Outcome measures for artificial pancreas clinical trials: A consensus report

David M. Maahs; Bruce A. Buckingham; Jessica R. 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 Renard; Steven J. Russell; Stuart A. Weinzimer; Howard Zisser; John W. Lum

doi:10.2337/dc15-2716

Outcome measures for artificial pancreas clinical trials: A consensus report

David M. Maahs
, Bruce A. Buckingham
, Jessica R. 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 Renard

Steven J. Russell, Stuart A. Weinzimer, Howard Zisser, John W. Lum^*

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Article › peer-review

204 Scopus citations

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 language	English
Pages (from-to)	1175-1179
Number of pages	5
Journal	Diabetes Care
Volume	39
Issue number	7
DOIs	https://doi.org/10.2337/dc15-2716
State	Published - 1 Jul 2016

Funding

Funders	Funder number
National Center for Advancing Translational Sciences	UL1TR001863
National Institute of Diabetes and Digestive and Kidney Diseases	DP3DK101077

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2337/dc15-2716

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Maahs, D. M., Buckingham, B. A., Castle, J. R., 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

@article{37c1e30cc50f4379a1ba2938ddf0544e,

title = "Outcome measures for artificial pancreas clinical trials: A consensus report",

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.",

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

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doi = "10.2337/dc15-2716",

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Maahs, DM, Buckingham, BA, Castle, JR, Cinar, A, Damiano, ER, Dassau, E, Hans De Vries, J, Doyle, FJ, Griffen, SC, Haidar, A, Heinemann, L, Hovorka, R, Jones, TW, Kollman, C, Kovatchev, B, Levy, BL, Nimri, R, O'Neal, DN, Philip, M, Renard, E, Russell, SJ, Weinzimer, SA, Zisser, H & Lum, JW 2016, 'Outcome measures for artificial pancreas clinical trials: A consensus report', Diabetes Care, vol. 39, no. 7, pp. 1175-1179. https://doi.org/10.2337/dc15-2716

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T1 - Outcome measures for artificial pancreas clinical trials

T2 - A consensus report

AU - Maahs, David M.

AU - Buckingham, Bruce A.

AU - Castle, Jessica R.

AU - Cinar, Ali

AU - Damiano, Edward R.

AU - Dassau, Eyal

AU - Hans De Vries, J.

AU - Doyle, Francis J.

AU - Griffen, Steven C.

AU - Haidar, Ahmad

AU - Heinemann, Lutz

AU - Hovorka, Roman

AU - Jones, Timothy W.

AU - Kollman, Craig

AU - Kovatchev, Boris

AU - Levy, Brian L.

AU - Nimri, Revital

AU - O'Neal, David N.

AU - Philip, Moshe

AU - Renard, Eric

AU - Russell, Steven J.

AU - Weinzimer, Stuart A.

AU - Zisser, Howard

AU - Lum, John W.

PY - 2016/7/1

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AB - 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.

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ER -

Outcome measures for artificial pancreas clinical trials: A consensus report

Abstract

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UN SDGs

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