Cited by 51Diabetes Management and ResearchHealthcare RegulationDiabetes Treatment and Management

Regulation Catches Up to Reality: Nonadjunctive Use of Continuous Glucose Monitoring Data

Open access
Edelman, Steven V.·2017·Journal of Diabetes Science and Technology

Abstract

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.

Integrity signals

Registry

Crossref · 10.1177/1932296816667749

Cites

8 of 8 references verified0 citation errors · 0 not checkable

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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].”

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Authors
Edelman, S. V.
Affiliations
University of California San Diego (US)
Corresponding author
Edelman, Steven V.
Venue
Journal of Diabetes Science and Technology
Published
2016-09-25
Volume
11
Issue
1
Pages
160-164
ISSN
1932-2968 (ISSN-L)
OpenAlex
W2520537712
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
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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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