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Cited by 103Diabetes Management and ResearchDiabetes Management and EducationPatient Safety and Medication Errors

Impact of Blood Glucose Self-Monitoring Errors on Glucose Variability, Risk for Hypoglycemia, and Average Glucose Control in Type 1 Diabetes: An In Silico Study

Open access
Breton, Marc D., Kovatchev, Boris P.·2010·Journal of Diabetes Science and Technology
DOI 10.1177/193229681000400309PMC PMC2901032
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Abstract

Background: Clinical trials assessing the impact of errors in self-monitoring of blood glucose (SMBG) on the quality of glycemic control in diabetes are inherently difficult to execute. Consequently, the objectives of this study were to employ realistic computer simulation based on a validated model of the human metabolic system and to provide potentially valuable information about the relationships among SMBG errors, risk for hypoglycemia, glucose variability, and long-term glycemic control. Methods: Sixteen thousand computer simulation trials were conducted using 100 simulated adults with type 1 diabetes. Each simulated subject was used in four simulation experiments aiming to assess the impact of SMBG errors on detection of hypoglycemia (experiment 1), risk for hypoglycemia (experiment 2), glucose variability (experiment 3), and long-term average glucose control, i.e., estimated hemoglobin A1c (HbA1c)(experiment 4). Each experiment was repeated 10 times at each of four increasing levels of SMBG errors: 5, 10, 15, and 20% deviation from the true blood glucose value. Results: When the permitted SMBG error increased from 0 to 5–10% to 15–20%—the current level allowed by International Organization for Standardization 15197—(1) the probability for missing blood glucose readings of 60 mg/dl increased from 0 to 0–1% to 3.5–10%; (2) the incidence of hypoglycemia, defined as reference blood glucose ≤70 mg/dl, changed from 0 to 0–0% to 0.1–5.5%; (3) glucose variability increased as well, as indicated by control variability grid analysis; and (4) the incidence of hypoglycemia increased from 15.0 to 15.2–18.8% to 22–25.6%. When compensating for this increase, glycemic control deteriorated with HbA1c increasing gradually from 7.00 to 7.01–7.12% to 7.26–7.40%. Conclusions: A number of parameters of glycemic control deteriorated substantially with the increase of permitted SMBG errors, as revealed by a series of computer simulations (e.g., in silico) experiments. A threshold effect apparent between 10 and 15% permitted SMBG error for most parameters, except for HbA1c, which appeared to be increasing relatively linearly with increasing SMBG error above 10%.

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  • The probability to measure blood glucose monitoring system results >70 mg/dL with a 'true' glucose concentration of 60 mg/dL increased 10-fold when the allowed range within which 95% of results were found is increased from ±7 mg/dL or ±10% to ±15 mg/dL or ±20%.

    “They found that the probability to measure BGMS results >70 mg/dL (3.88 mmol/L) with a “true” glucose concentration of 60 mg/dL (3.33 mmol/L) increased 10-fold when the allowed range within which 95% of results were found is increased from ±7 mg/dL (0.39 mmol/L) or ±10% (for glucose concentrations <75 mg/dL (4.16 mmol/L) or ≥75 mg/dL (4.16 mmol/L), respectively) to ±15 mg/dL (0.83 mmol/L) or ±20%.”

    From System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015 (2020) · cites this paper as [26]

  • Increasingly inaccurate blood glucose monitoring system results lead to higher glycemic variability when pre-meal and insulin correction boluses were integrated in the model.

    “Furthermore, increasingly inaccurate BGMS results were found to lead to higher glycemic variability when pre-meal and insulin correction boluses were integrated in the model.”

    From System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015 (2020) · cites this paper as [26]

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Authors
Breton, M. D., & Kovatchev, B. P.
Affiliations
University of Virginia (US)
ORCID
Venue
Journal of Diabetes Science and Technology
Publisher
SAGE Publications
Published
2010-05
Volume
4
Issue
3
Pages
562-570
ISSN
1932-2968 (ISSN-L)
DOI
10.1177/193229681000400309
PMC
PMC2901032
OpenAlex
W2124281539
Cited by
103
References
6
Citations by year
2026: 1 · 2025: 4 · 2024: 4 · 2022: 6 · 2021: 6 · 2020: 9 · 2019: 4 · 2018: 13 · 2017: 12 · 2016: 6 · 2015: 12 · 2014: 9 · 2013: 9 · 2012: 4
FWCI
4.12
Type
journal article
Language
en
Open access
Licence
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations
  • Journal of Diabetes Science and Technology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (5r01dk051562-23)
  • National Institute of Diabetes and Digestive and Kidney Diseases (R01DK 51562, R01-DK-051562)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
Keywords
self-monitoring of blood glucose, type 1 diabetes, hypoglycemia risk, glycemic variability, glycemic control, HbA1c, computer simulation, hypoglycemia detection
MeSH terms
Blood Glucose, Computer Simulation, Diabetes Mellitus, Type 1, Humans, Hypoglycemia, Risk Factors, Self Administration, Blood Glucose Self-Monitoring

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