Patient-Reported Outcomes and Continuous Glucose Monitoring: Can We Do Better With Artificial Pancreas Devices?
- Katharine D. Barnard1⇑,
- Thomas Kubiak2,
- Norbert Hermanns3 and
- Lutz Heinemann4
- 1Human Development and Health Academic Unit and Clinical and Experimental Sciences Academic Unit, Faculty of Medicine, University of Southampton, Southampton, U.K.
- 2Health Psychology, Johannes Gutenberg University, Mainz, Germany
- 3Diabetes Center Mergentheim, Research Institute Diabetes (FIDAM), Bad Mergentheim, Germany
- 4Science & Co., Düsseldorf, Germany
- Corresponding author: Katharine D. Barnard, k.barnard{at}soton.ac.uk.
Patient-reported outcomes (PROs) assess a person’s experience, feelings, and thoughts about both their condition and its treatment. PROs are able to contribute to a benefit assessment of new medical products by introducing the patients’ subjective evaluation of medical products into the evaluation process. Thus, PROs are also the cornerstone of medical product development for understanding patients’ perceptions on medical products and/or its benefit assessment.
In the past 15 years, PROs were also evaluated in most clinical trials performed with continuous glucose monitoring systems. However, in its recent evaluation of such trials, the German Institute for Quality and Efficiency in Health Care (IQWiG)—which has to provide an evidence-based review of the …