Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.
Identifieur interne : 000420 ( Main/Exploration ); précédent : 000419; suivant : 000421Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.
Auteurs : Oliver Schnell [Allemagne] ; Katharine Barnard [Royaume-Uni] ; Richard Bergenstal [États-Unis] ; Emanuele Bosi [Italie] ; Satish Garg [États-Unis] ; Bruno Guerci [France] ; Thomas Haak [Allemagne] ; Irl B. Hirsch [États-Unis] ; Linong Ji [République populaire de Chine] ; Shashank R. Joshi [Inde] ; Maarten Kamp [Australie] ; Lori Laffel [États-Unis] ; Chantal Mathieu [Belgique] ; William H. Polonsky [États-Unis] ; Frank Snoek [Pays-Bas] ; Philip Home [Royaume-Uni]Source :
- Diabetes technology & therapeutics [ 1557-8593 ] ; 2017.
Abstract
Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.
DOI: 10.1089/dia.2017.0054
PubMed: 28530490
Affiliations:
- Allemagne, Australie, Belgique, France, Inde, Italie, Pays-Bas, Royaume-Uni, République populaire de Chine, États-Unis
- Californie, Colorado, Grand Est, Hollande-Septentrionale, Lombardie, Lorraine (région), Massachusetts, Minnesota, Washington (État)
- Amsterdam, Milan, Nancy, Vandœuvre-lès-Nancy
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Le document en format XML
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.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>1 Forschergruppe Diabetes e.V., Helmholtz Zentrum, Munich </wicri:regionArea><wicri:noRegion>Munich </wicri:noRegion><wicri:noRegion>Munich </wicri:noRegion><wicri:noRegion>Munich </wicri:noRegion></affiliation></author><author><name sortKey="Barnard, Katharine" sort="Barnard, Katharine" uniqKey="Barnard K" first="Katharine" last="Barnard">Katharine Barnard</name><affiliation wicri:level="1"><nlm:affiliation>2 Bournemouth University , Faculty of Health and Social Science, Bournemouth, United Kingdom .</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>2 Bournemouth University , Faculty of Health and Social Science, Bournemouth</wicri:regionArea><wicri:noRegion>Bournemouth</wicri:noRegion></affiliation></author><author><name sortKey="Bergenstal, Richard" sort="Bergenstal, Richard" uniqKey="Bergenstal R" first="Richard" last="Bergenstal">Richard Bergenstal</name><affiliation wicri:level="2"><nlm:affiliation>3 International Diabetes Center , Minneapolis, Minnesota.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>3 International Diabetes Center , Minneapolis</wicri:cityArea></affiliation></author><author><name sortKey="Bosi, Emanuele" sort="Bosi, Emanuele" uniqKey="Bosi E" first="Emanuele" last="Bosi">Emanuele Bosi</name><affiliation wicri:level="3"><nlm:affiliation>4 Vita-Salute San Raffaele University , Department of General Medicine-Diabetes & Endocrinology Unit, Milan, Italy .</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>4 Vita-Salute San Raffaele University , Department of General Medicine-Diabetes & Endocrinology Unit, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Garg, Satish" sort="Garg, Satish" uniqKey="Garg S" first="Satish" last="Garg">Satish Garg</name><affiliation wicri:level="2"><nlm:affiliation>5 Barbara Davis Center for Diabetes, University of Colorado Denver , Denver, Colorado.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Colorado</region></placeName><wicri:cityArea>5 Barbara Davis Center for Diabetes, University of Colorado Denver , Denver</wicri:cityArea></affiliation></author><author><name sortKey="Guerci, Bruno" sort="Guerci, Bruno" uniqKey="Guerci B" first="Bruno" last="Guerci">Bruno Guerci</name><affiliation wicri:level="3"><nlm:affiliation>6 Centre Hospitalier Universitaire Nancy , Vandoeuvre-Les-Nancy, France .</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>6 Centre Hospitalier Universitaire Nancy , Vandoeuvre-Les-Nancy</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Lorraine (région)</region><settlement type="city">Vandœuvre-lès-Nancy</settlement><settlement type="city" wicri:auto="agglo">Nancy</settlement></placeName></affiliation></author><author><name sortKey="Haak, Thomas" sort="Haak, Thomas" uniqKey="Haak T" first="Thomas" last="Haak">Thomas Haak</name><affiliation wicri:level="1"><nlm:affiliation>7 Diabetes Center Mergentheim , Bad Mergentheim, Germany .</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>7 Diabetes Center Mergentheim , Bad Mergentheim</wicri:regionArea><wicri:noRegion>Bad Mergentheim</wicri:noRegion><wicri:noRegion>Bad Mergentheim</wicri:noRegion><wicri:noRegion>Bad Mergentheim</wicri:noRegion></affiliation></author><author><name sortKey="Hirsch, Irl B" sort="Hirsch, Irl B" uniqKey="Hirsch I" first="Irl B" last="Hirsch">Irl B. Hirsch</name><affiliation wicri:level="2"><nlm:affiliation>8 University of Washington School of Medicine , Division of Metabolism, Endocrinology and Nutrition, Seattle, Washington.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Washington (État)</region></placeName><wicri:cityArea>8 University of Washington School of Medicine , Division of Metabolism, Endocrinology and Nutrition, Seattle</wicri:cityArea></affiliation></author><author><name sortKey="Ji, Linong" sort="Ji, Linong" uniqKey="Ji L" first="Linong" last="Ji">Linong Ji</name><affiliation wicri:level="1"><nlm:affiliation>9 Department of Endocrinology and Metabolism, Peking University People's Hospital , Peking, China .</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>9 Department of Endocrinology and Metabolism, Peking University People's Hospital , Peking</wicri:regionArea><wicri:noRegion>Peking</wicri:noRegion></affiliation></author><author><name sortKey="Joshi, Shashank R" sort="Joshi, Shashank R" uniqKey="Joshi S" first="Shashank R" last="Joshi">Shashank R. Joshi</name><affiliation wicri:level="1"><nlm:affiliation>10 Indian Academy of Diabetes , Ahmedabad, India .</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>10 Indian Academy of Diabetes , Ahmedabad</wicri:regionArea><wicri:noRegion>Ahmedabad</wicri:noRegion></affiliation></author><author><name sortKey="Kamp, Maarten" sort="Kamp, Maarten" uniqKey="Kamp M" first="Maarten" last="Kamp">Maarten Kamp</name><affiliation wicri:level="1"><nlm:affiliation>11 Queensland University of Technology , Faculty of Health, Brisbane, Australia .</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>11 Queensland University of Technology , Faculty of Health, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Laffel, Lori" sort="Laffel, Lori" uniqKey="Laffel L" first="Lori" last="Laffel">Lori Laffel</name><affiliation wicri:level="2"><nlm:affiliation>12 Joslin Diabetes Center , Section on Pediatric, Adolescent and Young Adult Diabetes, Boston, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>12 Joslin Diabetes Center , Section on Pediatric, Adolescent and Young Adult Diabetes, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Mathieu, Chantal" sort="Mathieu, Chantal" uniqKey="Mathieu C" first="Chantal" last="Mathieu">Chantal Mathieu</name><affiliation wicri:level="1"><nlm:affiliation>13 University Hospital Gasthuisberg Leuven , Department of Clinical and Experimental Medicine, Leuven, Belgium .</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>13 University Hospital Gasthuisberg Leuven , Department of Clinical and Experimental Medicine, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Polonsky, William H" sort="Polonsky, William H" uniqKey="Polonsky W" first="William H" last="Polonsky">William H. Polonsky</name><affiliation wicri:level="2"><nlm:affiliation>14 Behavioral Diabetes Institute, University of California , San Diego, San Diego, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>14 Behavioral Diabetes Institute, University of California , San Diego, San Diego</wicri:cityArea></affiliation></author><author><name sortKey="Snoek, Frank" sort="Snoek, Frank" uniqKey="Snoek F" first="Frank" last="Snoek">Frank Snoek</name><affiliation wicri:level="3"><nlm:affiliation>15 Department of Medical Psychology, VU University Medical Center and Academic Medical Center , Amsterdam, The Netherlands .</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>15 Department of Medical Psychology, VU University Medical Center and Academic Medical Center , Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Home, Philip" sort="Home, Philip" uniqKey="Home P" first="Philip" last="Home">Philip Home</name><affiliation wicri:level="1"><nlm:affiliation>16 Institute of Cellular Medicine - Diabetes, Newcastle University , Newcastle upon Tyne, United Kingdom .</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>16 Institute of Cellular Medicine - Diabetes, Newcastle University , Newcastle upon Tyne</wicri:regionArea><wicri:noRegion>Newcastle upon Tyne</wicri:noRegion></affiliation></author></analytic><series><title level="j">Diabetes technology & therapeutics</title><idno type="eISSN">1557-8593</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>France</li><li>Inde</li><li>Italie</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>République populaire de Chine</li><li>États-Unis</li></country><region><li>Californie</li><li>Colorado</li><li>Grand Est</li><li>Hollande-Septentrionale</li><li>Lombardie</li><li>Lorraine (région)</li><li>Massachusetts</li><li>Minnesota</li><li>Washington (État)</li></region><settlement><li>Amsterdam</li><li>Milan</li><li>Nancy</li><li>Vandœuvre-lès-Nancy</li></settlement></list><tree><country name="Allemagne"><noRegion><name sortKey="Schnell, Oliver" sort="Schnell, Oliver" uniqKey="Schnell O" first="Oliver" last="Schnell">Oliver Schnell</name></noRegion><name sortKey="Haak, Thomas" sort="Haak, Thomas" uniqKey="Haak T" first="Thomas" last="Haak">Thomas Haak</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Barnard, Katharine" sort="Barnard, Katharine" uniqKey="Barnard K" first="Katharine" last="Barnard">Katharine Barnard</name></noRegion><name sortKey="Home, Philip" sort="Home, Philip" uniqKey="Home P" first="Philip" last="Home">Philip Home</name></country><country name="États-Unis"><region name="Minnesota"><name sortKey="Bergenstal, Richard" sort="Bergenstal, Richard" uniqKey="Bergenstal R" first="Richard" last="Bergenstal">Richard Bergenstal</name></region><name sortKey="Garg, Satish" sort="Garg, Satish" uniqKey="Garg S" first="Satish" last="Garg">Satish Garg</name><name sortKey="Hirsch, Irl B" sort="Hirsch, Irl B" uniqKey="Hirsch I" first="Irl B" last="Hirsch">Irl B. Hirsch</name><name sortKey="Laffel, Lori" sort="Laffel, Lori" uniqKey="Laffel L" first="Lori" last="Laffel">Lori Laffel</name><name sortKey="Polonsky, William H" sort="Polonsky, William H" uniqKey="Polonsky W" first="William H" last="Polonsky">William H. Polonsky</name></country><country name="Italie"><region name="Lombardie"><name sortKey="Bosi, Emanuele" sort="Bosi, Emanuele" uniqKey="Bosi E" first="Emanuele" last="Bosi">Emanuele Bosi</name></region></country><country name="France"><region name="Grand Est"><name sortKey="Guerci, Bruno" sort="Guerci, Bruno" uniqKey="Guerci B" first="Bruno" last="Guerci">Bruno Guerci</name></region></country><country name="République populaire de Chine"><noRegion><name sortKey="Ji, Linong" sort="Ji, Linong" uniqKey="Ji L" first="Linong" last="Ji">Linong Ji</name></noRegion></country><country name="Inde"><noRegion><name sortKey="Joshi, Shashank R" sort="Joshi, Shashank R" uniqKey="Joshi S" first="Shashank R" last="Joshi">Shashank R. Joshi</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Kamp, Maarten" sort="Kamp, Maarten" uniqKey="Kamp M" first="Maarten" last="Kamp">Maarten Kamp</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Mathieu, Chantal" sort="Mathieu, Chantal" uniqKey="Mathieu C" first="Chantal" last="Mathieu">Chantal Mathieu</name></noRegion></country><country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Snoek, Frank" sort="Snoek, Frank" uniqKey="Snoek F" first="Frank" last="Snoek">Frank Snoek</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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