Rethinking the safety and efficacy assessment of (Hybrid) Closed Loop systems: Should we promote the need for a minimum of exercise data within the regulatory approval?

Othmar Moser^{1

2}, John S Pemberton³

Affiliations

¹ Department of Exercise Physiology and Metabolism, University of Bayreuth, Bayreuth, Germany.
² Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
³ Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's, and Children's NHS Foundation Trust, Birmingham, UK.

Editorial

Othmar Moser et al. Diabet Med. 2024 Mar.

. 2024 Mar;41(3):e15305.

doi: 10.1111/dme.15305. Epub 2024 Feb 8.

Othmar Moser^{1

2}, John S Pemberton³

¹ Department of Exercise Physiology and Metabolism, University of Bayreuth, Bayreuth, Germany.
² Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
³ Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's, and Children's NHS Foundation Trust, Birmingham, UK.

No abstract available

References

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1. Klonoff DC, James Petisce FR, Bailey TS, et al. Performance Metrics for Continuous Interstitial Glucose Monitoring Suggested Citation. Published online 2020. Accessed February 3, 2024 www.clsi.org
1. CFR - Code of Federal Regulations Title 21. Accessed February 3, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?f...
1. Alva S, Brazg R, Castorino K, Kipnes M, Liljenquist DR, Liu H. Accuracy of the third generation of a 14-day continuous glucose monitoring system. Diabetes Ther. 2023;14(4):767-776. doi:10.1007/S13300-023-01385-6
1. Freckmann G, Eichenlaub M, Waldenmaier D, et al. Clinical performance evaluation of continuous glucose monitoring systems: a scoping review and recommendations for reporting. J Diabetes Sci Technol. 2023;17(6):1506-1526. doi:10.1177/19322968231190941