A1c Testing Research Articles

The borderline effect for diabetes: when no difference makes a difference.

We hypothesized that people at the borderline of being labeled as "prediabetic" based on A1c blood test results, who initially face equivalent risks of developing diabetes but who are labeled differently, would be more likely to develop diabetes when labeled as "prediabetic" as a result of the label. Study 1 served to establish the psychological effect of the prediabetes label: we surveyed 260 participants on Amazon Mechanical Turk to test whether risk perception significantly increased when comparing A1c test results that differed by 0.1% and led to different diagnostic labels (5.6 and 5.7%) but did not significantly increase when comparing those that differed by 0.1% but received the same label (5.5%/5.6 and 5.7%/5.8%). Study 2 explored whether labels are associated with different rates of developing diabetes when the initial difference in A1c results suggests equivalent risk. Using data from 8,096 patients, we compared patients whose initial A1c results differed by 0.1% and found those who received results labeled as prediabetic (A1c of 5.7%) were significantly more likely to develop diabetes than patients whose initial results were labeled as normal (5.6%). In contrast, patients whose initial results differed by 0.1% but who received the same "normal" label (5.5 and 5.6%) were equally likely to develop diabetes. These preliminary results suggest that diagnostic labels may become self-fulfilling, especially when the underlying pathology of patients receiving different labels does not meaningfully differ.

Implementation of A1C testing at point of care: Is it good enough for clinical practice?

Implementation of A1C testing at point of care: Is it good enough for clinical practice?

FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes

ObjectiveThe purpose of this study was to test the preliminary effectiveness of a cognitive behavioral therapy intervention (Fear Reduction Efficacy Evaluation [FREE]) designed to reduce fear of hypoglycemia in young adults with type 1 diabetes. The primary outcome was fear of hypoglycemia, secondary outcomes were A1C, and glycemic variability. MethodsA randomized clinical trial was used to test an 8-week intervention (FREE) compared to an attention control (diabetes education) in 50 young adults with type 1 diabetes who experienced fear of hypoglycemia at baseline. All participants wore a continuous glucose monitor for the 8-week study period. Self-reported fear of hypoglycemia point-of-care A1C testing, continuous glucose monitor-derived glucose variability were measured at baseline, Week 8, and Week 12 (post-program). ResultsCompared to controls, those participating in the FREE intervention experienced a reduction in fear of hypoglycemia (SMD B = −8.52, p = 0.021), change in A1C (SMD B = 0.04, p = 0.841) and glycemic variability (glucose standard deviation SMD B = −2.5, p = 0.545) by the end of the intervention. This represented an 8.52% greater reduction in fear of hypoglycemia. ConclusionA cognitive behavioral therapy intervention (FREE) resulted in improvements in fear of hypoglycemia.Clinicaltrials.govNCT03549104

Are Guideline-concordant Processes of Care Consistent Across the Rural–Urban Continuum? A Retrospective Cohort Study of Adults Newly Treated for Type 2 Diabetes

ObjectivesOur aim in this study was to identify the association between place of residence (metropolitan, urban, rural) and guideline-concordant processes of care in the first year of type 2 diabetes management. MethodsWe conducted a retrospective cohort study of new metformin users between April 2015 and March 2020 in Alberta, Canada. Outcomes were identified as guideline-concordant processes of care through the review of clinical practice guidelines and published literature. Using multivariable logistic regression, the following outcomes were examined by place of residence: dispensation of a statin, angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), eye examination, glycated hemoglobin (A1C), cholesterol, and kidney function testing. ResultsOf 60,222 new metformin users, 67% resided in a metropolitan area, 10% in an urban area, and 23% in a rural area. After confounder adjustment, rural residents were less likely to have a statin dispensed (adjusted odds ratio [aOR] 0.83, 95% confidence interval [CI] 0.79 to 0.87) or undergo cholesterol testing (aOR 0.86, 95% CI 0.83 to 0.90) when compared with metropolitan residents. In contrast, rural residents were more likely to receive A1C and kidney function testing (aOR 1.14, 95% CI 1.08 to 1.21 and aOR 1.17, 95% CI 1.11 to 1.24, respectively). ACEi/ARB use and eye examinations were similar across place of residence. ConclusionsProcesses of care varied by place of residence. Limited cholesterol management in rural areas is concerning because this may lead to increased cardiovascular outcomes.

Adverse childhood event subtypes and routine diabetes care utilization among U.S. adults with Type 2 diabetes.

Adverse childhood events (ACEs) have significant impacts on adulthood health, including greater risk of Type 2 diabetes (T2D). While there is a known connection to increased use of outpatient and emergency healthcare services, the potential role of ACEs in routine diabetes care utilization remains unclear. This study uses ACE subtypes to explain pathways to routine diabetes care utilization among adults with T2D. Cross-sectional data were obtained from the 2019 Behavioral Risk Factor Surveillance System, a survey of a representative sample of U.S. adults. Eligible participants resided in a state that completed both the Adverse Childhood Experiences (ACEs) and Diabetes modules and were diagnosed with non-gestational diabetes (N = 9,904), of whom the majority were presumed to have T2D. Confirmatory factor analysis was used to test the measurement model for three ACE factors: household dysfunction, physical and emotional abuse, and sexual abuse. Structural equation modeling was used to relate factors to four routine diabetes care utilization outcomes. Factor loadings were strong, and fit indices indicated good measurement model and full structural model fits. In the full structural equation model, household dysfunction was associated with decreased likelihood of meeting frequency recommendations for A1C testing (β = -0.22, p < .05) and foot exams (β = -0.29, p < .01). Physical and emotional abuse were associated with greater likelihood of meeting A1C testing frequency recommendations (β = 0.21, p < .05). Specific types of ACEs may differentially relate to routine diabetes care utilization in adulthood. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Point-of-Care HbA1c in Clinical Practice: Caveats and Considerations for Optimal Use.

Hemoglobin A1c (A1C) is widely used for the diagnosis and management of diabetes. Accurate measurement of A1C is necessary for optimal clinical value. Assay standardization has markedly improved the accuracy and consistency of A1C testing. Devices to measure A1C at point of care (POC) are commercially available, allowing rapid results when the patient is seen. In this review, we describe how standardization of A1C testing was achieved, leading to high-quality results in clinical laboratories. We address the use of POC A1C testing in clinical situations and summarize the advantages and disadvantages of POC A1C testing. We emphasize the importance of considering the limitations of these devices and following correct testing procedures to ensure that accurate A1C results are obtained for optimal care of patients.

Relationships between the Structural Characteristics of General Medical Practices and the Socioeconomic Status of Patients with Diabetes-Related Performance Indicators in Primary Care.

The implementation of monitoring for general medical practice (GMP) can contribute to improving the quality of diabetes mellitus (DM) care. Our study aimed to describe the associations of DM care performance indicators with the structural characteristics of GMPs and the socioeconomic status (SES) of patients. Using data from 2018 covering the whole country, GMP-specific indicators standardized by patient age, sex, and eligibility for exemption certificates were computed for adults. Linear regression models were applied to evaluate the relationships between GMP-specific parameters (list size, residence type, geographical location, general practitioner (GP) vacancy and their age) and patient SES (education, employment, proportion of Roma adults, housing density) and DM care indicators. Patients received 58.64% of the required medical interventions. A lower level of education (hemoglobin A1c test: β = -0.108; ophthalmic examination: β = -0.100; serum creatinine test: β = -0.103; and serum lipid status test: β = -0.108) and large GMP size (hemoglobin A1c test: β = -0.068; ophthalmological examination β = -0.031; serum creatinine measurement β = -0.053; influenza immunization β = -0.040; and serum lipid status test β = -0.068) were associated with poor indicators. A GP age older than 65 years was associated with lower indicators (hemoglobin A1c test: β = -0.082; serum creatinine measurement: β = -0.086; serum lipid status test: β = -0.082; and influenza immunization: β = -0.032). Overall, the GMP-level DM care indicators were significantly influenced by GMP characteristics and patient SES. Therefore, proper diabetes care monitoring for the personal achievements of GPs should involve the application of adjusted performance indicators.

Nutritional Interventions in Gestational Diabetes: A Nursing Perspective in Obstetrics

The study assessed the effectiveness of individualized nutritional counseling conducted by nurses in managing gestational diabetes mellitus. The intervention emphasized self-management and dietary adherence by organizing balanced meals, selecting foods with low glycemic index, and counting carbohydrates. This cross-sectional study identified 140 pregnant women diagnosed with gestational diabetes mellitus via convenient sampling. The research employed a systematic approach through structured questionnaires for data collection and hemoglobin A1c tests to assess glycemic regulation. The findings revealed substantial enhancements in glycemic control, as evidenced by the noteworthy reduction in hemoglobin A1c levels from 5.9% before the intervention to 5.4% following it (P &lt; 0.05). In addition to the decreased glycemic index of consumer foods, dietary modifications increased fiber consumption and decreased carbohydrate intake (P &lt; 0.05). Furthermore, the participants demonstrated a substantial adherence to the nutritional plan (84.7%) and conveyed contentment with the counseling they received (4.3 on a five-point scale). The research documented favorable changes in levels of physical activity and enhancements in health outcomes for both the mother and the newborn. These improvements encompassed reduced rates of preterm birth, fewer C-sections, and a decline in neonatal hypoglycemia instances.

Effects of Practice Ownership and Integration of Health Services on Adherence to Diabetes Guidelines.

There has been a trend toward hospital systems and insurers acquiring privately owned physician practices and subsequently converting them into vertically integrated practices. The purpose of this study is to observe whether this change in ownership of a medical practice influences adherence to clinical guidelines for the management of type 1 and type 2 diabetes. This is an observational study using pooled cross-sectional data (2014-2016 and 2018-2019) from the National Ambulatory Medical Care Survey, a nationally representative probability sample of US office-based physician visits. A total of 7499 chronic routine follow ups and preventative care visits to non-integrated (solo and group physician practices) and integrated practices were analyzed to see whether guideline concordant care was provided. Measures included 7 services that are recommended annually for individuals with type 1 and type 2 diabetes (HbA1c, lipid panel, serum creatinine, depression screening, influenza immunization, foot examination, and BMI). Compared to non-integrated physician practices, vertically integrated practices had higher rates of hemoglobin A1C testing (odds ratio 1.58 [95% CI 1.07-2.33], P < .05), serum creatine testing (odds ratio 1.53 [95% CI 1.02-2.29], P < .05), foot examinations (odds ratio 2.03 [95% CI 0.98-4.22], P = .058), and BMI measuring (odds ratio 1.54 [95% CI 0.99-2.39], P = .054). There was no significant difference in lipid panel testing, depression screenings, or influenza immunizations. Our results show that integrated medical practices have a higher adherence to diabetes practice guidelines than non-integrated practices. However, rates of services provided regardless of ownership were low.

An implementation science focused practice‐based research network for rural community pharmacies: RURAL‐CP

AbstractPractice‐based research networks (PBRNs) support the translation and evaluation of evidence‐based practices and interventions on a large scale and have primarily been used in primary care settings. Few pharmacy PBRNs exist. Our objective is to describe the composition and characteristics of the Rural Research Alliance of Community Pharmacies (RURAL‐CP), which is the first PBRN exclusively for rural community pharmacies. For each enrolled pharmacy, a pharmacist liaison completed a survey that assessed the pharmacy's operational characteristics, including business operations, human resource management, division of clinical responsibilities, technology and enhanced services, organizational context, and research priorities. Additionally, up to five other pharmacy staff members completed a brief survey on organizational context. Descriptive statistics were calculated. As of May 2023, there were 126 pharmacies across seven southeastern states that were enrolled in RURAL‐CP. Most pharmacies (91%) were independent pharmacies and operated 6 days per week (82%). On average, pharmacies employed 10 staff members and most trained student pharmacists. Pharmacies offered valuable services in their community, including immunizations, naloxone dispensing, and medication delivery. Blood glucose testing was the most common point‐of‐care (POC) test offered, and most pharmacies were interested in expanding POC offerings, particularly A1c testing and cholesterol screening. RURAL‐CP pharmacies have, on average, relatively strong organizational contexts and readiness for change. Pharmacists' top research priorities were expansion of clinical services, reimbursement, patient adherence, and addressing diabetes and hypertension. Although not generalizable to all rural pharmacies, results indicate that rural pharmacies deliver many important services in their communities and are interested in increasing services provided.

A comparison between different patient groups for diabetes management during phases of the COVID-19 pandemic: a retrospective cohort study in Ontario, Canada

BackgroundWith the onset of the COVID-19 pandemic and the large uptake in virtual care in primary care in Canada, the care of patients with type 2 diabetes has been greatly affected. This includes decreased in-person visits, laboratory testing and in-person assessments such as blood pressure (BP). No studies have investigated if these changes persisted with pandemic progression, and it is unclear if shifts impacted patient groups uniformly. The purpose of this paper was to examine changes in diabetes care pre, early, and later pandemic across different patient groups.MethodsA repeated cross-sectional design with an open cohort was used to investigate diabetes care in adults with type 2 diabetes for a 6-month interval from March 14 to September 13 over three consecutive years: 2019 (pre-pandemic period), 2020 (early pandemic period), and 2021 (later pandemic period). Data for this study were abstracted from the University of Toronto Practice-Based Research Network (UTOPIAN) Data Safe Haven, a primary care electronic medical records database in Ontario, Canada. Changes in diabetes care, which included primary care total visits, in-person visits, hemoglobin A1c (HbA1c) testing, and BP measurements were evaluated across the phases of the pandemic. Difference in diabetes care across patient groups, including age, sex, income quintile, prior HbA1c levels, and prior BP levels, were assessed.ResultsA total of 39,401 adults with type 2 diabetes were included in the study. Compared to the 6-month pre-pandemic period, having any in-person visits decreased significantly early pandemic (OR = 0.079 (0.076–0.082)), with a partial recovery later pandemic (OR = 0.162 (95% CI: 0.157–0.169). Compared to the pre-pandemic period, there was a significant decrease early pandemic for total visits (OR = 0.486 (95% CI: 0.470–0.503)), HbA1c testing (OR = 0.401 (95% CI: 0.389–0.413)), and BP measurement (OR = 0.121 (95% CI: 0.116–0.125)), with partial recovery later pandemic.ConclusionsAll measures of diabetes care were substantially decreased early pandemic, with a partial recovery later pandemic across all patient groups. With the increase in virtual care due to the COVID-19 pandemic, diabetes care has been negatively impacted over 1-year after pandemic onset.

The effects of non-bitter &lt;i&gt;Cucumis metuliferus&lt;/i&gt; fruit extract on blood sugar of high-fat/fructose diet and streptozotocin-induced type II diabetic Wistar Albino rats

Globally, diabetes mellitus (DM) remains one of the leading debilitating non-communicable diseases, with its prevalence projected to increase from 8.8% in 2015 to 10.0% in 2030. The management of diabetes mellitus remains a major challenge, and the number of diabetes-related deaths is projected to rise from 3.1 million in 2015 to 4.2 million in 2030. This continues to be a public health concern, particularly in developing countries where the majority of people are poor and predominantly live in rural areas, facing challenges in accessing healthcare services. However, the non-bitter Cucumis metuliferus fruit is being used for managing type 2 diabetes mellitus by some communities in Kenya, although its therapeutic benefits have not been adequately studied and proven. The study aimed to determine the effects of non-bitter Cucumis metuliferus fruit extract on blood sugar in high-fat/fructose diet and streptozotocin-induced type II diabetic Wistar albino rats. This study adopted an experimental laboratory-based design. A sample size of 64 male Wistar albino rats, aged 5 weeks and weighing between 90 and 130 grams, was randomly assigned to two major study groups: the control group and the experimental group. The experimental group received a high-fat/fructose diet plus streptozotocin (STZ) injection to induce diabetes mellitus, whereas the control group received a standard rodent pellet diet plus 0.9% normal saline injection. The experimental group was further divided into a positive control group treated with pioglitazone (the standard drug) at a dose of 20 mg/kg body weight, a low-dose CMFE group at 200 mg/kg body weight, and a high-dose CMFE group at 400 mg/kg body weight. Fasting blood sugar (FBS), oral glucose tolerance test (OGTT), and haemoglobin A1c (Hb A1c) tests were used as indicators, and the results were compared between the groups. The study findings revealed a significant statistical rise (P &lt;0.001) of FBS in the treatment group after induction of type II DM, followed by a decline to pre-induction levels after treatment. Similarly, there was a statistically significant increase (P &lt;0.001) of the OGTT after induction of type II DM, with the OGTT declining to pre-induction levels following treatment (P =0.106). The findings on both the FBS and OGTT tests indicate that treatment with CMFE controlled the blood sugar. Consequently, there was no significant difference (P =0.712) in Hb A1c test results between the control group and the treatment group at the end of the experiment, indicating that treatment with CMFE had a long-term control effect on blood sugar. This study concludes that the non-bitter CMFE possesses both short-term and long-term hypoglycemic properties in type II diabetes mellitus.

Analysis of HbA1c using microfluidic card (Capitainer qDBS card) as a pre-step before determination of the HbA1c value with an immunological method

The objective of the study was to evaluate Capitainer’s quantitative dried blood spots (qDBS) card for Hemoglobin A1c (HbA1c) testing. qDBS cards can be used for at-home sampling for HbA1c determination in a Swedish laboratory setting. A total of 153 routine requested HbA1c samples were used in this evaluation of microfluidic cards (qDBS). The HbA1c was extracted from the disc and HbA1c was determined at cobas 6000 instruments with immunological technology. The results were compared with results from traditional venous HbA1c testing. The reproducibility of using this elution procedure was 4.0% measured as coefficient of variation at a HbA1c concentration of 51 mmol/mol. Analytical performance specifications for HbA1c < 52 mmol/mol using DBS card (c501) compared with assigned values from Capillarys 3 was (y) = 1.03 x Capillarys 3(x) − 0.87; R2 = 0.97. There is a good agreement between HbA1c determined by traditional HbA1c testing and determination from Capitainer’s qDBS cards. This shows that the technology could be used for out-of doctor’s office testing.

Implementing point-of-care hemoglobin A1C testing in an obstetrics outpatient clinic.

A1C ≥6.0% is associated with increased risk of adverse outcomes in pregnant diabetic patients. A1C testing is recommended by the American Diabetes Association as a secondary measure of glycemic control in pregnant patients. To determine the utility of A1C point-of-care testing (POCT) during pregnancy to facilitate rapid counseling and diabetes care, particularly in relatively low-income transient patient populations. We performed a single-center, retrospective analysis of patients presenting to an outpatient obstetrics office with routine, in-laboratory A1C testing, before and after the implementation of POCT for A1C (n = 70 and n = 75, respectively). Demographics, results, physician referral to a nutritionist, counseling, and outcomes were retrieved from patient electronic medical records. In total, 9% and 23% of the in-laboratory and POCT groups, respectively, were referred for nutrition services (P = .02). Of these, 22% of the in-laboratory group and 42% of the POCT group received immediate counseling (P < .01). An inverse correlation was observed between A1C level at study entry and gestational weeks at delivery, with a Pearson r value of -0.39 (-0.58 to -0.16) for the in-laboratory group and -0.38 (-0.57 to -0.14) for the POCT group. No statistically significant difference in pregnancy outcomes was observed. Implementation of A1C POCT was associated with immediate counseling and management of the health of pregnant patients, but was not associated with improved outcomes, in a low-resource patient population.

Telemedicine use and decrements to type 2 diabetes and hypertension care during the COVID-19 pandemic

BackgroundWe examine pandemic-era quality of care changes associated with telemedicine use among adults with type 2 diabetes and/or hypertension across ten health systems.MethodsPatient-level encounter and laboratory data (n = 1,963,563) were analyzed for pre-pandemic (March 13, 2019 to December 31, 2019) and pandemic (March 13, 2020 to December 31, 2020) periods. Generalized linear models with binomial distribution functions and log links estimated the association of telemedicine use with four outcomes: 1) hemoglobin A1c (HbA1c) testing, 2) HbA1c control (< 8.0%), 3) blood pressure (BP) testing, and 4) BP control (< 140 / 90 mmHg), controlling for patient characteristics, system fixed effects, and with propensity score weights.ResultsIn adjusted analyses, telemedicine use was associated with lower odds of HbA1c (aOR = 0.74, p < 0.05) and BP (aOR = 0.40, p < 0.01) testing for adults with type 2 diabetes, but not HbA1c or BP control. Among hypertension-only patients, telemedicine use was associated with lower odds of BP testing (aOR = 0.10, p < 0.001), but not BP control. Compared to pre-pandemic telemedicine use, pandemic period telemedicine use was associated with lower odds of HbA1c and BP monitoring.DiscussionTelemedicine use was associated with lower odds of HbA1c monitoring for adults with type 2 diabetes and lower odds of BP testing for adults with type 2 diabetes and/or hypertension.ConclusionAs telemedicine continues to be used for diabetes and hypertension care, remote monitoring, standing orders, and community pharmacy partnerships may be necessary supplements to telemedicine to assure high quality care, especially when in-person care options are limited.

A laboratory-based cross-sectional study about helicobacter pylori infection and diabetes.

Despite the numerous articles discussing the relationship between diabetes mellitus type 2 (DMT2) and chronic Helicobacter pylori (H. pylori) infection the results have been inconsistent, necessitating further research. This study investigated the coexistence of Helicobacter pylori infection and DMT2. We conducted a study in selected laboratories in Tehran, measuring the H.Pylori stool antigen (HpSA) in individuals referred by physicians for a glycosylated hemoglobin A1c (HbA1c) test. Out of the 2500 patients who were referred to randomly selected laboratories, a total of 2025 (81%) patients had serum HbA1c levels above 6.5%. of 2025 patients with HbA1c levels above 6.5%, 1321 (52.84%) had HpSA in their stool. No significant gender difference was observed, with a mean age ± SD, 48.65 ± 7.55. HpSA was positive in 52.84% of the DM group, while in the non-DM group, HpSA was positive in 37.36% of cases. Fecal antigen titers are not related to gender (P = 0.274) but are related to age (r = 0.213, P=0.034). Long-term infection with Helicobacter pylori may be significantly associated with elevated HgA1c.Testing for H. pylori infection, regular monitoring of blood sugar and HbA1c levels in high-risk people can prevent DMT2.

Patient Characteristics Associated with Telemedicine Use for Diabetes Mellitus Care: Experience of a University Health System.

The objective was to understand the characteristics of patients who used telemedicine for diabetes management to inform future implementation of telemedicine. We examined patient characteristics associated with telemedicine use for diabetes mellitus (DM) care between March 1, 2020 and April 1, 2021 (the coronavirus disease 2019 pandemic period) in a large university health system when telemedicine visits increased rapidly. Logistic regression models assessed patient characteristics associated with telemedicine visits and delays in DM process measures (hemoglobin A1c checks, nephropathy, and retinopathy evaluations) during the pandemic period after adjusting for potential confounders and corresponding values before the pandemic period (March 1, 2019-February 29, 2020). A total of 45,159 patients were seen from 987,791 visits during the pandemic period. The number of visits averaged one visit less during the pandemic period than before the pandemic period. Approximately 5.4% of patients used telemedicine during the pandemic period from 42,750 visits. The mean (standard deviation) telemedicine visit was 1.28 (0.91). Men, Asian, Black, and other race (vs White), having Medicare or uninsured (vs private insurance), were less likely to use telemedicine. Patients with more visits before the pandemic period were more likely to use telemedicine and less likely to experience a delay in DM process measures during the pandemic period. Telemedicine users were 18% less likely to experience a delay in nephropathy visits than nonusers, but without difference for other process measures. Race, sex, insurance, and prepandemic in-person visits were associated with telemedicine use for DM management in a large health system. Telemedicine use was not associated with delays in hemoglobin A1c testing, nephropathy, and retinopathy assessments. Understanding reasons for not using telemedicine is important to be able to deliver equitable DM care.

Commutability and Uncertainty of Blood Hemoglobin A1c Testing Materials.

Hemoglobin A1C (HbA1C) is used to evaluate glycemic control over a three-month period. Blood matrix-based HbA1C materials are needed for quality control and evaluation of HbA1C measurements. This study investigated the commutability of blood materials (BMs) and aimed to upgrade BMs for HbA1C testing for use as proficiency test (PT) material. We measured BMs from a DM blood donor (n = 1), an in vitro glycation procedure (n = 3), and from commercial sources (n = 2) for HbA1C in parallel with fresh unprocessed BMs (n = 3) and clinical blood samples (n = 25). Two NGSP-certified methods, including a turbidimetric and an enzymatic immunoassay, were used for HbA1C determinations. Commutability as investigated according to CLSI EP14-Ed4 guidelines. The commutable BMs exhibited a mean paired difference of 0% to 9% when compared to reference methods, whereas the non-commutable BMs represented a mean paired difference of 3% to 11%. Fresh, unprocessed BMs with a low HbA1C of 6.0% were more commutable than BMs with a high HbA1C. The values of HbA1C in BMs (mean and uncertainty following ISO Guide 35 for RM production) were applied to upgrade the PT material to be used as a reference material. The relative uncertainty of BM-Ndm-1 and BM-Gcb-3 were 1 and 0.4%, respectively. The commutability of hemoglobin in BMs is dependent on the preparation process. Blood materials with a high HbA1C content are usually less commutable versus materials with low HbA1C content when prepared by the same process. Our study showed BMs can be successfully used as quality control or PT materials.

Longitudinal impact of COVID-19 pandemic on the utilization of hemoglobin A1c testing in outpatients

BackgroundDuring the COVID-19 pandemic, concerns arose about disparate access to health care and laboratory testing. There is limited information about the pandemic’s impact on the frequency of diabetic laboratory testing across demographic subgroups (e.g., sex, age over 65 y, and race). MethodsThis retrospective study examined outpatient hemoglobin A1c (HbA1c) testing in a large academic medical center in Upstate New York between March 2019 and March 2021. Multivariate Poisson regression models were used to evaluate the pandemic’s effects on HbA1c utilization. ResultsOver 190,000 HbA1c results from predominately white (76.1 %) and older (mean age, 60.6 y) outpatients were analyzed. Compared to pre-pandemic time period, the average number of HbA1c tests per patient during COVID time period experienced a small, though significant, drop (1.3 to 1.2; p < 0.001) on aggregate and in outpatients, males, females, and seniors. The modest reduction was not significant by race except for the white seniors (p < 0.001). However, the testing frequency remained within recommendations from the American Diabetes Association for monitoring prediabetic patients and patients with stable glycemic control. ConclusionGiven the propensity for healthcare disruptions to widen disparities, it is reassuring that we did not observe a worsening of disparities in rates of HbA1c testing during the COVID-19 pandemic.

Impact of Implementing Point of Care Hemoglobin A1C Testing in an Obstetrics Outpatient Clinic

Abstract Hemoglobin A1C ≥ 6.0% is associated with increased risk of adverse outcomes in pregnant, diabetic patients and is recommended as a secondary measure of glycemic control in pregnant patients by the American Diabetes Association. However, the utility of A1C point of care testing (POCT) during pregnancy to facilitate rapid counseling and diabetes care, particularly in relatively low-income transient patient populations is unknown. We performed a single center, retrospective analysis of patients presenting to an out-patient obstetrics office with routine, In-lab A1C (n= 70) testing and after the implementation of POCT for A1C (n=75). Demographics, results, physician referral to a nutritionist, counseling, and outcomes were retrieved from the electronic medical record. 9% and 23% of the In-lab group and POCT respectively were referred for nutrition services (p=0.02). 22% of the In-lab group and 42% of the POCT groups received immediate counseling (p&amp;lt;0.01). An inverse correlation was observed between entry A1C and the weeks at delivery with a Pearson r of -0.39 (-0.58-0.16) for the In-lab group and -0.38 (-0.57--0.14) for the POCT group. In conclusion, the implementation of POC A1C testing was associated with immediate counseling and management of pregnant patients.