Hba1c Monitoring Guidelines

Hba1c Testing Frequency: A Review Of The Clinical Evidence And Guidelines

HbA1c Testing Frequency: A Review of the Clinical Evidence and Guidelines Rapid Response Report: Summary with Critical Appraisal Copyright 2014 Canadian Agency for Drugs and Technologies in Health. Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions. Clinical testing is an essential part of the health care process and is utilized primarily to give insight into a patients condition. In addition, testing will indicate what choices a physician should make in order to benefit a patient and help to modify their therapy in response to fluctuating disease states. In diabetes diagnosis and monitoring one of the primary tests conducted is a hemoglobin A1c, or HbA1c, test. This is a measure of -N-(1-deoxy)-fructosyl hemoglobin contained within the red blood cell which is glycated in varying amounts depending on blood glucose levels over time. This protein is found within the red blood cell for its entire life span of approximately 120 days. For diagnosis and monitoring, HbA1c analysis is much easier for a pati Continue reading >>

Monitoring Diabetes - Hemocue

Monitoring: What to measure; How to measure. Comparing the most used guidelines related to targets for monitoring a patient with diabetes gives an indication of type of test and frequency. In 2017, American Diabetes Association (ADA), published their updated Standards of Medical Care in Diabetes. Their recommendations include screening, diagnostic, and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. In the updated Standards of Medical Care, ADA included a section describing how often certain tests should be done and what goals a patient should achieve. All patients diagnosed with diabetes should regularly receive a comprehensive diabetes evaluation to determine the stability of their disease, response to medications, and evaluate any associated complications. For a full description see Standards of Medical Care in Diabetes 2017. ADA recommends HbA1c POCT whenever possible A key test which should be performed at least 2-3 times a year is hemoglobin A1c (HbA1c). In patients who are unstable or who have recently changed medications, the tests should be done quarterly. The ADA also recommends that providers utilize POCT for HbA1c to provide an opportunity for more timely treatment changes. In addition to HbA1c levels, an albumin:creatinine ratio (ACR) should be done more than once per year, including at least 3 tests in 6 months for confirmation after diagnosis and additionally after changes in medications. Fasting lipid panels including LDL should be done at diagnosis, additionally to monitor therapy adherence, and annually along with liver function tests. Other tests at time of diagnosis should include serum creatinine and glomerular filtration rates. The ADA also recommends that blood pressure (BP) be evaluat Continue reading >>

Diagnosis

It's important for diabetes to be diagnosed early so treatment can be started as soon as possible. If you experience the symptoms of diabetes, visit your GP as soon as possible. They'll ask about your symptoms and may request blood and urine tests. Your urine sample will be tested for glucose. Urine doesn't normally contain glucose, but glucose can overflow through the kidneys and into your urine if you have diabetes. If your urine contains glucose, a specialised blood test known as glycated haemoglobin (HbA1c) can be used to determine whether you have diabetes. Glycated haemoglobin (HbA1c) In people who have been diagnosed with diabetes, the glycated haemoglobin (HbA1c) test is often used to show how well their diabetes is being controlled. The HbA1c test gives your average blood glucose levels over the previous two to three months. The results can indicate whether the measures you're taking to control your diabetes are working. If you've been diagnosed with diabetes, it's recommended you have your HbA1c measured at least twice a year. However, you may need to have your HbA1c measured more frequently if: you've recently been diagnosed with diabetes your blood glucose remains too high your treatment plan has been changed Unlike other tests, such as the glucose tolerance test (GTT), the HbA1c test can be carried out at any time of day and doesn't require any special preparation, such as fasting. However, the test can't be used in certain situations, such as during pregnancy. The advantages associated with the HbA1c test make it the preferred method of assessing how well blood glucose levels are being controlled in a person with diabetes. HbA1c can also be used as a diagnostic test for diabetes and as a screening test for people at high risk of diabetes. HbA1c as a diagno Continue reading >>

Diabetes Mellitus: Assessing Fitness To Drive

✘- Must not drive ! - May continue to drive subject to medical advice and/or notifying the DVLA ✓- May continue to drive and need not notify the DVLA Diabetes mellitus Insulin-treated drivers are sent a detailed letter from the DVLA explaining the licensing requirements and driving responsibilities. All drivers with diabetes must follow the information provided in ‘Information for drivers with diabetes’, which includes a notice of when they must contact the DVLA (see Appendix D). Insulin-treated diabetes Impaired awareness of hypoglycaemia The Secretary of State’s Honorary Medical Advisory Panel on Driving and Diabetes has defined impaired awareness of hypoglycaemia for Group 1 drivers as ‘an inability to detect the onset of hypoglycaemia because of total absence of warning symptoms’. Group 2 drivers must have full awareness of hypoglycaemia. ‘Severe’ is defined as hypoglycaemia requiring another person’s assistance. Group 1 Car and motorcycle Group 2 Bus and lorry ! - Must meet the criteria to drive and must notify the DVLA. All the following criteria must be met for the DVLA to license the person with insulin-treated diabetes for 1, 2 or 3 years: ■ adequate awareness of hypoglycaemia ■ no more than 1 episode of severe hypoglycaemia in the preceding 12 months ■ practises appropriate blood glucose monitoring as defined below ■ not regarded as a likely risk to the public while driving ■ meets the visual standards for acuity and visual field (see Chapter 6, visual disorders). ! - Must meet the criteria to drive and must notify the DVLA. All the following criteria must be met for the DVLA to license the person with insulin-treated diabetes for 1 year (with annual review as indicated last below): ■ full awareness of hypoglycaemia ■ no episo Continue reading >>

Hba1c Monitoring In Gestational Diabetes (query Bank)

Question Is there any place to monitor glycosylated hemoglobin (HbA1c) in pregnant women with gestational diabetes? Especially in relation to predicting fetal morbidity such as macrosomia/ shoulder dystocia? Answer This clinical query answer was produced by RCOG Library staff following the clinical query protocol. Please note: the search for this response was carried out over 1 year ago. Eligible users may request an update of the evidence by submitting a new clinical query. The NICE guideline on diabetes in pregnancy (National Collaborating Centre) recommends that HbA1c should not be used routinely for assessing glycaemic control in the second and third trimesters of pregnancy. The International Diabetes Foundation global guideline on pregnancy and diabetes makes the following recommendation for Management of gestational diabetes: “Do not use routine measurement of HbA1c for management” (Evidence level IV) A systematic review of antepartum A1C, maternal diabetes outcomes, and selected offspring outcomes (Katon, 2011) found A1C at gestational diabetes mellitus (GDM) diagnosis was positively associated with post-partum abnormal glucose. Women with post-partum T2DM or impaired glucose tolerance had mean A1C at GDM diagnosis higher than those with normal post-partum glucose (P <= 0.002) and a 1% increase in A1C at GDM diagnosis was associated with 2.36 times higher odds of post-partum abnormal glucose 6 weeks after delivery [95% confidence interval 1.19, 4.68]. The association of A1C and birthweight varied substantially between studies, with correlation coefficients ranging from 0.11 to 0.51. Other recently published studies have found conflicting relationships between HbA1c levels and infant outcomes, but some correlation with maternal outcomes: Katon et al (2012) rep Continue reading >>

Frequency Of Monitoring Hemoglobin A1c And Achieving Diabetes Control

Objectives: The American Diabetes Association recommends measuring hemoglobin A1C levels (A1C) at least semiannually in diabetic patients who have stable glycemic control and quarterly in patients whose therapy has changed or who are not meeting glycemic goals. These guidelines were based on expert consensus without reference to actual clinical data. The main objective of this study was to assess association between meeting a target A1C level of <7% and adherence to monitoring guidelines. Secondary objectives were to determine the proportion of diabetic patients in the authors’ practice who met the A1C monitoring guidelines and to assess whether meeting the target A1C level is associated with other information easily abstracted from patients records, namely age, gender, and types of therapy. Methods: This study employed a case control design. Records of 193 type 2 diabetic patients seen over a 6-month period in a rural family medicine clinic were analyzed. Assessment of diabetes control was based on the most recent A1C level, with <7% considered controlled. Adherence to guidelines was assessed by determining frequency of testing during the preceding 12-month period. Results: Ninety-eight patients (51%) adhered to the American Diabetes Association guidelines on frequency of monitoring A1C. Median levels of adherent and nonadherent patients differed significantly (6.5 vs 7.3, P < .001, Mann-Whitney test). Logistic regression analysis showed that “diabetes control” based on the A1C level is positively associated with adherence to the guidelines, negatively associated with intensity of therapy, and not associated with gender or age. Conclusion: This study supports the usefulness of American Diabetes Association practice guidelines on the frequency of monitoring A1C le Continue reading >>

Cg-dme-38 Continuous Interstitial Glucose Monitoring

This document addresses the use of continuous interstitial glucose monitoring devices, also referred to as CIGM or CGM devices, which are used to assist in the management of some forms of diabetes. Note: For information regarding the use of external insulin pumps, please see: Professional, intermittent, short-term use of continuous interstitial glucose monitoring devices as an adjunct to standard care is considered medically necessary in the care of individuals with type 1 diabetes, when all of the following criteria are met: Inadequate glycemic control despite compliance with frequent self-monitoring (at least 4 times per day) and including fasting hyperglycemia (greater than 150 mg/dl) or recurring episodes of severe hypoglycemia (less than 50 mg/dl). This poor control is in spite of compliance with multiple alterations in self-monitoring and insulin administration regimens to optimize care; and Insulin injections are required 3 or more times per day or an insulin pump is used for maintenance of blood sugar control; and Four or more fingersticks are required per day; and Monitoring and interpretation are under the supervision of a physician; and The device is only used for 6, 7, or 14 consecutive days on an appropriate, periodic basis. Personal long-term use of continuous interstitial glucose monitoring devices as an adjunct to standard care is considered medically necessary for any of the following: Adults (greater than or equal to 25 years old) with type 1 diabetes who meet the following criteria: Inadequate glycemic control, demonstrated by HbA1c measurements between 7.0% and 10.0%, despite: Compliance with frequent self-monitoring (at least 4 times per day); and Multiple alterations in self-monitoring and insulin administration regimens to optimize care; and Insu Continue reading >>

Hba1c Test

HbA1c is a blood test that is used to help diagnose and monitor people with diabetes. It is also sometimes called a haemoglobin A1c, glycated haemoglobin or glycosylated haemoglobin. What is being tested? HbA1c refers to glucose and haemoglobin joined together (’glycated’). Haemoglobin is the protein in red blood cells that carries oxygen throughout your body. The amount of HbA1c formed is directly related to the amount of glucose in your blood. Red blood cells live for up to 4 months, so HbA1c gives an indication of how much sugar you’ve had in your blood over the past few months. It’s different to the blood glucose test, which measures how much sugar you have in your blood at that moment. Why would I need this test? The test for HbA1c indicates how well your diabetes has been controlled over the last few months. It can also be used to diagnose diabetes. People with diabetes are advised to have this test every 3-6 months, or more frequently if it is not under control. This is important. The higher the HbA1c, the greater the risk of developing complications such as problems with your eyes and kidneys. How to prepare for this test No preparation is needed for this test. Understanding your results If you have not previously been diagnosed as having diabetes, an HbA1c of 6.5% or more can indicate that you do have diabetes. If your level is lower than this, you might need other tests to check whether you have diabetes or not. If you do have diabetes, your doctor will usually aim for an HbA1c of 6.5-7%. If the HbA1c is higher than the target range, your doctor may consider changing your treatment or closer monitoring. There are some medical conditions, such as anaemia, that change red blood cells and affect your HbA1c result. You should discuss the results with your Continue reading >>

Symptoms, Diagnosis & Monitoring Of Diabetes

According to the latest American Heart Association's Heart Disease and Stroke Statistics, about 8 million people 18 years and older in the United States have type 2 diabetes and do not know it. Often type 1 diabetes remains undiagnosed until symptoms become severe and hospitalization is required. Left untreated, diabetes can cause a number of health complications. That's why it's so important to both know what warning signs to look for and to see a health care provider regularly for routine wellness screenings. Symptoms In incidences of prediabetes, there are no symptoms. People may not be aware that they have type 1 or type 2 diabetes because they have no symptoms or because the symptoms are so mild that they go unnoticed for quite some time. However, some individuals do experience warning signs, so it's important to be familiar with them. Prediabetes Type 1 Diabetes Type 2 Diabetes No symptoms Increased or extreme thirst Increased thirst Increased appetite Increased appetite Increased fatigue Fatigue Increased or frequent urination Increased urination, especially at night Unusual weight loss Weight loss Blurred vision Blurred vision Fruity odor or breath Sores that do not heal In some cases, no symptoms In some cases, no symptoms If you have any of these symptoms, see your health care provider right away. Diabetes can only be diagnosed by your healthcare provider. Who should be tested for prediabetes and diabetes? The U.S. Department of Health and Human Services recommends that you should be tested if you are: If your blood glucose levels are in normal range, testing should be done about every three years. If you have prediabetes, you should be checked for diabetes every one to two years after diagnosis. Tests for Diagnosing Prediabetes and Diabetes There are three ty Continue reading >>

Test Center

Test Guide Laboratory Testing for Diabetes Diagnosis and Management This Test Guide discusses the use of laboratory tests (Table 1) for diagnosing diabetes mellitus and monitoring glycemic control in individuals with diabetes. Diagnosis Tools for diagnosing diabetes mellitus include fasting plasma glucose (FPG) measurement, oral glucose tolerance tests (OGTT), and standardized hemoglobin A1c (HbA1c) assays (Table 2). FPG and OGTT tests are sensitive but measure glucose levels only in the short term, require fasting or glucose loading, and give variable results during stress and illness.1 In contrast, HbA1c assays reliably estimate average glucose levels over a longer term (2 to 3 months), do not require fasting or glucose loading, and have less variability during stress and illness.1,2 In addition, HbA1c assays are more specific for identifying individuals at increased risk for diabetes.1 Clinically significant glucose and HbA1c levels are shown in Table 2.1 The American Diabetes Association® (ADA) recommends using these values for diagnosing diabetes and increased diabetes risk (prediabetes). Management Following a diagnosis of diabetes, a combination of laboratory and clinical tests can be used to monitor blood glucose control, detect onset and progression of diabetic complications, and predict treatment response. Table 3 shows the recommended testing frequency and target results for these tests. Different laboratory tests are available for monitoring blood glucose control over the short, long, and intermediate term to help evaluate the effectiveness of a management plan.1 Self-monitoring of blood glucose (SMBG) is useful for tracking short-term treatment responses in insulin-treated patients, but its usefulness is less clear in non–insulin-treated patients.1 By co Continue reading >>

Nice Guidelines & Funding Continuous Glucose Monitoring

NICE guidelines & funding continuous glucose monitoring NICE guidelines & funding continuous glucose monitoring 1.6.22Consider real-time continuous glucose monitoring for adults with type 1 diabetes who are willing to commit to using it at least 70% of the time and to calibrate it as needed, and who have any of the following despite optimised use of insulin therapy and conventional blood glucose monitoring: More than 1 episode a year of severe hypoglycaemia with no obviously preventable precipitating cause. Complete loss of awareness of hypoglycaemia Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities. Hyperglycaemia (HbA1c level of 75 mmol/mol [9%] or higher) that persists despite testing at least 10 times a day (see recommendations 1.6.11 and 1.6.12). Continue real-time continuous glucose monitoring only if HbA1c can be sustained at or below 53 mmol/mol (7%) and/or there has been a fall in HbA1c of 27 mmol/mol (2.5%) or more. [New 2015] 1.6.23 For adults with type 1 diabetes who are having real-time continuous glucose monitoring, use the principles of flexible insulin therapy with either a multiple daily injection insulin regimen or continuous subcutaneous insulin infusion (CSII or insulin pump) therapy. [New 2015] 1.6.24 Real-time continuous glucose monitoring should be provided by a centre with expertise in its use, as part of strategies to optimise a persons HbA1c levels and reduce the frequency of hypoglycaemic episodes. [New 2015] NICE Guidelines for managing diabetes with Continuous Glucose Monitoring in children: 1.2.62Offer ongoing real-time continuous glucose monitoring with alarms to children and young people with type 1 diabetes who have: impaired awareness of hypoglycaemia associated with advers Continue reading >>

Screening And Monitoring Of Prediabetes

Screening for Prediabetes AACE recommends that individuals who meet any of the clinical risk criteria noted below should be screened for prediabetes or type 2 diabetes (T2D) (1). Age ≥45 years without other risk factors CVD or family history of T2D Overweight or obese Sedentary lifestyle Member of an at-risk racial or ethnic group: Asian African American Hispanic Native American (Alaska Natives and American Indians) Pacific Islander High-density lipoprotein cholesterol (HDL-C) <35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L) Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and/or metabolic syndrome Polycystic ovary syndrome (PCOS), acanthosis nigricans, or nonalcoholic fatty liver disease (NAFLD) Hypertension (blood pressure >140/90 mm Hg or on antihypertensive therapy) History of gestational diabetes or delivery of a baby weighing more than 4 kg (9 lb) Antipsychotic therapy for schizophrenia and/or severe bipolar disease Chronic glucocorticoid exposure Sleep disorders in the presence of glucose intolerance (A1C >5.7%, IGT, or IFG on previous testing), including obstructive sleep apnea (OSA), chronic sleep deprivation, and night-shift occupation In the event of normal results, repeat testing at least every 3 years. Clinicians may consider annual screening for patients with 2 or more risk factors (1). Medications and Prediabetes Risk Specific medications that increase prediabetes risk include: Antidepressants: The ongoing use of antidepressant medications may modestly increase the risk of developing prediabetes or T2D, although the elevation in absolute risk is modest (2). Psychotropic agents: Certain treatments for schizophrenia or bipolar disease may increase prediabetes, T2D, and/or CVD risk. Substantial weight gain has b Continue reading >>

Hba1c And Monitoring Glycaemia

This article forms part of our ‘Tests and results’ series for 2012, which aims to provide information about common tests that general practitioners order regularly. It considers areas such as indications, what to tell the patient, what the test can and cannot tell you, and interpretation of results. Proteins in the body chemically react with glucose and become glycosylated. HbA1c is glycosylated haemoglobin and reflects the average blood glucose over the lifespan of the red blood cells containing it. HbA1c is regarded as the gold standard for assessing glycaemic control. HbA1c is also known as A1c, glycohaemoglobin and glycated haemoglobin. When should HbA1c be ordered? HbA1c reflects average glycaemia over the preceding 6–8 weeks. The test is subsidised by Medicare up to four times in a 12 month period.1 In some patients, HbA1c may be measured more frequently than 3 monthly to closely monitor glycaemic control (eg. in pregnancy when up to six tests in a 12 month period can be subsidised).1 The Service Incentive Program for diabetes care requires at least one HbA1c measurement per year. It is suggested that HbA1c is done every 6 months if meeting target, or every 3 months if targets are not being met or if therapy has changed.2 Self blood glucose monitoring (BGM) and HbA1c complement each other: BGM informs the patient about blood glucose at any particular time (eg. when the patient feels hypoglycaemic) and informs the patient and doctor about the glycaemic pattern over the 24 hour cycle and guides the timing and level of lifestyle intervention and hypoglycaemic therapy. What do I tell my patient? HbA1c is tested using venous blood, taken at any time of day and without any preparation such as fasting. In the paediatric setting, a finger-prick capillary sample can Continue reading >>

Letter To Manufacturers With Hba1c Assays Listed With The Fda

OIVD has sent the following letter to manufacturers with HbA1c assays listed with the FDA. [Manufacturer address] Dear [Contact name]: Recently, the American Diabetes Association (ADA) published updated recommendations for medical practice standards in diabetes1. According to these new recommendations, Hemoglobin A1c (HbA1c) values ≥ 6.5%2 may now be used to diagnose diabetes. This recommendation is supported by data collected as part of the Diabetes Control and Complications Trial (DCCT) as well as numerous other studies performed over the past two decades. Other clinical organizations, such as the American Association of Clinical Endocrinologists and the Endocrine Society have since expressed qualified support of this new recommendation. As a result of the recent change in practice guidelines, we have received a number of inquiries from manufacturers on whether their cleared tests may be promoted for use in diagnosing diabetes. Currently, all HbA1c tests that have been cleared by the Food and Drug Administration (FDA) have been indicated to monitor long-term glucose control in individuals with diabetes mellitus. Devices cleared with this type of indication would need a new FDA clearance to allow promotion of the device for the diagnosis of diabetes. To date, no HbA1c tests have been cleared with a diagnosis claim, but we believe that certain devices may be able to obtain such a claim with data demonstrating that they are accurate and reliable enough for this purpose. Your company has been identified as having listed HbA1c assay(s) with the FDA [product code LCP or NGB]. If you are interested in pursuing this new claim for your HbA1c test and have met the current NGSP criteria for certification, we encourage you to contact us, via a Pre-IDE submission, to discuss the Continue reading >>

Continuous Glucose Monitoring: An Endocrine Society Clinical Practice Guideline

Continuous Glucose Monitoring: An Endocrine Society Clinical Practice Guideline Mills-Peninsula Health Services (D.C.K.), San Mateo, California 94401 Search for other works by this author on: Stanford University School of Medicine (B.B.), Stanford, California 94305 Search for other works by this author on: Aarhus University Hospital (J.S.C.), 8000 Aarhus C, Denmark Search for other works by this author on: Mayo Clinic (V.M.M.), Rochester, Minnesota 55905 Search for other works by this author on: Yale University School of Medicine (W.V.T.), New Haven, Connecticut 06510 Search for other works by this author on: Walter Reed National Military Medical Center (R.A.V.), Bethesda, Maryland 20889 Search for other works by this author on: Joslin Diabetes Center (H.W.), Boston, Massachusetts 02215 Search for other works by this author on: The Journal of Clinical Endocrinology & Metabolism, Volume 96, Issue 10, 1 October 2011, Pages 29682979, David C. Klonoff, Bruce Buckingham, Jens S. Christiansen, Victor M. Montori, William V. Tamborlane, Robert A. Vigersky, Howard Wolpert; Continuous Glucose Monitoring: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 96, Issue 10, 1 October 2011, Pages 29682979, The aim was to formulate practice guidelines for determining settings where patients are most likely to benefit from the use of continuous glucose monitoring (CGM). The Endocrine Society appointed a Task Force of experts, a methodologist, and a medical writer. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. One group meeting, several conference calls, and e-mail Continue reading >>