Glucose Monitoring And Insulin Administration Safety - Newsroom
Glucose Monitoring and Insulin Administration Safety (November 5, 2012) Recent findings indicate that multi-use glucometers might not be as safe as originally intended. During 2010, one assisted living facility experienced a number of deaths from a spread of acute Hepatitis B. This outbreak and spread was later associated with the facilitys blood glucose monitoring process. However, this facility was not alone in experiencing an outbreak of Hepatitis B through its employment of multi-use blood glucose monitors. In fact, an earlier study conducted by Centers for Disease Control and Communication (CDC) covering the 2003-2004 timeframe formed the foundation of ongoing research and investigation into risks associated with multi-use blood glucose monitoring equipment. Within the United States since 2004, there have been 16 identified outbreaks of Hepatitis B linked to the monitoring equipment. As a follow up to these findings, onsite health care provider setting reviews and evaluations were conducted where these outbreaks were identified to have occurred. Part of the investigation and evaluation process included examining clinical records, risk factors and infection control practices. Staff and patients were interviewed during the process with their input considered in the summarized findings. The patient subgroup studied were patients who had ordered blood glucose monitoring, as this subgroup had the potential risk of being exposed to Hepatitis B. Patients not requiring blood glucose monitoring were not included in the subgroup and this sample group did not become infected with the Hepatitis B. As a result of the investigation, two unsafe infection control practices were identified The sharing of reusable fingerstick lancets approved for single patient use. A lack of thoro Continue reading >>
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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Comment On The Pros And Cons Of Continuous Glucose Monitoring For Patients With Type 1 Diabetes On Multiple Daily Injections Of Insulin. Authors Reply
, Volume 60, Issue1 , pp 197197 | Cite as Comment on The pros and cons of continuous glucose monitoring for patients with type 1 diabetes on multiple daily injections of insulin. Authors reply We are grateful to Dr. Frontino and colleagues for their comments [ 1 ] and interest in our work [ 2 ]. We acknowledge that type 1 diabetic patients treated with multiple daily injections (MDI) of insulin using continuous glucose monitoring (CGM) may benefit from the use of glucose rate of change (ROC) arrows to make insulin dose adjustments. ROC arrows indicate the direction and velocity of changing glucose, reflecting a combination of recent glucose readings. However, at least three glycemic measurements in the last 15 min are required to describe the glycemic trend. In order to make safe therapeutic decisions, the information on the velocity of changing glucose should be integrated with that coming from the trend graph and glycemic measurements by self-blood glucose monitoring. It remains to be clarified whether non-adjunctive use of CGM may be considered a valid tool to make treatment decisions. As Frontino pointed out, the forthcoming availability of more accurate sensors, with mean absolute relative difference (MARD) below 10%, will provide an important opportunity to monitor glucose levels and adjust therapy with CGM. In the REPLACE-BG trial [ 3 ], which randomized 226 type 1 diabetic adults to CGM-only or to CGM plus self blood glucose monitoring (SBGM), mean time in euglycemia (glucose values between 70-180 mg/dL) was similar in both groups. However, patients in the CGM-only group needed to perform at least 2.8 SBGM tests per day (mainly to calibrate the sensor), as compared with 5.4 tests of patients in CGM plus SBGM group. Moreover, confirmatory capillary glucose measu Continue reading >>
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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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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 >>
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 >>
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 >>
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Several Steps Forward: A New Meter For Multiple Patient Use
Several Steps Forward: A New Meter for Multiple Patient Use Huong T. Le , M.D. and Mark J. Rice , M.D. Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida Corresponding Author: Mark J. Rice, M.D., College of Medicine, University of Florida, P.O. Box 100254, Gainesville, FL 32610-0254; email address [email protected] Copyright 2013 Diabetes Technology Society Point-of-care (POC) blood glucose testing is becoming ubiquitous in the hospitals because of ease of use, timely results, and cost effectiveness. Historically, these POC devices were designed and regulated for home use by patients with diabetes. Their transition into the hospital multipatient setting has introduced the real risk of crosscontamination and has exposed inadequate accuracy standards. This article highlights some of the current recommendations for these devices and focuses on a new meter that addresses these issues. Although not currently approved for use in the United States, the OneTouch VerioPro blood glucose meter (LifeScan, Inc.), which is the topic of an article by MacRury and coauthors in this issue of the Journal of Diabetes Science and Technology, is a step forward with minimal interferences and good accuracy, and perhaps most importantly, is robust enough to withstand rigorous disinfection. Keywords: disinfection, glucose, hepatitis B virus, meter, point of care Historically, self-monitoring of blood glucose (SMBG) began with point-of-care (POC) meters that were designed, manufactured, and regulated for home use by patients with diabetes. This POC glucose testing has slowly migrated from the home into hospitals and other institutional care facilities because of their ease of use, timely results, and inexpensive cost model. The major drawback of these Continue reading >>
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- Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)
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 >>
- Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)
- NIHR Signal Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes
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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 such as blood glucose meters should be used only on one patient and not shared. Continue reading >>
Glucose Meter Accuracy: Fda's New Dual Call For Tighter Standards
Our patient community has been up in arms for quite some time about glucose meter accuracy, or rather lack thereof. Fortunately, the patient-initiated StripSafely campaign seems to have struck a chord, and the FDA has recently -- at long last -- issued new "draft guidance" on accuracy standards. What surprised a lot of people, though, is how FDA chose to split their recommendations into two categories: one set of requirements for meters purchased over-the-c ounter and used by patients in everyday life, and another for meters used in clinical settings by healthcare professionals. And guess which is required to be more accurate? You guessed it: +/-15% for home-use meters and a tighter +/-10% for clinical meters. On top of that, the new guidance is only aimed at NEW products getting ready to undergo FDA evaluation for the first time; it doesn't address the accuracy of meters already on the market -- which disappointed many of us calling for better "post-market surveillance" of meters that may be doing a crap job after some years of use. Also, the new guidance is "non-binding" for manufacturers, so not mandatory. Huh? Last week, the FDA hosted a teleconference led by Courtney Lias, Director of CDRH/Division of Chemistry and Toxicology, to address these concerns with patient advocates, physicians and interested members of the media. The main point Lias seemed to want to convey is that the FDA is trying to be practical here, by issuing what they believe to be reasonable and achievable guidelines. "The technology isn't currently sufficient for manufacturers to meet +/-10% accuracy at the huge volume of lay use, but for the smaller volume of tests done in clinical settings, they can... In an ideal world, everyone would have a meter that's within 5-10% of the accuracy reference, Continue reading >>
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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 >>
Palms Up For Glucose Monitoring
Diabetes Nurse Specialist, University of Michigan, Health System Ann Arbor, Mich. DO YOU HAVE a patient with diabetes who finds it painful to use her fingertip to draw blood samples for glucose monitoring? Although blood from the fingertip most accurately reflects changes in venous glucose levels, numerous nerve endings there may make testing painful and repeated sticks can lead to local tissue damage. That's why most blood glucose meters now offer the option of using blood from the fingertips, palm, upper arm, forearm, calf, or thigh, with some limitations. Studies have shown that using the palm (at the base of the thumb) gives similar results to blood drawn from the fingertip and is less painful. If the manufacturer's instructions indicate multiple options, your patient might choose to use one of the alternate sites at certain times to reduce the number of finger sticks. Patients who may benefit from alternate site testing are those who test their blood glucose level often, use their fingers for their work, or feel it's too painful to test on their fingers. First, make sure your patient is a good candidate for blood glucose self-monitoring. Self-monitoring is recommended for a patient who's taking insulin or one who has: unstable diabetes with severe swings in blood glucose levels within a 24-hour period a tendency to develop severe ketosis or hypoglycemia For a patient taking an oral diabetic agent, blood glucose self-monitoring is also recommended during periods of suspected hyper- or hypoglycemia and when the medication or dosage is modified. Check that your patient has discussed using her palm or another alternate site with her diabetes care provider before you teach her the technique. And make sure she understands when alternate site sampling is appropriate. Blo Continue reading >>
Blood Glucose Meter: How To Choose
Many types of blood glucose meters are available. Here's how to choose one that fits your needs and lifestyle. If you have diabetes, you'll likely need a blood glucose meter to measure and display the amount of sugar (glucose) in your blood. Exercise, food, medications, stress and other factors affect your blood glucose level. Using a blood glucose meter can help you better manage your diabetes by tracking any fluctuations in your blood glucose level. Many types of blood glucose meters are available, from basic models to more-advanced meters with multiple features and options. The cost of blood glucose meters and test strips varies, as does insurance coverage. Study your options before deciding which model to buy. Choosing the right meter When selecting a blood glucose meter, it can help to know the basics of how they work. To use most blood glucose meters, you first insert a test strip into the device. Then you prick a clean fingertip with a special needle (lancet) to get a drop of blood. You carefully touch the test strip to the blood and wait for a blood glucose reading to appear on the screen. When used and stored properly, blood glucose meters are generally accurate in how they measure glucose. They differ in the type and number of features they offer. Here are several factors to consider when choosing a blood glucose meter: Insurance coverage. Check with your insurance provider for coverage details. Some insurance providers limit coverage to specific models or limit the total number of test strips allowed. Cost. Meters vary in price. Be sure to factor in the cost of test strips. Ease of use and maintenance. Some meters are easier to use than others. Are both the meter and test strips comfortable and easy to hold? Can you easily see the numbers on the screen? How e Continue reading >>
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Continuous Glucose Monitoring With Multiple Daily Insulin Treatment: Outcome Studies
Original ArticlesOpen AccessOpen Access license Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies Continuous glucose monitoring (CGM) is developing into an increasingly useful tool for glucose monitoring and therapeutic guidance in the treatment of diabetes. Multiple daily doses of insulin (MDI) is the most common method for intensive insulin treatment of type 1 diabetes and is also becoming more common in the treatment of type 2 diabetes as an increasing population with type 2 diabetes experiences progressive beta cell loss. The clinical evidence demonstrating the benefit of CGM in the outcomes of patients treated with MDI is becoming clearer, particularly with the recent completion of several randomized clinical trials addressing both type 1 and 2 diabetes. This evidence is reviewed. It has been over 20 years since the association between glucose control and diabetes complications became irrefutable. 13 During this interval there has been great focus on development of pharmacological agents, including improved insulin products and multiple noninsulin agents with various mechanisms of action. 4 , 5 Yet, many individuals with diabetes fail to meet glucose goals considered appropriate for the prevention of chronic complications. 68 Patients are faced with numerous barriers to improved control, including inconvenience, cost, inertia in changing personal health habits, fear of weight gain, and fear of hypoglycemia. Since the publication of the DCCT in 1993, 1 insulin regimens have become increasingly complex in the effort to make the treatment of type 1 diabetes more effective, physiologic, and flexible. At the same time, it has become obvious that improved guidance for insulin dosing is necessary to attain lower glucose averages and imp Continue reading >>
- Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)
- Exercise and Glucose Metabolism in Persons with Diabetes Mellitus: Perspectives on the Role for Continuous Glucose Monitoring
- Continuous Versus Flash Glucose Monitoring To Reduce Hypoglycemia In Type 1 Diabetes
