Viral Vitalism

Source Library

FDA clears first over-the-counter continuous glucose monitor

Official FDA clearance source for the OTC CGM boundary: intended population, hypoglycemia limitation, and medical-decision warning.

GovernmentU.S. health regulator
Source type
Government
Access type
Official
Publisher
U.S. Food and Drug Administration
Date
2024-03-05
Added
2026-07-06
Updated
2026-07-06

Trust profile

VV Source Trust Matrix v1.0

VV Source Trust Matrix v1.0 asks whether this source is trustworthy for the claim lane being used, not whether every possible claim from it is equally strong.

94

U.S. health regulator

Publisher type
Regulator
Bias profile
Low

This source is strongest for regulatory status and safety and weaker for consumer context and trial discovery.

VV Source Fit Score 1.0

Fit by use case

Fit scores are role-specific. A source can be excellent for one claim lane and weak for another.

Frameworks ->
Regulatory status
98/100
Primary Anchor
Clinical outcomes
84/100
Strong Support
Mechanism
68/100
Context Source
Safety
95/100
Primary Anchor
Consumer context
68/100
Context Source
Trial discovery
68/100
Context Source

Best used for

  • Approvals
  • Labels
  • Safety communications

Weak for

  • Comparative effectiveness
  • Consumer experience

Used in Viral Vitalism

Related studies

Related sources

OtherGeneral published source

Dexcom Stelo product information

Commercial source for product-positioning language, useful only to compare claims against FDA clearance and independent evidence.

Trust score
60
Publisher
Dexcom
Access
Publisher
Usage
2 connections
Inspect source ->
Clinical resourceProfessional clinical guidance

ADA Standards of Care: Diabetes technology

Professional guidance source for diabetes-technology context and why medical CGM use should not be flattened into wellness tracking.

Trust score
82
Publisher
Diabetes Care
Access
Publisher
Usage
6 connections
Inspect source ->

Topic tags

cgmsteloover-the-countermedical-deviceregulatory-context

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