Frequently Asked Questions (faqs) Regarding Assisted Blood Glucose Monitoring And Insulin Administration
Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration The following FAQs summarize inquiries from healthcare personnel received by CDC regarding best practices for performance of assisted blood glucose monitoring and insulin administration, including questions related to cleaning, disinfection, and storage of blood glucose monitoring equipment. These FAQs are not intended as a comprehensive resource for all issues related to blood glucose monitoring and insulin administration, and additional considerations may be necessary for certain clinical situations or settings. View more detailed information related to assisted blood glucose monitoring and insulin administration.Visit CDCs Injection Safety website for additional information regarding injection safety and CDCs Sharps Safety website information related to sharps safety and safe disposal of sharps in healthcare settings. Healthcare personnel are also encouraged to consult guidance provided by the Food and Drug Administration (FDA) (links provided in responses below) as well as the manufacturers of the devices (blood glucose meters, fingerstick/lancing devices, insulin pens) in use at their facilities. What is the difference between self-monitoring of blood glucose (SMBG) and assisted monitoring of blood glucose (AMBG)? With self-monitoring of blood glucose, individuals perform all steps of monitoring for themselves. With assisted monitoring of blood glucose, the same steps are followed but testing is performed for an individual or multiple persons by someone else (e.g., a caregiver or healthcare professional) [ 1 , 2 ]. Assisted monitoring of blood glucose is typically performed in healthcare settings such as clinics, hospitals, and long-term care settings (e.g., sk Continue reading >>
Acon Laboratories Announces Us Launch Of New On Call Pro Blood Glucose Meter For Multi-patient Use - Acon Labs
ACON Laboratories Announces US Launch of New On Call Pro Blood Glucose Meter for Multi-Patient Use ACON Laboratories Announces US Launch of New On Call Pro Blood Glucose Meter for Multi-Patient Use San Diego, CA, July 27, 2016 ACON Laboratories, Inc., a worldwide manufacturer in medical diagnostics including diabetes care products, continues to develop accurate and solutions-oriented glucose meter systems for markets requiring a high standard of reliability. In July, the company will offer the latest addition to the On Call line of diabetes care products available in the United States; a glucose meter system which is FDA-cleared and CLIA waived for multi-patient use.Ideal for use in Long Term Care, Post-Acute Care, Physician Offices, Correctional Healthcare, and Ambulatory Care markets, the On Call Pro combines the accuracy and ease-of-use seen in other On Call meters with valuable features designed to simplify and improve the process of multi-patient care. A Daily Control Test Reminder helps to ensure adherence to institutions quality control testing standards while features such as the strip ejector and patient-facing strip port reduce risk of contamination. The fast-wicking test strip allows the tiny blood sample (0.4L) to be obtained quickly and easily with minimal discomfort to patients while advanced technology built directly in the strip ensures an accurate result. To reduce time spent on testing procedures and avoid any wasted strips, the On Call Pro also provides re-dosing capability so that a second drop of blood can be applied to the same strip if not enough sample was provided on the first try.Required for use with single-use auto-disabling safety lancets only, the new OptiLance safety lancets also available from ACON Laboratories are recommended to be used Continue reading >>
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Omnis Health Launches Embracepro Blood Glucose Meter
Omnis Health Launches EmbracePro Blood Glucose Meter Intuity Medical Receives FDA Clearance to Market POGO Automatic Blood Glucose Monitoring System Omnis Health, a provider of diabetes monitoring systems, has announced the introduction of its new EmbracePro blood glucose meter for medical professionals. The EmbracePro blood glucose meter has been approved for multi-patient use. The device has a test strip release button for more hygienic strip disposal. Omnis Health's EmbracePro requires a small sample size and provides accurate results within five seconds. The blood glucose meter allows testing with less pain for the patient, using fingers, the palm, or forearm as alternate site testing locations. According to Omnis Health, new EmbracePro gold electrode test strips provide a shorter conductive path which increases accuracy and reliability. The EmbracePro can store storing up to 500 blood test results with date and time stamp, allowing for easy management of results for clinicians. Event recording mode of the device provides more effective data management, the firm claims. "Our company is committed to delivering healthcare innovations to both patients and clinicians," President Rob Burton said. "The EmbracePro is designed with professionals in mind. We know that clinicians need fast and accurate meters and EmbracePro provides that reliable technology." Continue reading >>
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- Postprandial Blood Glucose Is a Stronger Predictor of Cardiovascular Events Than Fasting Blood Glucose in Type 2 Diabetes Mellitus, Particularly in Women: Lessons from the San Luigi Gonzaga Diabetes Study
Letter To Manufacturers Of Blood Glucose Monitoring Systems Listed With The Fda
Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA OIVD has sent the following letter to manufacturers with blood glucose monitoring systems (BGMS) listed with the FDA. The letter outlines recent changes in the review of BGMS submissions. These review changes were instituted in response to a critical public safety risk concerning the risk of transmission of disease from shared use of fingerstick (lancing) devices and point of care blood testing devices. Your company has been identified as having listed blood glucose monitoring systems (BGMS) with the Food and Drug Administration [product code NBW]. The review of BGMS was recently changed in response to a critical public safety risk. The regulatory changes outlined in this letter are effective immediately and will apply to all new BGMS submissions to be submitted to OIVD. Please read the following in its entirety and include information on how you have addressed the following issues when preparing a BGMS pre-market submission for OIVD review. During the week of August 23, 2010, the FDA, CDC, and CMS issued clinical reminders and public health notifications highlighting the risk of transmission of disease from shared use of fingerstick (lancing) devices and point of care blood testing devices. The posting of these notifications was in response to recent outbreaks of viral hepatitis among patients where these devices were shared between users. The CDC and the FDA currently recommend the following: Lancing devices should never be used for more than one person. Only auto-disabling, single use lancing devices should be used for assisted blood glucose monitoring in multiple patients. Point of care blood testing devices Continue reading >>
Preventing Infections Related To Using Point-of-care Testing Devices
Home // ... // Clinical Laboratory News // CLN Articles // Preventing Infections Related to Using Point-of-Care Testing Devices Preventing Infections Related to Using Point-of-Care Testing Devices Author: Michael Astion, MD, PhD // Date: JAN.1.2013 // Source: Clinical Laboratory News The convenience and immediacy of point-of-care testing (POCT) has led to its use in many settings. But untrained or busy healthcare workers may overlook some basic sanitary practices when using POCT devices. This lack of attention is leading to nosocomial infections that can be attributed to contaminated devices. Here, Sharon M. Geaghan, MD, discusses how these infections occur and how to prevent them. Dr. Geaghan is professor of pathology and pediatrics at Stanford University School of Medicine in Palo Alto, Calif. Michael Astion, MD, PhD, chair of the Patient Safety Focus Editorial Advisory Board, conducted this interview. How would you sum up the problem related to POCT and nosocomial infections? Overall, I would say that there is a significant and pervasive lack of awareness about nosocomial infections associated with POCT, especially hepatitis B infections. In what settings do these infections occur? Typically, these infections occur during assisted monitoring of a POCT analyte. By assisted monitoring, I mean a POCT procedure performed by a nurse or other healthcare provider for the patient, rather than by the patient. Frequently, this involves a diabetic patient who is being helped with monitoring his or her blood glucose; however, any POCT device can transmit infection. These infections have been found in a variety of health care settings, including hospitals, ambulatory surgery centers, outpatient clinics, and assisted living facilities. What infectious agents are most likely to be Continue reading >>
The Bacterial Contamination Rate Of Glucose Meter Test Strips In The Hospital Setting
To assess the rate of bacterial contamination of the multi-use vial and single-use packed glucose meter strips, and to identify the type and frequency of various bacterial contamination in different hospital wards.This prospective observational study was conducted by a team from the Strategic Center for Diabetes Research in 7 general hospitals in the Central region of Saudi Arabia during the period fromAugust to September 2014 to assess the bacterial contamination rate of the unused strips. A total of 10,447 strips were cultured using proper agar media and incubated both aerobically and anaerobically.The total bacterial contamination rate for the multi-use vials glucose strips was 31.7%, while single-use packed strips were not contaminated at all. Ministry of Health hospitals had the highest contamination rates compared with other hospitals. Critical, obstetric, and surgical wards had the highest bacterial isolates number, where most were in the risk group 3 according to the National Institute of Health guidelines. Staphylococcus species were the most common bacteria found.Glucose meter strips should be recognized as a source of bacterial contamination that could be behind serious hospital acquired infections. The hospital infection control team should adopt proper measures to implement protocols for glucose meter cleaning and glucose strips handling. The snippet could not be located in the article text. This may be because the snippet appears in a figure legend, contains special characters or spans different sections of the article. The bacterial contamination rate of glucose meter test strips in the hospital setting. The bacterial contamination rate of glucose meter test strips in the hospital setting Khalid A. Al-Rubeaan , MD, FRCP(C), Amr T. M. Saeb , MSC, PhD, Dhe Continue reading >>
Cdc And Fda: Don’t Share!
It would seem to go without saying that devices used to puncture the skin — such as lancets and insulin pen needles — should never be shared by more than one person. In fact, these components are not officially considered reusable even by the same person, although as we noted in a previous post here at Diabetes Flashpoints, many people with diabetes reuse them anyway. But what about the reusable devices that these disposable components are paired with: lancing (fingerstick) devices and insulin pens? Can more than one person safely share them? The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recently addressed this question as it relates to devices in health-care settings. In coordinated statements, the agencies announced their position that lancing devices should never be used to obtain a blood sample from more than one person. The FDA noted that there has been a constant increase in reported instances of bloodborne infections being transmitted in health-care settings over the last 10–15 years, particularly involving the hepatitis B virus. The agency blames, in part, unclear labeling of multiple-use lancing devices for this trend. It has not always been made clear, says the agency, whether a device was approved for use on multiple patients or simply for multiple uses on the same patient. Furthermore, cleaning and disinfection instructions for these devices may have been inadequate. Therefore, even for devices the FDA previously cleared for use on multiple patients, the agencies say this practice should be discontinued. They even recommend using devices that physically cannot be reused, such as those on which the lancing blade permanently retracts after one use. But the agencies do not stop at lancing devices. They als Continue reading >>
New Attention On Poc Device Disease Transmission
New attention on POC device disease transmission April 2013When 19th-century Hungarian obstetrician Ignaz Semmelweis found that doctors could dramatically decrease puerperal infections by washing their hands with a chlorinated lime solution before delivering babies, his colleagues thought he was nuts. Why, everyone knew that infections were caused by noxious air! One hundred sixty-five years after Dr. Semmelweis discovery, hand hygiene has, of course, become accepted as one of the most important methods of preventing transmission of disease. Yet many hospitals are still struggling to convince their staff that routinely disinfecting another potential disease vectorpoint-of-care testing devices such as glucose meters and PT/INR metersis both crucial and effective. It really hasnt been understood that even though the meter doesnt necessarily touch the patient, cleaning and disinfection is still required, says Sharon Geaghan, MD, professor of pathology and pediatrics at Stanford University School of Medicine in Palo Alto, Calif. Thats really the point that I think has to be stressed: It can be an indirect contact transmission of the infectious agent from one patient to another through an intermediate contaminated object. And were not talking about just a few hospitals, either: Virtually all the published audits from government and independent investigators have underscored a substantial deficiency in a variety of institutions. Thats why the FDA, CDC, and CMS have all recently begun issuing guidance in the form of recommendations such as restriction of point-of-care devices to a single patient when possible, use of single-lancet devices that are auto-disabling for capillary blood sampling, strict adherence to hand hygiene, and attention to thorough disinfection and cleaning Continue reading >>
Glucometer To Use On Multiple Patients
I need to get a glucometer to use in a research study on multiple participants. I have 2 questions: 2. what single use disposable lancets do you like? Joined: Aug '04;Posts: 4,332; Likes: 7,526 I suppose it depends on the study. If you are studying people who routinely use lancets already, why not use theirs? They know what they like best for whatever reason. You would collect the blood on your own test strips depending on what meter you use, but I shouldn't think it makes a bit of difference on the sharp thing. Nope. They will be non-diabetic. We will be ruling that out at their study screening appt. And since it is a research study it is important we do each test exactly the same way using exactly the same equipment. Sorry, I should have clarified that in my original message. why don't you contact a marketing rep for Bayer or another type of equipment? They will probably give you the meter and maybe even give you strips. At least you save $60 or more on the meter. Lancets are pretty much universal remember the meter must be thoroughly cleaned with bleach cont. cleaner between patients and allowed to air dry..... remember the meter must be thoroughly cleaned with bleach cont. cleaner between patients and allowed to air dry..... Not taken as sarcasm. There is a lot of data out there about improper cleaning of the glucometer and also re-using single person use pen type lanceting devices and causing infection transmission. Probably not. This is policy at my facility. We use the Accu-Chek Inform. No, you and I are in long term care, where this is standard. I don't think Crunch is..... We currently use the purple version of these: I never knew what they were called. Capijet, I guess. We used to use the gray version of the Surgilance ( Lancet Needle, Lancet Gauge, Types of Continue reading >>
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Only Glucose Meters Accurate Enough To Be Fda-cleared For Use With All Patients, Including Critically Ill
ONLY glucose meters cleared by the FDA for use with all patients, in all professional healthcare settings, including critical care • Eliminates interference which cause incorrect glucose readings and misdosed insulin. ONLY glucose meters that are CLIA-waived for use with all patients including critically ill • Nursing and point-of-care (POC) operators can perform testing with all patients Accuracy proven in study of 1,698 critically ill patients with over 257 medical conditions • Improved accuracy results in fewer insulin misdoses and better outcomes for critically ill patients Excellent correlation to IDMS traceable laboratory methods • ONLY glucose meter proven to have no known clinical interferences • Tested over 8,000 medications with no interferences ONLY glucose measurement technology specifically designed for hospital use Wireless meter connectivity to LIS/HIS with StatStrip Glucose New breakthrough for use with critically ill In 2014, after an extensive, nearly four-year project conducted at five major university medical centers, Nova Biomedical achieved a major breakthrough in intended use for the StatStrip Glucose Hospital Meter System. In response to Nova’s 510(k) submission (K132121), the U.S. Food and Drug Administration (FDA) cleared StatStrip Glucose for use throughout all professional healthcare settings including critical care. It is the only glucose meter to obtain this clearance. “This device [StatStrip Glucose] provides an important public health resource for critically ill hospitalized patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading. It is important for manufacturers of glucose meters used in hospitals to design and test their devices for use in all hospitalized patients.”1 Continue reading >>
- A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes
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Fda Proposes Glucose Meter Guidance To Improve Infection Control In Nursing Homes, Hospitals
FDA proposes glucose meter guidance to improve infection control in nursing homes, hospitals FDA proposes glucose meter guidance to improve infection control in nursing homes, hospitals The U.S. Food and Drug Administration has drafted more stringent guidelines for blood glucose monitoring test systems used in nursing homes, hospitals and other healthcare settings. In the past, FDA regulations have not distinguished between glucose meters used in clinical settings and those used by individuals for self-monitoring, the draft guidance notes. However, the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention have raised concerns that some meters are not robust enough to withstand the rigors of use in professional settings, and could pose infection control risks. This is because meters can become contaminated with blood, and have been associated with the spread of diseases such as hepatitis. In response, the FDA is proposing separate specifications for glucose meters that would be used by clinicians. The 41-page draft guidance lays out the design elements that these meters would have to meet, and the information that device makers would have to provide in premarket submissions to the FDA. All parts of the meters used by healthcare professionals should be able to be easily and completely cleaned and disinfected, including seams and the test strip port, the guidance states. It describes potential labeling requirements, such as a warning that lancing devices are never to be used on multiple patients, and discusses effective cleaning agents. Device makers also should consider potential sources of error, including operator errors, software errors and errors caused by environmental factors, according to the guidance. It includes a table list Continue reading >>
Use Of Blood Glucose Meters Among People With Type 2 Diabetes: Patient Perspectives
The clinical value of regular self-monitoring of blood glucose (SMBG) in people with type 2 diabetes remains controversial. Some studies have found either no significant difference in A1C outcomes in groups performing or not performing SMBG1 or no evidence that SMBG confers benefits for outcomes other than A1C, such as mortality, long-term complications of diabetes, body weight, patient satisfaction, or quality of life.2 These studies2,3 have also indicated that there is “little indication that [patients are] using self-monitoring to effect and maintain behavior change.” One reason typically cited for the apparent lack of efficacy for SMBG in patients with type 2 diabetes is that patients simply do not adequately follow recommendations from their health care professionals.4 To date, few studies have explored the patients' perspective on SMBG beyond including standardized scales of “well-being” in more mechanized studies. In addition to formal recommendations from professional diabetes associations, leading diabetes clinicians and patient advocates with whom I am associated also disagree about the role of SMBG in the management of type 2 diabetes. My discussions with these individuals have provided further context for this topic. From them, I have heard: People with type 2 diabetes should not test very much at all because an A1C test performed every 3 months can provide sufficient information without the frustration of having to draw blood for daily tests that serve little purpose. Patients are just not getting the right education or motivation to be empowered to check their blood glucose levels and actually see the impact of their testing efforts. SMBG should be shifted from data collection to helping patients use the meter as a way to learn about their own body Continue reading >>
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Simulation Of A Multi-strip Blood Glucometer
Simulation of a multi-strip blood glucometer Abstract: Normal blood glucose levels are tightly regulated in the human body, in the range of 70-150 mg/dL. With the increasing awareness that uncontrolled diabetes plays a significant role in the onset and progress of other diseases, severely diabetic patients are being advised to closely monitor their haemoglucose levels, as often as four times every day. This is done in a home environment, by means of a glucometer and enzyme-coated test strips, having high specificity for glucose. The test strips are expensive and specific to the glucometer of a particular manufacturer, which implies that a patient is tied to one glucometer, making it economically unviable, especially in a developing country like India. Efforts are being made to develop a portable glucometer, which would accommodate, if not all, most of the commercial glucose test strips, available in the market today. As a first step, three of the most widely used test strips have been characterised and a circuit has been designed to obtain their current responses. This paper describes the simulation of the circuit and discusses the results obtained. Continue reading >>
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Nova Statstrip Glucose Hospital Meter System Approved For Use In Critical Care Patients
Nova StatStrip Glucose Hospital Meter System Approved for Use in Critical Care Patients Evidence-Based Diabetes Management > December 2014 Published on: December 05, 2014 Nova StatStrip Glucose Hospital Meter System Approved for Use in Critical Care Patients The FDA approved the Nova StatStrip Glucose Hospital Meter System for use among all hospitalized patients on September 24, 2014.1 Nova StatStrips system was first approved for such use by the FDA in 2006 to help monitor the effectiveness of a diabetes control program. The recent approval extends the use of this continuous glucose monitoring system in all capacities, including monitoring critically ill patients. Multiple studies have shown that Nova StatStrip, which is indicated for hospitalized patients on complex medication regimens, accurately reports blood glucose levels when healthcare providers test patients with a wide array of medical conditions, including cardiopulmonary disease, endocrine disorders, malignancies, obstetric or gynecologic issues, renal disease, surgery, and trauma. Moreover, this device can use arterial or venous whole blood obtained from hospitalized patients of all ages, including neonates, children, and adults. Glucometers (or blood glucose meters) are handheld instruments that allow healthcare workers to test blood glucose levels at the bedside. A single drop of blood pricked from the patients finger is applied to a plastic strip, which is then inserted into the glucometer. Glucose in the blood reacts with an enzyme on the test strip, and the chemical reaction creates an electrical current, which is measured and displayed as a surrogate for the blood glucose level. The Nova StatStrip functions by using a modified glucoseoxidase-based amperometric test.2 This device also corrects for int Continue reading >>
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All-in-one Meters: Now You See Them... Or Not
The idea of an all-in-one glucose meter that eliminates the need to carry around a bunch of separate D-supplies is so appealing! But in many respects it's like the mirage of water on the desert horizon that we can never reach. Many companies have promised glucose meters with built-in lancets and test strips to make D-management all the easier for us PWDs (people with diabetes), but so far they've all been vaporware. Recently, one of these all-inclusive device developers caught our eye in that it was named by MedCity News as a top company investors should be watching in the near future: Pepex Biomedical in St. Louis, MN, which is creating a line of glucose monitoring products that it believes will "change the game" for diabetes devices. The company's not a new kid on the block; Pepex has been around since 2009 and for four years has been working on its all-inclusive meter platform called Trio. Different than traditional meters that use a strip to measure blood from a lancet-pricked fingertip, the Trio actually won't draw any blood but will instead test the blood at the tissue source, the company says. The meter itself will be about the size of an iPhone, and you'll be able to snap on a slim, side-loaded disposable cartridge that houses a supply of plastic molded glucose test "chips" that consolidate a lancet and glucose checking technology in one piece. Meter Magic This is all based on Pepex's proprietary Conductive Composite Monofilaments (CCM) for detecting blood glucose levels -- electrochemical biosensors inside the cartridge that are composed of single strands of fiber about the diameter of a human hair. While the company markets the cartridges as being able to hold "a week's worth of chips," there is no clear number at this time on how many that might entail. Once Continue reading >>
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