AustralieFrV1, Main, Exploration, bibRecord, 001A00

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

Identifieur interne : 001A00 ( Main/Exploration ); précédent : 001999; suivant : 001A01

Outcome 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.

RBID : PMC:4915553

Descripteurs français

KwdFr :
- Consensus, Diabète de type 1 (), Diabète de type 1 (sang), Essais cliniques comme sujet, Glycémie (métabolisme), Humains, Hémoglobine A glycosylée (analyse), Pancréas artificiel, Évaluation de résultat (soins) ().
MESH :
- analyse : Hémoglobine A glycosylée.
- métabolisme : Glycémie.
- sang : Diabète de type 1.
- Consensus, Diabète de type 1, Essais cliniques comme sujet, Humains, Pancréas artificiel, Évaluation de résultat (soins).

English descriptors

KwdEn :
- Blood Glucose (metabolism), Clinical Trials as Topic, Consensus, Diabetes Mellitus, Type 1 (blood), Diabetes Mellitus, Type 1 (therapy), Hemoglobin A, Glycosylated (analysis), Humans, Outcome Assessment (Health Care) (methods), Pancreas, Artificial.
MESH :
- chemical , analysis : Hemoglobin A, Glycosylated.
- chemical , metabolism : Blood Glucose.
- blood : Diabetes Mellitus, Type 1.
- methods : Outcome Assessment (Health Care).
- therapy : Diabetes Mellitus, Type 1.
- Clinical Trials as Topic, Consensus, Humans, Pancreas, Artificial.

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 HbA_1c, 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.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4915553

DOI: 10.2337/dc15-2716
PubMed: 27330126
PubMed Central: 4915553

Affiliations:

Le document en format XML

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<wicri:cityArea>Department of Chemical Engineering, University of California Santa Barbara, Santa Barbara</wicri:cityArea>
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<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>
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<author><name sortKey="Devries, J Hans" sort="Devries, J Hans" uniqKey="Devries J" first="J. Hans" last="Devries">J. Hans Devries</name>
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<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea>Department of Endocrinology, Academic Medical Centre, University of Amsterdam, Amsterdam</wicri:regionArea>
<placeName><settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
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<author><name sortKey="Doyle, Francis J" sort="Doyle, Francis J" uniqKey="Doyle F" first="Francis J." last="Doyle">Francis J. Doyle</name>
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<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>
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<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>
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</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="4"><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>
<orgName type="university">Université McGill</orgName>
<placeName><settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><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>
<orgName type="university">Université McGill</orgName>
<placeName><settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</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>
<wicri:noRegion>Neuss</wicri:noRegion>
<wicri:noRegion>Neuss</wicri:noRegion>
<wicri:noRegion>Neuss</wicri:noRegion>
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</author>
<author><name sortKey="Hovorka, Roman" sort="Hovorka, Roman" uniqKey="Hovorka R" first="Roman" last="Hovorka">Roman Hovorka</name>
<affiliation wicri:level="4"><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>
<orgName type="university">Université de Cambridge</orgName>
<placeName><settlement type="city">Cambridge</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Angleterre de l'Est</region>
</placeName>
</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>
<wicri:noRegion>Perth</wicri:noRegion>
</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>
<wicri:noRegion>Petah Tikva</wicri:noRegion>
</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="4"><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>
<orgName type="university">Université de Melbourne</orgName>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</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>
<wicri:noRegion>Petah Tikva</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Renard, Eric" sort="Renard, Eric" uniqKey="Renard E" first="Eric" last="Renard">Eric Renard</name>
<affiliation wicri:level="3"><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>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</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>
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</author>
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<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>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Blood Glucose (metabolism)</term>
<term>Clinical Trials as Topic</term>
<term>Consensus</term>
<term>Diabetes Mellitus, Type 1 (blood)</term>
<term>Diabetes Mellitus, Type 1 (therapy)</term>
<term>Hemoglobin A, Glycosylated (analysis)</term>
<term>Humans</term>
<term>Outcome Assessment (Health Care) (methods)</term>
<term>Pancreas, Artificial</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Consensus</term>
<term>Diabète de type 1 ()</term>
<term>Diabète de type 1 (sang)</term>
<term>Essais cliniques comme sujet</term>
<term>Glycémie (métabolisme)</term>
<term>Humains</term>
<term>Hémoglobine A glycosylée (analyse)</term>
<term>Pancréas artificiel</term>
<term>Évaluation de résultat (soins) ()</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>Hemoglobin A, Glycosylated</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Blood Glucose</term>
</keywords>
<keywords scheme="MESH" qualifier="analyse" xml:lang="fr"><term>Hémoglobine A glycosylée</term>
</keywords>
<keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Diabetes Mellitus, Type 1</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Outcome Assessment (Health Care)</term>
</keywords>
<keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Glycémie</term>
</keywords>
<keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Diabète de type 1</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Diabetes Mellitus, Type 1</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term>
<term>Consensus</term>
<term>Humans</term>
<term>Pancreas, Artificial</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Consensus</term>
<term>Diabète de type 1</term>
<term>Essais cliniques comme sujet</term>
<term>Humains</term>
<term>Pancréas artificiel</term>
<term>Évaluation de résultat (soins)</term>
</keywords>
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<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>
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<author><name sortKey="Zisser, Hc" uniqKey="Zisser H">HC Zisser</name>
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<author><name sortKey="Bushnell, Dm" uniqKey="Bushnell D">DM Bushnell</name>
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<author><name sortKey="Thomsen, Tl" uniqKey="Thomsen T">TL Thomsen</name>
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<author><name sortKey="Wolden, M" uniqKey="Wolden M">M Wolden</name>
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<author><name sortKey="Simonson, Dc" uniqKey="Simonson D">DC Simonson</name>
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</author>
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<author><name sortKey="Cobelli, C" uniqKey="Cobelli C">C Cobelli</name>
</author>
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<author><name sortKey="Haidar, A" uniqKey="Haidar A">A Haidar</name>
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</author>
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<author><name sortKey="Lum, J" uniqKey="Lum J">J Lum</name>
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<author><name sortKey="Aldred, C" uniqKey="Aldred C">C Aldred</name>
</author>
<author><name sortKey="Oliver, N" uniqKey="Oliver N">N Oliver</name>
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<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Israël</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
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<region><li>Angleterre</li>
<li>Angleterre de l'Est</li>
<li>Californie</li>
<li>Colorado</li>
<li>Connecticut</li>
<li>Floride</li>
<li>Hollande-Septentrionale</li>
<li>Illinois</li>
<li>Languedoc-Roussillon</li>
<li>Massachusetts</li>
<li>Occitanie (région administrative)</li>
<li>Oregon</li>
<li>Pennsylvanie</li>
<li>Québec</li>
<li>Victoria (État)</li>
<li>Virginie</li>
<li>État de New York</li>
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<settlement><li>Amsterdam</li>
<li>Cambridge</li>
<li>Melbourne</li>
<li>Montpellier</li>
<li>Montréal</li>
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<li>Université d'Amsterdam</li>
<li>Université de Cambridge</li>
<li>Université de Melbourne</li>
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<name sortKey="Zisser, Howard" sort="Zisser, Howard" uniqKey="Zisser H" first="Howard" last="Zisser">Howard Zisser</name>
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<name sortKey="Haidar, Ahmad" sort="Haidar, Ahmad" uniqKey="Haidar A" first="Ahmad" last="Haidar">Ahmad Haidar</name>
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<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>
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<country name="France"><region name="Occitanie (région administrative)"><name sortKey="Renard, Eric" sort="Renard, Eric" uniqKey="Renard E" first="Eric" last="Renard">Eric Renard</name>
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Serveur d'exploration sur les relations entre la France et l'Australie

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

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	Serveur d'exploration sur les relations entre la France et l'Australie
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