Where can I find a list of valid glucometers approved by regulatory bodies such as the United States (US) Food and Drug Administration (FDA) or the European Medicines Agency (EMA)?

Where to Check Valid Glucometers

The Diabetes Technology Society Blood Glucose Monitoring System Surveillance Program (www.diabetestechnology.org/surveillance/) provides independent verification of which glucometers meet FDA accuracy standards, as only 6 of the top 18 best-selling meters initially met accuracy requirements, though this improved to 14 of 18 in subsequent testing. 1

Primary Resources for Verified Glucometers

United States (FDA-Approved Devices)

• Only use meters that are FDA-cleared and meet current FDA accuracy standards, which require 95% of readings within 15% for home use and 99% within 20% across the usable glucose range 1, 2
• The Diabetes Technology Society Surveillance Program is the only independent source that tests whether FDA-cleared meters actually meet their claimed accuracy standards in real-world conditions 1
• Purchase test strips only from pharmacies or licensed distributors, never secondhand or preowned strips, as these may give incorrect results 1

Europe (CE-Marked Devices)

• In Europe, currently marketed meters must meet ISO 15197:2013 standards, which require 95% of readings within 15% for glucose ≥100 mg/dL or within 15 mg/dL for glucose <100 mg/dL 1
• Each EU member state maintains its own national pharmaceutical regulatory authority under European Commission oversight 1

Critical Accuracy Considerations

The FDA Clearance Paradox

A major pitfall is assuming FDA clearance guarantees ongoing accuracy—many widely-used meters fail to meet standards in post-approval testing. 1 The key issues include:

• Meters only need to meet the standard under which they were originally approved, not necessarily current standards 1
• Ongoing accuracy monitoring is left to manufacturers, not independently verified 1
• Substantial variation exists in accuracy among widely-used systems 1

Accuracy Standards Comparison

The FDA maintains stricter standards than ISO for hospital use 1:

• FDA hospital standard: 95% within 12% for glucose ≥75 mg/dL; 95% within 12 mg/dL for glucose <75 mg/dL 1, 2
• ISO hospital standard: 95% within 15% for glucose ≥100 mg/dL; 95% within 15 mg/dL for glucose <100 mg/dL 1

Practical Recommendations for Selecting Meters

Device Selection Algorithm

1. Check the Diabetes Technology Society Surveillance Program website first to verify the specific meter model meets accuracy standards 1
2. Ensure the meter is appropriate for the clinical setting: professional-use meters for hospitals (higher accuracy standards), home-use meters for outpatient management 2
3. Match meter technology to patient factors: use glucose dehydrogenase-based meters for patients with abnormal oxygen saturation, as glucose oxidase meters are affected by oxygen levels 2
4. Verify test strips are unexpired and properly stored, purchased only from pharmacies or licensed distributors 1

Common Pitfalls to Avoid

• Never assume FDA clearance equals accuracy—independent verification through the Diabetes Technology Society program is essential 1
• Avoid purchasing meters based solely on cost or convenience without verifying accuracy through independent testing 1
• Do not use capillary (fingerstick) testing in critically ill patients, those on vasopressors, or with peripheral edema, as accuracy is severely compromised 2
• Never use adult meters for neonates—high hematocrit in newborns significantly affects accuracy and requires neonatal-specific devices 2

Operator Error Prevention

Operator errors exceed instrument errors as the primary source of inaccuracy, including 2:

• Failure to calibrate meters regularly
• Improper use of control solutions
• Poor hand washing and dirty meters
• Improper test strip storage (exposure to heat, humidity, or air)

Education significantly reduces user inaccuracies, and regular calibration protocols with proper strip handling are essential 2