Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations: A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

被引:106
作者
Petrie, John R. [1 ]
Peters, Anne L. [2 ]
Bergenstal, Richard M. [3 ]
Holl, Reinhard W. [4 ]
Fleming, G. Alexander [5 ]
Heinemann, Lutz [6 ]
机构
[1] Univ Glasgow, Inst Cardiovasc & Med Sci, Glasgow, Lanark, Scotland
[2] Univ Southern Calif, Keck Sch Med, Los Angeles, CA 90033 USA
[3] Int Diabet Ctr Pk Nicollet, Minneapolis, MN USA
[4] Univ Ulm, Inst Epidemiol & Med Biometry, Ulm, Germany
[5] Kinexum, Harpers Ferry, WV USA
[6] Science & Co, Dusseldorf, Germany
关键词
GLUCOSE-SENSING TECHNOLOGY; INSULIN SUSPENSION; MONITORING-SYSTEM; ENDOCRINE-SOCIETY; OUTCOME MEASURES; OPEN-LABEL; HYPOGLYCEMIA; MULTICENTER; SAFETY; ENDOCRINOLOGISTS;
D O I
10.2337/dci17-0043
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.
引用
收藏
页码:1614 / 1621
页数:8
相关论文
共 59 条
[1]
Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange [J].
Agiostratidou, Gina ;
Anhalt, Henry ;
Ball, Dana ;
Blonde, Lawrence ;
Gourgari, Evgenia ;
Harriman, Karen N. ;
Kowalski, Aaron J. ;
Madden, Paul ;
McAuliffe-Fogarty, Alicia H. ;
McElwee-Malloy, Molly ;
Peters, Anne ;
Raman, Sripriya ;
Reifschneider, Kent ;
Rubin, Karen ;
Weinzimer, Stuart A. .
DIABETES CARE, 2017, 40 (12) :1622-1630
[2]
REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes [J].
Aleppo, Grazia ;
Ruedy, Katrina J. ;
Riddlesworth, Tonya D. ;
Kruger, Davida F. ;
Peters, Anne L. ;
Hirsch, Irl ;
Bergenstal, Richard M. ;
Toschi, Elena ;
Ahmann, Andrew J. ;
Shah, Viral N. ;
Rickels, Michael R. ;
Bode, Bruce W. ;
Philis-Tsimikas, Athena ;
Pop-Busui, Rodica ;
Rodriguez, Henry ;
Eyth, Emily ;
Bhargava, Anuj ;
Kollman, Craig ;
Beck, Roy W. .
DIABETES CARE, 2017, 40 (04) :538-545
[3]
Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes [J].
Amiel, Stephanie A. ;
Aschner, Pablo ;
Childs, Belinda ;
Cryer, Philip E. ;
de Galan, Bastiaan E. ;
Heller, Simon R. ;
Gonder-Frederick, Linda ;
Frier, Brian M. ;
Jones, Timothy ;
Khunti, Kamlesh ;
Leiter, Lawrence A. ;
McCrimmon, Rory J. ;
Luo, Yingying ;
Seaquist, Elizabeth R. ;
Vigersky, Robert ;
Zoungas, Sophia .
DIABETES CARE, 2017, 40 (01) :155-157
[4]
Multinational Home Use of Closed-Loop Control Is Safe and Effective [J].
Anderson, Stacey M. ;
Raghinaru, Dan ;
Pinsker, Jordan E. ;
Boscari, Federico ;
Renard, Eric ;
Buckingham, Bruce A. ;
Nimri, Revital ;
Doyle, Francis J., III ;
Brown, Sue A. ;
Keith-Hynes, Patrick ;
Breton, Marc D. ;
Chernavvsky, Daniel ;
Bevier, Wendy C. ;
Bradley, Paige K. ;
Bruttomesso, Daniela ;
Del Favero, Simone ;
Calore, Roberta ;
Cobelli, Claudio ;
Avogaro, Angelo ;
Farret, Anne ;
Place, Jerome ;
Ly, Trang T. ;
Shanmugham, Satya ;
Phillip, Moshe ;
Dassau, Eyal ;
Dasanayake, Isuru S. ;
Kollman, Craig ;
Lum, John W. ;
Beck, Roy W. ;
Kovatchev, Boris .
DIABETES CARE, 2016, 39 (07) :1143-1150
[5]
AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2016 OUTPATIENT GLUCOSE MONITORING CONSENSUS STATEMENT (vol 22, pg 231, 2016) [J].
Bailey, Timothy S. .
ENDOCRINE PRACTICE, 2016, 22 (02) :231-261
[6]
Patient-Reported Outcomes and Continuous Glucose Monitoring: Can We Do Better With Artificial Pancreas Devices? [J].
Barnard, Katharine D. ;
Kubiak, Thomas ;
Hermanns, Norbert ;
Heinemann, Lutz .
DIABETES CARE, 2015, 38 (05) :E70-E70
[7]
Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections The DIAMOND Randomized Clinical Trial [J].
Beck, Roy W. ;
Riddlesworth, Tonya ;
Ruedy, Katrina ;
Ahmann, Andrew ;
Bergenstal, Richard ;
Haller, Stacie ;
Kollman, Craig ;
Kruger, Davida ;
McGill, Janet B. ;
Polonsky, William ;
Toschi, Elena ;
Wolpert, Howard ;
Price, David .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 317 (04) :371-378
[8]
Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes [J].
Bergenstal, Richard M. ;
Garg, Satish ;
Weinzimer, Stuart A. ;
Buckingham, Bruce A. ;
Bode, Bruce W. ;
Tamborlane, William V. ;
Kaufman, Francine R. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 316 (13) :1407-1408
[9]
Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia [J].
Bergenstal, Richard M. ;
Klonoff, David C. ;
Garg, Satish K. ;
Bode, Bruce W. ;
Meredith, Melissa ;
Slover, Robert H. ;
Ahmann, Andrew J. ;
Welsh, John B. ;
Lee, Scott W. ;
Kaufman, Francine R. .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (03) :224-232
[10]
Recommendations for Standardizing Glucose Reporting and Analysis to Optimize Clinical Decision Making in Diabetes: The Ambulatory Glucose Profile (AGP) [J].
Bergenstal, Richard M. ;
Ahmann, Andrew J. ;
Bailey, Timothy ;
Beck, Roy W. ;
Bissen, Joan ;
Buckingham, Bruce ;
Deeb, Larry ;
Dolin, Robert H. ;
Garg, Satish K. ;
Goland, Robin ;
Hirsch, Irl B. ;
Klonoff, David C. ;
Kruger, Davida F. ;
Matfin, Glenn ;
Mazze, Roger S. ;
Olson, Beth A. ;
Parkin, Christopher ;
Peters, Anne ;
Powers, Margaret A. ;
Rodriguez, Henry ;
Southerland, Phil ;
Strock, Ellie S. ;
Tamborlane, William ;
Wesley, David M. .
DIABETES TECHNOLOGY & THERAPEUTICS, 2013, 15 (03) :198-211