hans</given-names></name><xref ref-type="aff" rid="aff8"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Doyle</surname><given-names>Francis J.</given-names><suffix>III</suffix></name><xref ref-type="aff" rid="aff6"><sup>6</sup></xref><xref ref-type="aff" rid="aff7"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Griffen</surname><given-names>Steven C.</given-names></name><xref ref-type="aff" rid="aff9"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Haidar</surname><given-names>Ahmad</given-names></name><xref ref-type="aff" rid="aff10"><sup>10</sup></xref><xref ref-type="aff" rid="aff11"><sup>11</sup></xref></contrib><contrib contrib-type="author"><name><surname>Heinemann</surname><given-names>Lutz</given-names></name><xref ref-type="aff" rid="aff12"><sup>12</sup></xref></contrib><contrib contrib-type="author"><name><surname>Hovorka</surname><given-names>Roman</given-names></name><xref ref-type="aff" rid="aff13"><sup>13</sup></xref></contrib><contrib contrib-type="author"><name><surname>Jones</surname><given-names>Timothy W.</given-names></name><xref ref-type="aff" rid="aff14"><sup>14</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kollman</surname><given-names>Craig</given-names></name><xref ref-type="aff" rid="aff15"><sup>15</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kovatchev</surname><given-names>Boris</given-names></name><xref ref-type="aff" rid="aff16"><sup>16</sup></xref></contrib><contrib contrib-type="author"><name><surname>Levy</surname><given-names>Brian L.</given-names></name><xref ref-type="aff" rid="aff17"><sup>17</sup></xref></contrib><contrib contrib-type="author"><name><surname>Nimri</surname><given-names>Revital</given-names></name><xref ref-type="aff" rid="aff18"><sup>18</sup></xref></contrib><contrib contrib-type="author"><name><surname>O’Neal</surname><given-names>David N.</given-names></name><xref ref-type="aff" rid="aff19"><sup>19</sup></xref></contrib><contrib contrib-type="author"><name><surname>Philip</surname><given-names>Moshe</given-names></name><xref ref-type="aff" rid="aff18"><sup>18</sup></xref></contrib><contrib contrib-type="author"><name><surname>Renard</surname><given-names>Eric</given-names></name><xref ref-type="aff" rid="aff20"><sup>20</sup></xref></contrib><contrib contrib-type="author"><name><surname>Russell</surname><given-names>Steven J.</given-names></name><xref ref-type="aff" rid="aff5"><sup>5</sup></xref><xref ref-type="aff" rid="aff21"><sup>21</sup></xref></contrib><contrib contrib-type="author"><name><surname>Weinzimer</surname><given-names>Stuart A.</given-names></name><xref ref-type="aff" rid="aff22"><sup>22</sup></xref></contrib><contrib contrib-type="author"><name><surname>Zisser</surname><given-names>Howard</given-names></name><xref ref-type="aff" rid="aff6"><sup>6</sup></xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Lum</surname><given-names>John W.</given-names></name><xref ref-type="aff" rid="aff15"><sup>15</sup></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><aff id="aff1"><sup>1</sup>Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO</aff><aff id="aff2"><sup>2</sup>Division of Pediatric Endocrinology and Diabetes, Department of Pediatric Endocrinology, Stanford University, Stanford, CA</aff><aff id="aff3"><sup>3</sup>Department of Medicine, Division of Endocrinology, Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR</aff><aff id="aff4"><sup>4</sup>Department of Chemical and Biological Engineering, Illinois Institute of Technology, Chicago, IL</aff><aff id="aff5"><sup>5</sup>Department of Biomedical Engineering, Boston University, Boston, MA</aff><aff id="aff6"><sup>6</sup>Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara, CA</aff><aff id="aff7"><sup>7</sup>Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA</aff><aff id="aff8"><sup>8</sup>Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands</aff><aff id="aff9"><sup>9</sup>JDRF, New York, NY</aff><aff id="aff10"><sup>10</sup>Biomedical Engineering Department, McGill University, Montreal, Quebec, Canada</aff><aff id="aff11"><sup>11</sup>Division of Endocrinology, McGill University, Montreal, Quebec, Canada</aff><aff id="aff12"><sup>12</sup>Profil Institute for Metabolic Research, Neuss, Germany</aff><aff id="aff13"><sup>13</sup>Wellcome Trust-Medical Research Clinical Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.</aff><aff id="aff14"><sup>14</sup>Telethon Kids Institute, The University of Western Australia, Perth, Australia</aff><aff id="aff15"><sup>15</sup>Jaeb Center for Health Research, Tampa, FL</aff><aff id="aff16"><sup>16</sup>University of Virginia, Charlottesville, VA</aff><aff id="aff17"><sup>17</sup>Johnson & Johnson Diabetes Care Companies, Wayne, PA</aff><aff id="aff18"><sup>18</sup>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</aff><aff id="aff19"><sup>19</sup>Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia</aff><aff id="aff20"><sup>20</sup>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</aff><aff id="aff21"><sup>21</sup>Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA</aff><aff id="aff22"><sup>22</sup>Yale University School of Medicine, New Haven, CT</aff></contrib-group><author-notes><corresp id="cor1">Corresponding author: John W. Lum, <email>jlum@jaeb.org</email>.</corresp></author-notes><pub-date pub-type="ppub"><month>7</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>20</day><month>3</month><year>2016</year></pub-date><volume>39</volume><issue>7</issue><fpage>1175</fpage><lpage>1179</lpage><permissions><copyright-statement>© 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.</copyright-statement><copyright-year>2016</copyright-year></permissions><self-uri xlink:title="pdf" xlink:href="dc152716.pdf"></self-uri><abstract><p>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 <italic>1</italic>) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA<sub>1c</sub>, and <italic>2</italic>) 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.</p></abstract><counts><page-count count="5"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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