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Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

Accepted version
Peer-reviewed

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Type

Article

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Authors

Maahs, David M 
Buckingham, Bruce A 
Castle, Jessica R 
Cinar, Ali 
Damiano, Edward R 

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 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.

Description

Keywords

Blood Glucose, Clinical Trials as Topic, Consensus, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Outcome Assessment, Health Care, Pancreas, Artificial

Journal Title

Diabetes Care

Conference Name

Journal ISSN

0149-5992
1935-5548

Volume Title

39

Publisher

American Diabetes Association