Outcome measures for artificial pancreas clinical trials: A consensus report

David M. Maahs, Bruce A. Buckingham, Jessica Castle, Ali Cinar, Edward R. Damiano, Eyal Dassau, J. Hans De Vries, Francis J. Doyle, Steven C. Griffen, Ahmad Haidar, Lutz Heinemann, Roman Hovorka, Timothy W. Jones, Craig Kollman, Boris Kovatchev, Brian L. Levy, Revital Nimri, David N. O'Neal, Moshe Philip, Eric RenardSteven J. Russell, Stuart A. Weinzimer, Howard Zisser, John W. Lum

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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 thewider AP community 1) advocate for the use of continuous glucose monitoring glucosemetrics as outcomemeasures 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.

Original languageEnglish (US)
Pages (from-to)1175-1179
Number of pages5
JournalDiabetes Care
Volume39
Issue number7
DOIs
StatePublished - Jul 1 2016

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ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Maahs, D. M., Buckingham, B. A., Castle, J., Cinar, A., Damiano, E. R., Dassau, E., Hans De Vries, J., Doyle, F. J., Griffen, S. C., Haidar, A., Heinemann, L., Hovorka, R., Jones, T. W., Kollman, C., Kovatchev, B., Levy, B. L., Nimri, R., O'Neal, D. N., Philip, M., ... Lum, J. W. (2016). Outcome measures for artificial pancreas clinical trials: A consensus report. Diabetes Care, 39(7), 1175-1179. https://doi.org/10.2337/dc15-2716