Regulation Catches Up to Reality: Nonadjunctive Use of Continuous Glucose Monitoring Data
Open accessAbstract
The FDA recently conducted an Advisory Panel meeting to evaluate the safety, efficacy, and benefits of granting a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system. If approved, this claim will allow users to make day-to-day treatment decisions, including insulin dosing directly from the glucose values and rate of changes arrows generated by the CGM device, without the requirement of a confirmatory measurement with a self-monitoring blood glucose (SMBG) meter. Sporadic SMBG testing gives limited data, while CGM gives a value every 5 minutes and has alerts, alarms, trending information and allows caregivers to follow the user in real time 24/7. This indication will lead to more wide spread use of CGM and improve overall care with protection of hypoglycemia.
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Since 2015, some rtCGM devices have received regulatory approval for therapeutic use, meaning rtCGM measurements may be used for making therapeutic decisions such as insulin dosing.
“Since 2015, some rtCGM devices have also received regulatory approval for therapeutic use, which means that rtCGM measurements may be used for making therapeutic decisions, such as insulin dosing [19].”
From Advanced Diabetes Management Using Artificial Intelligence and Continuous Glucose Monitoring Sensors (2020) · cites this paper as [19]
Cites
Miller, K. M., Foster, N. C., Beck, R. W., Bergenstal, R. M., DuBose, S. N., DiMeglio, L. A., Maahs, D. M., & Tamborlane, W. V. (2015) · Diabetes Care · doi:10.2337/dc15-0078 · Cited by 1,254 · see citing works
The UVA/PADOVA Type 1 Diabetes Simulator: New Features
Man, C. D., Micheletto, F., Lv, D., Breton, M., Kovatchev, B., & Cobelli, C. (2014) · Journal of Diabetes Science and Technology · doi:10.1177/1932296813514502 · Cited by 791 · see citing works
<i>In Silico</i> Preclinical Trials: A Proof of Concept in Closed-Loop Control of Type 1 Diabetes
Kovatchev, B. P., Breton, M., Dalla Man, C., & Cobelli, C. (2009) · Journal of Diabetes Science and Technology · doi:10.1177/193229680900300106 · Cited by 760 · see citing works
The T1D exchange clinic registry
Beck, R. W., Tamborlane, W. V., Bergenstal, R. M., Miller, K. M., DuBose, S. N., Hall, C. A., & for the T1D Exchange Clinic Network (2012) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2012-1561 · Cited by 456 · see citing works
Šoupal, J., Škrha, J., Fajmon, M., Horová, E., Mráz, M., Škrha, J., & Prázný, M. (2014) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2013.0205 · Cited by 120 · see citing works
Pettus, J., & Edelman, S. V. (2016) · Journal of Diabetes Science and Technology · doi:10.1177/1932296816663747 · Cited by 120 · see citing works
Self-citationViceconti, M., Cobelli, C., Haddad, T. D., Himes, A. K., Kovatchev, B. P., & Palmer, M. (2017) · Proceedings of the Institution of Mechanical Engineers Part H Journal of Engineering in Medicine · doi:10.1177/0954411917702931 · Cited by 63 · see citing works
Visentin, R., Giegerich, C., Jäger, R., Dahmen, R., Boss, A., Grant, M., Dalla Man, C., Cobelli, C., & Klabunde, T. (2016) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2016.0128 · Cited by 36 · see citing works
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Continuous glucose monitoring: a review of recent studies demonstrating improved glycemic outcomes
Rodbard, D. (2017) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0035 · Cited by 458 · see citing works
Wearable Continuous Glucose Monitoring Sensors: A Revolution in Diabetes Treatment
Cappon, G., Acciaroli, G., Vettoretti, M., Facchinetti, A., & Sparacino, G. (2017) · Electronics · doi:10.3390/electronics6030065 · Cited by 242 · see citing works
ISPAD Clinical Practice Consensus Guidelines 2018: diabetes technologies
Sherr, J. L., Tauschmann, M., Battelino, T., de Bock, M., Forlenza, G., Roman, R., Hood, K. K., & Maahs, D. M. (2018) · Pediatric Diabetes · doi:10.1111/pedi.12731 · Cited by 197 · see citing works
Continuous glucose monitoring sensors: past, present and future algorithmic challenges
Facchinetti, A. (2016) · Sensors · doi:10.3390/s16122093 · Cited by 176 · see citing works
Advanced Diabetes Management Using Artificial Intelligence and Continuous Glucose Monitoring Sensors
Vettoretti, M., Cappon, G., Facchinetti, A., & Sparacino, G. (2020) · Sensors · doi:10.3390/s20143870 · Cited by 176 · see citing works
Technology in the management of type 1 diabetes mellitus — current status and future prospects
Tauschmann, M., & Hovorka, R. (2018) · Nature Reviews Endocrinology · doi:10.1038/s41574-018-0044-y · Cited by 161 · see citing works
Acciaroli, G., Vettoretti, M., Facchinetti, A., & Sparacino, G. (2018) · Biosensors · doi:10.3390/bios8010024 · Cited by 122 · see citing works
Scholten, K., & Meng, E. F. (2018) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2018.02.022 · Cited by 103 · see citing works
Continuous glucose monitoring: Current use in diabetes management and possible future applications
Vettoretti, M., Cappon, G., Acciaroli, G., Facchinetti, A., & Sparacino, G. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818774078 · Cited by 96 · see citing works
Yoo, J. H., & Kim, J. H. (2023) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2022.0271 · Cited by 93 · see citing works
Contreras, I., Oviedo, S., Vettoretti, M., VISENTIN, R., & Vehı́, J. (2017) · PLoS ONE · doi:10.1371/journal.pone.0187754 · Cited by 80 · see citing works
Viceconti, M., Cobelli, C., Haddad, T. D., Himes, A. K., Kovatchev, B. P., & Palmer, M. (2017) · Proceedings of the Institution of Mechanical Engineers Part H Journal of Engineering in Medicine · doi:10.1177/0954411917702931 · Cited by 63 · see citing works
Cappon, G., Vettoretti, M., Marturano, F., Facchinetti, A., & Sparacino, G. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818759558 · Cited by 62 · see citing works
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Noaro, G., Cappon, G., Vettoretti, M., Sparacino, G., Favero, S. D., & Facchinetti, A. (2021) · IEEE Transactions on Biomedical Engineering · doi:10.1109/tbme.2020.3004031 · Cited by 57 · see citing works
Vettoretti, M., & Facchinetti, A. (2019) · BioMedical Engineering OnLine · doi:10.1186/s12938-019-0658-x · Cited by 52 · see citing works
Forlenza, G. P., Argento, N. B., & Laffel, L. M. (2017) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0034 · Cited by 47 · see citing works
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Visentin, R., Schiavon, M., Giegerich, C., Klabunde, T., Man, C. D., & Cobelli, C. (2019) · IEEE Transactions on Biomedical Engineering · doi:10.1109/tbme.2019.2897851 · Cited by 22 · see citing works
Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?
Shapiro, A. R. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296816688303 · Cited by 22 · see citing works
Acciaroli, G., Vettoretti, M., Facchinetti, A., & Sparacino, G. (2017) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0297 · Cited by 22 · see citing works
Cobelli, C., & Man, C. D. (2021) · Journal of Diabetes Science and Technology · doi:10.1177/19322968211015268 · Cited by 21 · see citing works
Yet Another Glucose Variability Index: Time for a Paradigm Change?
Cobelli, C., & Facchinetti, A. (2018) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0397 · Cited by 20 · see citing works
Schiavon, M., VISENTIN, R., Giegerich, C., Sieber, J., Man, C. D., Cobelli, C., & Klabunde, T. (2020) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2020.0027 · Cited by 19 · see citing works
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A Model of Self-Monitoring Blood Glucose Measurement Error
Vettoretti, M., Facchinetti, A., Sparacino, G., & Cobelli, C. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817698498 · Cited by 18 · see citing works
Faggionato, E., Schiavon, M., & Dalla Man, C. (2021) · Metabolites · doi:10.3390/metabo11040235 · Cited by 15 · see citing works
Federated multimodal AI for precision-equitable diabetes care
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Anti-biofouling strategies for implantable biosensors of continuous glucose monitoring systems
Yan, Z., Shi, D., & Wang, Z. (2023) · Frontiers of Chemical Science and Engineering · doi:10.1007/s11705-023-2340-x · Cited by 9 · see citing works
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Sperling, M. A., Wolfsdorf, J. I., Menon, R. K., Tamborlane, W. V., Maahs, D. M., Battelino, T., & Phillip, M. (2021) · Elsevier eBooks · doi:10.1016/b978-0-323-62520-3.00021-x · Cited by 9 · see citing works
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VISENTIN, R., Schiavon, M., Bonet, J., Riz, M., Wagenhuber, B., & Man, C. D. (2024) · IEEE Transactions on Biomedical Engineering · doi:10.1109/tbme.2024.3352153 · Cited by 8 · see citing works
VISENTIN, R., Schiavon, M., & Man, C. D. (2020) · Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) · doi:10.1109/embc44109.2020.9175271 · Cited by 6 · see citing works
Noaro, G., Cappon, G., Sparacino, G., Boscari, F., Bruttomesso, D., & Facchinetti, A. (2021) · Journal of Diabetes Science and Technology · doi:10.1177/19322968211043162 · Cited by 6 · see citing works
Schiavon, M., Acciaroli, G., Vettoretti, M., Giaretta, A., & Visentin, R. (2018) · 2018 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) · doi:10.1109/embc.2018.8512257 · Cited by 5 · see citing works
Implantable biosensors: Advancements and applications
Nirwal, G. K., Wu, K. Y., Ramnawaz, T., Xu, Y., Carbonneau, M., Nguyen, B. H., & Tran, S. D. (2025) · Progress in molecular biology and translational science · doi:10.1016/bs.pmbts.2025.06.006 · Cited by 5 · see citing works
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Hermanns, N., Ehrmann, D., & Kulzer, B. (2016) · Journal of Diabetes Science and Technology · doi:10.1177/1932296816677578 · Cited by 4 · see citing works
Artificial intelligence-based decision support systems for diabetes
Contreras, I., Bertachi, A. H., Biagi, L., Oviedo, S., Ramkissoon, C. M., & Vehı́, J. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-817133-2.00014-8 · Cited by 4 · see citing works
Welsh, J. B., Walker, T. C., & Price, D. A. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817694180 · Cited by 3 · see citing works
Price, D. A. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817695341 · Cited by 3 · see citing works
Cappon, G., Vettoretti, M., Marturano, F., Facchinetti, A., & Sparacino, G. (2018) · Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) · doi:10.1109/embc.2018.8512250 · Cited by 2 · see citing works
Free-living use of artificial pancreas for children with type 1 diabetes: systematic review
Dovč, K., Mutlu, G. Y., Philippov, Y. I., Лаптев, Д. Н., Patrakeeva, E. M., Chernilova, L. O., Zalevskaya, A. G., Shestakova, M. V., & Battelino, T. (2018) · Diabetes Mellitus · doi:10.14341/dm9714 · Cited by 2 · see citing works
Modeling the SMBG measurement error
Vettoretti, M. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-816714-4.00005-3 · Cited by 1 · see citing works
Clinical Studies on Efficacy of Continuous Glucose Monitoring
Cherubini, V. (2020) · Springer eBooks · doi:10.1007/978-3-030-42806-8_4
- Authors
- Edelman, S. V.
- Affiliations
- University of California San Diego (US)
- Corresponding author
- Edelman, Steven V.
- ORCID
- Edelman, Steven V.
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2016-09-25
- Volume
- 11
- Issue
- 1
- Pages
- 160-164
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC5375077
- OpenAlex
- W2520537712
- Semantic Scholar
- a4628944c31803c2cb42181ed7b623ec5bc4d27a
- Cited by
- 51
- References
- 8
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 5 · 2020: 8 · 2019: 2 · 2018: 13 · 2017: 14 · 2016: 2
- FWCI
- 10.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- continuous glucose monitoring, FDA advisory committee, self-monitoring of blood glucose, insulin dose, hypoglycemia prevention, diabetes management, regulatory approval
- MeSH terms
- Blood Glucose, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Insulin, United States, United States Food and Drug Administration, Blood Glucose Self-Monitoring, Device Approval
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