Objective: To compare the results of the glucometer and laboratory techniques for glucose measurement among children.
Study design: Cross-sectional study.
Duration and place of study: 6 months from July 2021 to January 2022, THQ Hospital Dogar, Sadda.
Methodology: 112 children presenting in the outpatient department (OPD) for screening were enrolled in the study after applying the inclusion and exclusion criteria. Blood samples were drawn for measurement of blood glucose both by glucometer and laboratory. The values measured were analysed and diagnostic accuracy was calculated along with correlation between these two techniques.
Results: Out of 112 patients, 47 (42%) were females and 65 (58%) were males. The frequency of diabetes at the screening clinic in our settings came out to be 15.2% (17 patients). The accuracy, sensitivity, and specificity of the glucometer were 84%, 94%, and 82%, respectively. The mean fasting blood sugar measured with a glucometer was 115.37 ± 21.10, and that of the laboratory measured was 97.85 ± 25.55. The mean difference of blood glucose measured with both methods was 17.5 ± 17.05, and t-test analysis showed a significant p value <0.005. A strong correlation (r = 0.7490; p<0.001) was found with glucose measurement with both of these techniques.
Conclusion: Results of the glucometer for the measurement of glucose are highly sensitive and specific. Glucometers can be considered a screening tool for large-scale surveys.

Glucometer, Diabetes, Children, Glucose, Accuracy.

Glucose is the principal compound that is used by the body to produce metabolic energy.[1] The concentration of glucose present in the blood is important because any change in the normal levels can lead to severe metabolic disturbance. Blood glucose level measurement is also pivotal to the diagnosis and management of diabetes mellitus (DM).[1,2]

DM is a metabolic disorder characterized by a state of hyperglycemia in the body that leads to many complications like neuropathy, retinopathy, chronic kidney disease, stroke, ischemic heart disease, etc.[3] Diabetes is one of the most prevalent diseases worldwide. As per recent reports, 463 people are affected by DM.[4] Pakistan has a substantial burden of disease, with reports saying up to 18% prevalence of the disease.[5] This seems to be the tip of the iceberg and goes undiagnosed many times for years. Most of the children with type 1 diabetes remain undetected. There are several reasons for that with the most important being a lack of education, accessibility to tertiary care settings, and laboratory because most of Pakistan’s populations reside in rural areas.[6] So, developing an accurate and easily accessible device for the diagnosis of diabetes remains a challenge to date. Further data on the accuracy of the available devices is also deficient.[7,8]

The monitoring of glucose has been conventionally done using laboratory techniques.[2] This technique is difficult to carry out classical procedures to determine blood glucose in the laboratory when it comes to frequent measurement of blood glucose levels required for continuous regulation and management of the disease. It is because they require large volumes and are time-consuming.[9,10] Glucometer is a device that can be used for fast checking of glucose values in the blood in a normal routine.[10] It requires a small sample of blood volume and minimal technical expertise, and it gives a result in seconds.[11] However, the extent to which the results obtained by glucometers are accurate when it comes to the diagnosis of DM. There are not enough studies that provide enough evidence about its usefulness or uselessness. This study aims to determine the usefulness of a glucometer in the determination of blood glucose levels for the diagnosis of DM in children.

It was a cross-sectional study conducted at THQ Hospital Dogar, Sadda, for a duration of 6 months from July 2021 to January 2022. Ethical approval for the study was granted by the hospital ethical board of THQ Hospital Dogar. After getting permission from the institutional review board, a sample size of 112 was collected through non-probability consecutive sampling. All the children of both genders attending OPD at Khyber teaching hospital who were previously not screened for diabetes were included in the study, while those who were known diabetics or were using corticosteroids or had any history of seizures that might result in disturbed glucose metabolism were excluded from the study.

Informed consent from the guardian was obtained after the inclusion of the patient as per the criteria. For glucometer measurement, a single prick was given on the tip of the finger or the heel to get a single drop of capillary blood. For laboratory measurement, two ml of venous blood was taken in a syringe. Glucometer (model: Easy Gluco Model IGM-0016B Osang Healthcare Co. Ltd) was used. Another sample was sent to a laboratory and was assessed with the machine name Micro Lab 300. Fasting glucose level of greater than 125 was considered to indicate diabetes.[12] All the data collected were analysed using statistical package for the social sciences (SPSS) 23.0.

A total of 112 paired blood samples from the children visiting the screening of the endocrinology clinic were obtained. The mean age of the patient was 13.72 ± 17.29 months (minimum 3 days; maximum 8 years). Out of 112 children, 47 (42%) were females and 65 (58%) were males, with a female-to-male ratio of 1:1.38. Diabetes was present in 17 (15.2%) patients, and the rest of the other 95 (84.8%) were non-diabetic, considering laboratory values as a gold standard. Of these 17 diabetics, 16 were truly diagnosed with a glucometer, and only one patient had a false negative. Whereas 78 (69.6%) non-diabetics were picked as true negatives by a glucometer, and 17 patients had spuriously high readings and came out to be false positives using a glucometer. The cumulative accuracy, sensitivity, and specificity of the glucometer came out to be 84%, 94%, and 82%, respectively.

Table 1: Gender distribution, diabetes status, and accuracy of the glucometer

The mean fasting blood sugar measured with a glucometer was 115.37 ± 21.10, and that of the laboratory measured was 97.85 ± 25.55. The mean difference between these two was 17.5 with a standard deviation of 17.05. The t-test analysis showed a significant p value of <0.005, which signifies that these two groups are considerably different, and glucometers should not be considered as a standard of diagnosis and cannot replace laboratory techniques.

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition. In this condition, the pancreas makes little or no insulin. Insulin is a hormone the body uses to allow sugar (glucose) to enter cells to produce energy. Different factors, such as genetics and some viruses, may cause type 1 diabetes. Although type 1 diabetes usually appears during childhood or adolescence, it can develop in adults.[13]

Even after a lot of research, type 1 diabetes has no cure. Treatment is directed toward managing the amount of sugar in the blood using insulin, diet, and lifestyle to prevent complications. The children are later diagnosed with diabetes, often with its complications like diabetic ketoacidosis (DKA), etc. This demands screening of children on a mass level. However, most of the population resides in rural areas, and accessibility and affordability of laboratories remain neglected issues. An accurate, fast, and readily available is the need of the hour. We compared the accuracy of a readily available glucometer in our study.

In our study, the average mean of glucose as measured by glucometer (115.37 ± 21.10) was higher than that of laboratory values (97.85 ± 25.55). This depicts that the glucometer measures a bit higher value than the actual value. This has been supported by many experimental and clinical studies. The means of both groups were different, and a p-value of <0.05 proved the difference in values between the two groups. This is also consistent with previous studies.[14,15] We found 94% sensitivity and 82% specificity along with an accuracy of 84 %. There was only a single case of diabetes that was false-negative and may be an error missed by a glucometer; occasionally, they may be incorrect. A low probability of missing the diagnosis was found. This implies that this glucometer is highly sensitive but is moderately specific. The literature agrees with it, keeping in view a slight change of values with changing quality of different glucometers.[16-18] This has been studied by another recent study which showed an accuracy, specificity, and sensitivity of 79.10%, 78.24, and 96.97% respectively.[18]

In our study, a strong correlation was found with both measurements of glucose (r = 0.749). This conveys the fact that both groups have a strong linear association with each other, as reported by several other studies (r = 0.98; p<0.001, 0.96; p<0.001).[18] However, some studies are contradictory to our results. They have shown a weak relationship between glucose measurement by a glucometer and standardized laboratory techniques.[2,15]

There are certainly a few limitations to the study. It was a single-centered study with a limited sample size. We used a single type of glucometer and included people from the same ethnicity. A large multicenter study comparing the analytical performance of various glucometers and laboratory techniques is recommended for the future.

Our study showed the glucometer to be highly sensitive. But it was not that accurate and specific to use as a reliable source. However, screening can be performed with it at the mass level, and conflicting values can further be confirmed by laboratory or other techniques. Moreover, developing more accurate devices to add to the reliability for screening and conducting large studies with different types of glucometers is recommended.

Not reported

Not reported

Corresponding Author:
Hamid Iqbal Bangash
Department of Pediatrics
Health Department Peshawar, Pakistan
Email: hamidbangash2000@gmail.com

Co-Authors:
Mohammad Kashif
Department of Pediatrics
Pediatric MTI Khyber Teaching Hospital Peshawar, Pakistan

Yusra Hamid
Department of Pediatrics
Frontier Medical College, Abbottabad, Pakistan

Tahir Hayat
Department of Pediatrics
Children Specialist, Khyber Pakhtunkhwa, Pakistan

Bilal
Department of Pediatrics
Pediatrician, THQ Hospital Dogger, Sadda, Pakistan

All authors contributed to the conceptualization, investigation, and data curation by acquiring and critically reviewing the selected articles. They were collectively involved in the writing – original draft preparation, and writing – review & editing to refine the manuscript. Additionally, all authors participated in the supervision of the work, ensuring accuracy and completeness. The final manuscript was approved by all named authors for submission to the journal.

Ethical approval for the study was granted by the hospital ethical board of THQ Hospital Dogar. Data was collected after taking written consent from the parents of the enrolled children in our study.

The author declares no conflict of interest in the study.

None

https://doi.org/10.63096/medtigo30622411

Iqbal HB, Kashif M, Hamid Y, Hayat T, Bilal. Comparison of results of glucometer and laboratory technique for glucose measurement among children. medtigo J Med. 2024;2(4):e30622411. doi:10. 63096/medtigo30622411 Crossref