HbA1c Test Research Articles

Glycated Hemoglobin as a Screening Tool in the Diagnosis of Diabetes Mellitus among Adult Patients in a Tertiary Health Facility in Port Harcourt, Niger Delta Region of Nigeria

Abstract Background: The prevalence of diabetes mellitus (DM) has been increasing worldwide, especially in Nigeria. However, it remains underdiagnosed in many people with the disease. There is a need for early detection and treatment of the populations that are at risk to prevent or reduce complications. There is a paucity of Nigerian studies documenting the performance of the glycated hemoglobin (HbA1c) test in diagnosing DM. This, therefore, informed our decision to embark on this study. Objective: The objective of this study was to assess the role of the HbA1c in the diagnosis of DM at the University of Port Harcourt Teaching Hospital. Materials and Methods: This was a descriptive cross-sectional study, in which 400 subjects were evaluated for the presence of glucose intolerance. Two hundred patients with hypertension and 200 nonhypertensives patients were screened for DM. A structured questionnaire was administered to the recruited subjects, and their blood samples were collected for HbA1c and fasting plasma glucose. The detection of DM using the two different screening tests was determined. The sensitivity and specificity were calculated. Results: The mean age of the hypertensive subjects was 48 ± 10 years, whereas that of the nonhypertensive subjects was 46 ± 10 years. The frequency of diabetes in the study population by the HbA1c was 7.8%, whereas it was 25.3% by the oral glucose tolerance test (OGTT) (P < 0.001). The frequency of prediabetes was 25.3% by the HbA1c as compared to 20.5% by the OGTT (P < 0.001). The sensitivity of the HbA1c test for the diagnosis of diabetes was 62.5%, whereas the specificity was 99.7%. Conclusions: This study shows that there was a significant difference in the diagnostic performance of the HbA1c test compared to the OGTT; HbA1c test was less accurate and more likely to miss some diagnoses.

Regular HbA1c examination and health outcomes in adult patients with type 2 diabetes in South Korea: A retrospective cohort study.

Concerns have been raised about the effectiveness of using process-centered indicators to assess the quality of diabetes care in Korea. This study aims to examine the factors influencing the performance of regular HbA1c testing and to explore its association with health outcomes, including hospitalization and mortality. We utilized a retrospective cohort design with a 4-year follow-up period, involving 159,452 adult patients newly diagnosed with type 2 diabetes (E11 in International Classification of Diseases, 10th Edition) in 2011. We established a national population database by merging the Korea National Health Insurance (KNHI) claims database and the KNHI Qualification Database of South Korea. The proportion of diabetic patients who underwent regular HbA1c testing at least once a year in the first 3 years was determined to be 33.8%. In comparison, patients who did not receive regular tests during the same period exhibited significantly increased odds of hospitalization (diabetes/CVD/renal, OR, 1.23, 95% CI, 1.12-1.34; diabetes, OR, 1.36, 95% CI, 1.17-1.57). Additionally, this nonpatient group experienced a higher risk of mortality (OR: 1.56, 95% CI: 1.36-1.80). This study supports the positive impact of regular HbA1c testing on health outcomes for individuals with type 2 diabetes. To increase the current 33% rate of regular HbA1c testing, developing patient-customized management policies is essential. Priority should be given to diabetic patients aged 65 or older, living in rural areas, and those belonging to low-income families (medical aid).

Performance evaluation of the glycated hemoglobin A1c analyzer for point-of-care testing compared with laboratory-based devices: a multicenter validation study

In this dual-center study, we assessed the BioHermes A1C EXP M13 system for point-of-care (POC) HbA1c testing against two NGSP-certified HPLC instruments, the Bio-Rad D100 and Tosoh G8. Analyzing 605 samples, we evaluated the A1C EXP's reproducibility, sensitivity, specificity and impact of anemia on HbA1c measurements. The device showed excellent reproducibility with CVs under 2.4% and high sensitivity and specificity for diabetes diagnosis—98.1% and 96.8% against D100, and 97.1% and 96.7% against G8. Passing-Bablok regression confirmed a close correlation between A1C EXP and the HPLC instruments, with equations y = 0.10625 + 0.9688x (D100) and y = 0.0000 + 0.1000x (G8), and Bland–Altman plots indicated mean relative differences of −1.4% (D100) and −0.4% (G8). However, in anemic samples, A1C EXP showed a negative bias compared to HPLC devices, suggesting that anemia may affect the accuracy of HbA1c results. The study indicates that A1C EXP is a reliable POC alternative to laboratory assays, albeit with considerations for anemic patients.

Interference in HbA1c measurement: a case of electropherogram shift due to hyperleukocytosis leading to the discovery of leukemic mantle cell lymphoma

HbA1c is a pivotal biomarker in diabetes management, reflecting long-term glycaemic control. HbA1c is often measured with capillary electrophoresis, which generally is a very precise technique, but there can be interference, especially in the case of haemoglobin diseases. Thus, in patients with underlying conditions, the accurate measurement of HbA1c can be challenging. We present a case of special interference in a 74-year-old female patient referred to a HbA1c test, in whom the measurement was thought to be significantly affected by hyperleukocytosis and led to an unexpected diagnosis of leukemic low-grade lymphoma. This case report highlights the underrecognized potential interference of leukocytosis in HbA1c measurement. It underscores the importance of clinical vigilance when interpreting HbA1c results in patients with underlying haematological conditions.

Impact of Point of Care Hemoglobin A1c Testing on Time to Therapeutic Intervention.

Without compromising accuracy, point of care testing (POCT) provides immediate results at the time of in person patient consultation. The purpose of this study was to evaluate time until therapeutic intervention with POCT HbA1c versus venipuncture, where venipuncture was considered standard of care.The primary outcome was time (hours) to implementation of a therapeutic intervention based on POCT HbA1c result, as compared with most recent venipuncture HbA1c before the study and its associated therapeutic intervention. A total of 94 POCT HbA1c tests were included in the primary analysis.For the POCT HbA1c, the mean time to therapeutic intervention was 1.6 ± 3.14 hours. For the previous venipuncture HbA1c, the mean time to therapeutic intervention was 1376.66 ± 3356.6 hours (P < .001). Overall, this trial showed that POCT HbA1c results in a significantly faster time to therapeutic intervention than venipuncture in a primary care clinic that serves a rural population.

Prediabetes : Prevalence and Causes

Prediabetes is a condition where the blood glucose levels are high, but not enough to be diagnosed as diabetes. The HbA1C test can identify the prediabetes conditions as the blood glucose levels are between 5.7% to 6.4%. The fasting glucose level are said to be around 125 mg/dL and IGT levels are seen around 199 mg/dL. Prediabetes have a high burden of Cardiovascular Risk. Prediabetes is a multifactorial condition, the environmental risk factors include diet, lack of physical activity, increase age, obesity or overweight and the biological risk factors include insulin resistance, genetic disposition and beta cell dysfunction. According to research carried out in 2021, the global prevalence is said to be around 14%, combining the prevalence of IGT and IFG. Awareness of Prediabetes is very much needed because an affected individual, if not aware, may end up in a severe disease such as CVD.

Predictors of readmission and mortality in adults with diabetes or stress hyperglycemia after initial hospitalization for COVID-19

IntroductionWe previously reported predictors of mortality in 1786 adults with diabetes or stress hyperglycemia (glucose>180 mg/dL twice in 24 hours) admitted with COVID-19 from March 2020 to February 2021 to...

Primary care monitoring of HbA1c tests in type 2 diabetic patients in Northern France and impact of the successive COVID-19 pandemic containments

BackgroundFrench health authorities recommend the testing of HbA1c every 3 to 6 months in patients with diabetes. The successive containments linked to the SARSCoV-2 pandemic may have had a profound impact on the follow-up of diabetic patients in primary care. The objective of this study was to investigate the effect of containments on the volume of HbA1c assays and on HbA1c values of type 2 diabetic patients monitored in primary care in Northern France compared to usual seasonal variations. MethodsEpidemiological study of a multicentre retrospective cohort, collecting the number and the value of HbA1c assays from type 2 diabetic patients, carried out in 73 private medical analysis laboratories in Northern France region between October 1, 2018 and October 31, 2022. ResultsA total of 196,744 patients and 828,037 tests were included. The first and third containments were associated with a significant decrease in the mean number of performed HbA1c tests, the decrease in the 2nd containment did not reach significance. We observed a significant decrease in HbA1c testing during the winter holiday season and the summer months. The variations in HbA1c values were not substantial compared to seasonal variations.

Lower achievement of guideline recommended care in Canadian adults with early-onset diabetes: A population-based cohort study

AimsAdults with early-onset diabetes (age < 40 years) have an increased risk of complications, and it is unclear whether they are receiving guideline recommended care. We compared the frequency and results of haemoglobin A1c (HbA1c) testing in adults with early-onset and usual-onset diabetes and assessed factors related to guideline concordance. MethodsPopulation-level databases from Alberta, Canada (∼4.5 million) were used to identify adults with incident diabetes. The cohort was stratified by age at diagnosis (< 40 vs. ≥ 40 years) and then followed for 365 days for HbA1c testing. Adjusted multivariable analyses were used to identify clinical and sociodemographic factors associated with guideline concordance. ResultsAmong 23,643 adults with incident diabetes (mean age 54.1 ± 15.4 years; 42.1 % female), 18.9 % had early-onset diabetes. Early-onset diabetes was associated with lower frequency of testing (adjusted odds ratio (aOR), 0.80; 95 % CI 0.70–0.90) and above target glycaemic levels compared to usual-onset diabetes (aOR, 1.45; 95 % CI 1.29–1.64). Factors associated with guideline concordant frequency of HbA1c testing were rural residence and insulin use. ConclusionsIn our universal care setting with premium-free health care, early-onset diabetes was associated with lower rates of HbA1c testing and sub-optimal glycaemic control compared to those with usual-onset diabetes.

Patient result monitoring of HbA1c shows small seasonal variations and steady decrease over more than 10 years.

Internal and external quality assurance materials often use highly processed matrixes. This can render the materials non-commutable. Monitoring laboratory methods with patient medians helps in identifying and correcting systematic errors that may affect diagnostic accuracy. The aim of the present study was to use HbA1c patient results for monitoring of method performance over time. Test HbA1c results from 2010 to 2022 was analyzed (n=722,553) regarding changes over time and seasonal variation. The HbA1c testing was initially performed on a Cobas 501 instrument using immunological detection but in May 2017 the method was replaced by capillary electrophoresis on Capillarys 3 Tera. There was a steady decrease in HbA1c values. From 2011 to 2021 the decrease was for 0.10 percentile 6.6 %, lower quartile 7.9 %, median 10.2 %, mean values 9 %, upper quartile 11.2 %, and 0.90 percentile 9.3 %. No clear shift in HbA1c levels was observed due to the shift in methods. The median HbA1c values per month was approximately 44 mmol/mol (6.2 %, DCCT/NGSP). The only month with a median HbA1c that differed by more than 1 mmol/mol was July with a median value of 42 mmol/mol (6.0 %). The patient data showed a similar decrease as in the National Diabetes Register which indicates that the method is stable over time without any sudden changes and that the seasonal variation is low. The continuous decrease in HbA1c values over time is most likely to a shift towards earlier detection of patient with diabetes and improved treatment.

Real-world clinical validation of the Qatar pre-diabetes risk score: a cross-sectional study

IntroductionPre-diabetes stands as a prominent, independent risk factor for the onset of type 2 diabetes (T2D), with 5%–10% of individuals with pre-diabetes progressing to T2D annually. The effectiveness of rigorous...

Determinants of sub-optimal glycemic control among patients enrolled in a medicine dispensing programme in KwaZulu-Natal: A cohort study, 2018-2021.

The Central Chronic Medicines Dispensing and Distribution (CCMDD) programme facilitates clinically stable patients to collect their chronic medication from community-based pick-up points. We determined baseline glycaemic control and rates and predictors of becoming sub-optimally controlled for type 2 diabetes mellitus (T2DM) CCMDD-enrolled patients. The setting of the study was eThekwini, KwaZulu-Natal, South Africa. We performed a cohort study (April 2018- December 2021). We linked T2DM CCMDD-enrolled patients to glycated haemoglobin (HbA1c) data from the National Health Laboratory Service. We selected patients optimally controlled at their baseline HbA1c, with ≥ 1 repeat-test available. We used Kaplan-Meier analysis to assess survival rates and extended Cox regression to determine associations between time to sub-optimal control (HbA1c 7%) and predictors. Adjusted hazard ratios (aHRs), 95% confidence interval (CI), andp-values are reported. Of the 41145 T2DM patients enrolled in the CCMDD programme, 7960 (19%) had a HbA1c result available. Twenty-seven percent (2147/7960) were optimally controlled at their baseline HbA1c. Of those controlled at baseline, 695 (32%) patients had a repeat test available, with 35% (242/695) changing to sub-optimal status. The HbA1c testing frequency as per national guidelines was associated with a lower hazard of sub-optimal glycaemic control (aHR: 0.46; 95% CI: 0.24-0.91;p-value = 0.024). Patients prescribed dual-therapy had a higher hazard of sub-optimal glycaemic control (aHR: 1.50; 95% CI: 1.16-1.95;p-value = 0.002) versus monotherapy. The HbA1c monitoring, in-line with testing frequency guidelines, is needed to alert the CCMDD programme of patients who become ineligible for enrolment. Patients receiving dual-therapy require special consideration.Contribution:Addressing identified shortfalls can assist programme implementation.

Association of H. pylori IgG and CagA-IgG with some immunological and biochemical parameters in diabetic patients.

Helicobacter pylori a gram-negative, microaerophilic, spiral-shaped, and flagellated bacteria whose primary reservoir is the human stomach. It can cause gastric and extra-gastric diseases. So the study aimed to find the relationship between infection with H. pylori and progression of type II diabetes with other immunological markers. Method This study was conducted in Kirkuk City from Nov. 2022 to Apr. 2023 and included 106 individuals, 26 as a control group and 80 patients (34 males and 46 females) with mean age 57.61 suffering from DMII with H. pylori stool antigen positive results (immunochromatographic test cassette). Five ml of venous blood samples were taken for the HbA1c test (immunodetection technique), fast serum glucose (Hexokinase/G-6-PDH), serum H. pylori IgG, H. pylori CagA IgG, Interlukin-1?, and Interleukin-10 analysis (Sandwich-ELISA technique). Results There was a positive correlation between H. pylori IgG titer and HbA1c levels (0.0321, P = 0.004). In addition, there was a positive correlation between the levels of IL-1? and the H. pylori CagA IgG (r =0.579, P = 0.000). While a negative correlation was found between HbA1c level and IL-10 concentration, (r = -0.500, P = 0.000), there was also a negative association between IL-1? and IL-10 concentrations (r = -0.485, P = 0.000). Conclusion: Through the results of this correlation, we suggest a relationship between H. pylori infection and DMII.

Implementing HbA1c monitoring in sub-Saharan Africa: Lessons learnt from a pilot project in Mozambique

AimsWe aimed to evaluate lesson learnt from a pilot project in Mozambique focused on point-of-care (POC) HbA1c testing for diabetes management in primary health care facilities. MethodsOver a three-year period, several health centers were equipped with POC HbA1c testing machines. The evaluation involved 12 months of data collection, interviews with patients and staff, and regular supervision visits. ResultsThe project screened over 22,000 individuals and provided HbA1c testing to 2362 diabetes patients. Among the analyzed results, 65.7 % had HbA1c levels below 7 %, 10.9 % between 7 % and 8.5 %, and 23.4 % above 8.5 %. POC testing showed advantages such as reduced costs and improved workload management. ConclusionsLimited access to HbA1c testing remains a challenge in African countries. The pilot project demonstrated the feasibility of POC HbA1c testing and highlighted the need for increased efforts to make it more widely available, leading to improved diabetes management and patient outcomes.

Effect of COVID-19 lockdown on glycated haemoglobin testing and utilisation in KwaZulu-Natal, South Africa.

Diabetic monitoring and treatment guidelines are easily accessible, but compliance is poor in KwaZulu-Natal. The coronavirus disease 2019 (COVID-19) pandemic had a devastating impact on diabetic healthcare, both directly and through public health interventions. This study aimed to close the gaps in knowledge concerning glycated haemoglobin (HbA1c) test utilisation and how this was affected by the COVID-19 lockdown in KwaZulu-Natal. We reviewed HbA1c test volumes and results from public health facilities in the 11 health districts in KwaZulu-Natal, South Africa. We compared testing trends and glycaemic control between two 10-month study periods before (March 2019 - December 2019) and during (March 2020 - December 2020) the COVID-19 pandemic. The number of HbA1c tests performed decreased 6.1% during the pandemic period, with 173 760 HbA1c tests performed in 2019 and 163 236 HbA1c tests performed in 2020. There was a statistically significant increase in the average HbA1c level during the pandemic (mean HbA1c level in the pre-pandemic period: 70.5 mmol/mol [8.6%] versus mean HbA1c level in the pandemic period: 72.7 mmol/mol [8.8%]; p-value < 0.001). Of patients with suboptimal HbA1c results (83 421 in 2019, 83 259 in 2020), 11 656 (14.0%) in 2019 and 10 086 (12.1%) in 2020 had more than one HbA1c test performed during the study period. The COVID-19 pandemic impacted glycaemic monitoring in KwaZulu-Natal with lower HbA1c test volumes and worse glycaemic control seen during the pandemic. HbA1c testing practices are not in keeping with recommended guidelines. The study demonstrates that the COVID-19 pandemic impacted HbA1c utilisation in KwaZulu-Natal. Importantly, HbA1c testing practices in KwaZulu-Natal are not in keeping with Society for Endocrinology, Metabolism and Diabetes of South Africa guidelines regarding the monitoring of diabetic patients, and this requires more attention for future diabetic healthcare interventions.

Prevalence of Obesity with its Associated Modifiable Risk Factors among Adolescents of Aged 17-24 Years: Cross-Sectional Study

Objective: This study aims to point out the association of modifiable risk factors and the prevalence and riskfactors of overweight and obesity among adolescents aged 17-24 years.Study Design: Cross-sectional descriptive study.Place and Duration of Study: The study was conducted at the Department of Community Medicine, CombinedMilitary Hospital (CMH) College Lahore, Pakistan from April 2022 to May 2022.Methods: A cross-sectional study was performed on a sample size of 108 adult males through nonprobabilityconvenient sampling in CMH Lahore Medical College, Lahore, Pakistan. HbA1c tests were conducted to checkblood sugar. A questionnaire was distributed to collect data. SPSS software was used for the analysis of datausing the Chi-square test.Results: A total of 108 male cadets participated in the study. Mean age was 20.20 years ±1.4 SD. The majority ofparticipants were involved in physical activity and had healthy eating habits. Eighty-nine percent ofrespondents fall in the category of normal body mass index &amp; 6.5% in the category of overweight &amp; obese &amp; 3.7% were underweight. Forty-seven percent of subjects were physically active for ≤ 3 days/week &amp; 57.4% wereengaged for &gt; 3 days/week. Fifty-seven percent of respondents had a screen time of 5-7 hours/day &amp; 11.1% has&gt; 7 hours/day. Among 108 respondents, 37% had snacking habits in between meals 1-2 times/week &amp; 20.4%has 3-4 times/week.Conclusion: This study concludes that apart from non-modifiable risk factors, modifiable risk factors also have a major influence on the prevalence of overweight &amp; obesity. Those who exercise &amp; eat healthy have less risk ofdeveloping obesity as compared to those who have poor physical activity &amp; unhealthy eating habits. How to cite this: Zaib S, Raza T, Ahmad A, Anwar S, Tariq SMH, Mubashar T. Prevalence of Obesity with its Associated Modifiable Risk Factors Among Adolescents of Aged 17-24 Years: Cross Sectional Study. Life and Science. 2024; 5(2): 210-215. doi: http://doi.org/10.37185/LnS.1.1.362

HbA1c as an early diagnostic marker in gestational diabetes mellitus.

Objective: To assess the effectiveness of HbA1c as an indicator of Gestational Diabetes mellitus(GDM). Study Design: Prospective Cases Control study. Setting: Fauji Foundation Hospital Rawalpindi. Period: March 2022 to Oct 2022. Methods: All pregnant females older than 18 years of age having pregnancy confirmed by gynecologist in 1st trimester were included. A 5ml blood sample was obtained from each case to evelaute the HbA1c level. Oral glucose tolerance test (OGTT) was performed on both groups at conception to 12 weeks (1st trimester) as well as at 12 to 24 weeks of gestation (2nd trimester) to evaluate correlation between OGTT and HbA1c test. All the females suffering from GDM were taken in cases group and comparatively in equal number non GDM pregnant women were taken in control group. All the relevant information was collected via study proforma and SPSS version 26 was used for analysis. Results: The number of females suffering from GDM was 45 in number and we took 45 pregnant females as control group. Average level of HbA1c in women with GDM (test group) was higher than in women with Non-GDM (control group). Patients having age groups 35-39 showing greater prevalence of gestational diabetes with 73.2% sensitivity and 66.7% specificity at a cut-off value of 5.6% (31 mmol/mol) for GDM diagnosis. Conclusion: The findings reveal significantly elevated HbA1c levels during both the first and second trimesters in individuals diagnosed with GDM, with a test specificity of 95%. This underscores its ability to accurately pinpoint individuals who truly have GDM. However, HbA1c is observed as a valuable diagnostic tool for the early detection of GDM.

Comparison between a new point-of-care HbA1c test and a routine laboratory method

Comparison between a new point-of-care HbA1c test and a routine laboratory method

Implementation of HbA1c testing at point of care improves patients health-driven testing adherence and reported outcomes

Implementation of HbA1c testing at point of care improves patients health-driven testing adherence and reported outcomes

Deploy the HBA1C test results auto-verification middleware to create laboratory value in DM patient management in a regional hospital

Deploy the HBA1C test results auto-verification middleware to create laboratory value in DM patient management in a regional hospital