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Glucose meter performance criteria for tight glycemic control estimated by simulation modeling
Brad S Karon1, James C Boyd, George G Klee
1Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USA.
Clinical Chemistry
|June 1, 2010
Summary
Glucose meter accuracy is crucial for safe tight glycemic control (TGC). Meters with 15% total allowable error (TEa) minimize large insulin dosing errors, while 10% TEa may reduce smaller errors. Current 20% TEa standards may be insufficient.
Area of Science:
- Medical Devices
- Clinical Informatics
- Endocrinology
Background:
- Establishing analytical performance criteria for glucose meters is essential for safe tight glycemic control (TGC).
- Current criteria may not adequately address the risks associated with insulin dosing errors during TGC.
- Simulation modeling is used to assess the impact of glucose meter accuracy on patient safety.
Purpose of the Study:
- To evaluate the relationship between glucose meter analytical performance and insulin dosing errors in patients undergoing TGC.
- To determine the impact of different total allowable error (TEa) criteria on the frequency and severity of insulin dosing errors.
Main Methods:
- Utilized a dataset of 29,920 glucose values from patients on TGC.
- Employed two simulation models to assess insulin dosing errors under 10%, 15%, and 20% TEa criteria.
- Analyzed the frequency of one- to three-category insulin dosing errors.
Main Results:
- One-category insulin dosing errors were frequent across all tested TEa levels.
- Two-category errors increased with higher TEa (15% and 20%) compared to 10% TEa.
- Three-category errors, posing the highest risk of hypoglycemia, were infrequent except under the 20% TEa condition.
Conclusions:
- Glucose meters meeting a 15% TEa are unlikely to cause significant insulin dosing errors during TGC.
- Improving accuracy to 10% TEa could decrease the incidence of two-category dosing errors.
- The current 20% TEa standard for glucose meters may not be optimal for ensuring patient safety during TGC.
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