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Application of two-phase statistical process control to detect glycemic instability in critically ill patients
Mohamed Metwally Mosly1,2, Hesham Metwalli3, Hesham Mousli4,1,2
1Department of Pharmacy Practice, Arab Academy for Science Technology and Maritime Transport, Alexandria, Egypt.
International Journal of Health Care Quality Assurance
|July 14, 2026
Summary
Statistical process control (SPC) identified significant ICU Day-2 glycemic instability in 50.5% of patients. Higher illness severity and certain clinical factors predicted instability, suggesting a need for data-driven quality improvement.
Area of Science:
- Critical Care Medicine
- Health Services Research
- Clinical Chemistry
Background:
- Glycemic control in intensive care units (ICUs) is crucial for patient outcomes.
- Day-2 glycemic performance monitoring is essential for identifying process variations.
- Statistical Process Control (SPC) offers a framework for monitoring and improving healthcare processes.
Purpose of the Study:
- To implement a two-phase SPC framework for monitoring ICU Day-2 glycemic control.
- To detect glycemic instability using SPC criteria.
- To identify clinical predictors of out-of-control Day-2 glycemic patterns in an Egyptian tertiary ICU.
Main Methods:
- A prospective observational cohort study involving 1,300 adult ICU patients.
- Phase I: Established empirical SPC control limits using 300 patients' Day-2 glucose data.
- Phase II: Applied fixed limits to 1,000 patients, using Nelson Rules 1 and 2 for instability detection and logistic regression for predictor analysis.
Main Results:
- Over 50% (50.5%) of patient subgroups in Phase II signaled "out-of-control" glycemic status.
- Rule 1 (excursions) and Rule 2 (shifts) identified significant glycemic variability.
- Predictors of instability included higher illness severity (APACHE II), sepsis, older age, higher HbA1c, vasopressor/corticosteroid use, and comorbidities; higher caloric intake was protective.
Conclusions:
- A combined SPC and regression approach effectively monitors ICU Day-2 glycemic instability.
- This framework can support targeted, data-driven quality improvement initiatives.
- Further interventional studies are needed to confirm the impact of SPC-guided glycemic management on clinical outcomes.
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