Abstract
Management of diabetes mellitus requires self-monitoring of blood glucose (SMBG) levels by patients, 1 and glucose meters are widely used for this. Despite consistently obtaining “normal” blood glucose levels on their meters, some patients with diabetes may develop complications. 2 This raises the question of functionality of the meters which should give aberrant results if quality measures are suboptimal. Periodic checks using quality control (QC) solutions are important to determine functionality. 3 We aimed to determine the functionality of glucose meters used by patients with diabetes for SMBG using QC solutions.
A descriptive, cross-sectional design was used. Ethics approval and informed consent from the patients were obtained. Adult patients with diabetes, who used glucose meters for SMBG attending diabetic clinic at the University of Nigeria Teaching Hospital, Enugu, were recruited. Questionnaires were administered to obtain demographic and clinical information, then manufacturer-specific QC solutions were applied to the meters in duplicate to obtain readings. The readings were compared with the target range to determine functionality of the meter at that level. No blood sample was tested.
In total, 108 meters of six different brands were evaluated. The readings from the meters and their status of functionality are given in Table 1. Meter 1 had the best functionality −97% for low readings and 92% for high readings, given the number of meters tested. Although meters 4 and 5 had 100% functionality status, their numbers were few. Meter 6 had the worst functionality at both QC levels, but only two meters were evaluated. None of the patients had prior knowledge about the use of QC solutions to periodically check their glucose meters. Errors observed in 22 meters were: expired strips—8, battery problem—5, chip code error—5, and expired QC solution—4. For these errors, replacements were made with those from the researcher in order to obtain a reading from the meter.
Glucose Readings from Patients’ Glucose Meters (n = 108) Using Quality Control Solution, and Their Status of Functionality.
Determined by number of readings that fell within the expected QC solution target range as per the manufacturers’ insert.
Most of the meters were determined to be functional, but for those that were nonfunctional and had two QC levels, it was the high level that had more nonfunctional status. This would mean that the affected meters would properly detect a hypoglycemic specimen but not a hyperglycemic one. It is advantageous to perform QC checks at both low and high glucose levels to ascertain that the meter will function properly to a hypoglycemic or hyperglycemic specimen. Hyperglycemic emergencies are a major cause of concern among diabetic admissions, 4 and it is also important to detect hypoglycemia especially in patients on insulin therapy. 5 Therefore, glucose meter manufacturers should produce two QC levels, unlike the single (normal) level that was seen in some cases. Some meters did not come with QC solutions in their packs, but even for those present, the patients did not know what it was for or how to use it—similar to findings by Chaudhry and Klonoff. 6
Patients should be taught to check their glucose meters periodically for functionality as part of their management. Glucose meter manufacturers and vendors should provide QC solutions with each new meter as well as instructions for use.
Footnotes
Abbreviations
QC, quality control; SMBG, self-monitoring of blood glucose.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
