1 / 28

Only Glucose Meter Cleared Under the New Higher Accuracy FDA Self-test Guidelines

Only Glucose Meter Cleared Under the New Higher Accuracy FDA Self-test Guidelines Nova Max. A complete diabetes measuring system including ketones and cholesterol. Nova Max OTC Meter A Diabetes Measuring System For the Serious Patient.

misha
Download Presentation

Only Glucose Meter Cleared Under the New Higher Accuracy FDA Self-test Guidelines

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Only Glucose Meter Cleared Under the New Higher Accuracy FDA Self-test Guidelines • Nova Max A complete diabetes measuring system including ketones and cholesterol

  2. Nova Max OTC Meter ADiabetes Measuring SystemFor the Serious Patient Initiated by competitive bidding, there has been a single-minded focus on reducing the cost of glucose meters and strips for diabetes self-testing. The result has been an influx of cheap, analytically inferior glucose meters that totally ignore the needs of the serious diabetes patient. To correct this problem, in 2016 the FDA imposed new, higher standards for clearance of new self-test meters. Nova Max is the only meter to have passed these new more accurate standards. There is a significant population of patients who are committed to carefully managing their diabetes and its co-morbidities. Their care is compromised by inaccurate glucose meters with interferences that can cause large insulin dosing errors and glucose variability including hypoglycemia. These patients include both type 1 and some type 2 diabetics such as: • Juvenile diabetics • Adult diabetics with serious commitment to self-management • Diabetes in pregnancy • Pre-diabetics The Nova Max is the only glucose meter with no interferences. It also has companion tests for ketones and cholesterol. It fills a need for the serious diabetes patients who want improvements in their ability to control diabetes.

  3. Nova Max OTC Meter A Diabetes Measuring SystemFor the Serious Patient Summary • Usesthe only glucose strip approved by the FDA using their new higher accuracy standard and their new meter accuracy rating system. • Includes testing for ketones. ADA recommends testing for life threatening DKA whenever glucose exceeds 250 mg/dl. Ketone revenues are 8% of Nova’s self-test glucose revenues and add nothing to the meter cost. • Includes testing for cholesterol, the most serious consequence of diabetes – over 84% of people with diabetes die from cholesterol caused cardiovascular disease, not from abnormal glucose levels! Cholesterol testing adds nothing to the meter cost. • All three strips and meter are CE marked. Glucose and ketones are FDA approved. The new cholesterol strip 510K submission is being prepared.

  4. Only glucose meter system cleared under the new higher accuracy FDA standard • On October 11th, 2016, the FDA published new clearance guidelines for SMBG meters designed to require manufacturers to improve accuracy. The guidelines also require new labeling so users understand the accuracy of the meters they are buying. • In December, 2017, Nova Max was the first SMBG meter to gain clearance under the new guidelines and now is the only meter to have the highest accuracy FDA labeling claim. • These are the new FDA SMBG guidelines going forward. • The self-test Nova Max uses the same multi-well technology that is used in Nova’s hospital glucose meters. The improved accuracy of this technology has taken Nova from 0% to 57% market share in U.S. hospitals versus Roche and Abbott. A similar penetration can happen in the self-test market.

  5. Only glucose meter system cleared underthe new higher accuracy FDA standard One goal of the new FDA standard is to improve the accuracy of current glucose meters used by consumers. Nova Max Multi-Well technology is the only technology that has met the new, higher accuracy FDA standard for SMBG use. Nova Max accuracy was proven in the hands of 350 lay people using multiple test strip lots. Nova Max exceeds the new FDA accuracy standard for lay users with 95% of Nova Max data within ±10% of the laboratory comparator method.

  6. Only glucose meter system cleared underthe new higher accuracy FDA standard • The second goal of the new FDA standard is to provide consumers with a simple, standardized way to evaluate meter accuracy. • Accuracy statistics must be prominently displayed on the product packaging, providing a simple format to compare meter accuracy. This will now be a requirement for all new glucose meter clearances by the FDA.

  7. New FDA standard highlights accuracy as the primary criterion for SMBG clearances Accuracy statistics will be prominently displayed on the product packaging, providing a simple format for comparing SMBG accuracy. This is part of the new FDA standard.

  8. Nova Max brings Nova’s proven hospital technology and outcomes to self-testing Improved insulin dosing1 A Mayo Clinic study compared Nova StatStrip multi-well technology to the laboratory reference method on critically ill patients from six different ICUs1. Patients were receiving intensive insulin therapy/tight glycemic control. Patients in the ICU were taking multiple medications and often had abnormal hematocrit and/or oxygen levels. • StatStrip met stringent CLSI POCT12-A3 guidelines of ±12.5% • StatStrip provided improved insulin dosing versus the Roche Inform meter. 99% of StatStrip’s data points were within the same or one-category dosing as the lab serum results, leading to the same clinical treatment. Simulation models show that SMBG accuracy of ±20% can cause 5-6% probability of hypoglycemia (glucose <70 mg/dL) when used to correct moderately high glucose levels of 200 mg/dL to a nominal level of 100 mg/dL. StatStrip accuracy of ± 10% provides 0% probability of hypoglycemia when used to correct moderately high glucose levels of 200 mg/dL.2 1. Karon B et al. Retrospective Evaluation of the Accuracy of Roche AccuChek Inform and Nova StatStrip Glucose Meters when Used on Critically Ill Patients. DiabetTechnol & Ther2014;11:1-4.2. Breton M, Kovatchev B. Impact of blood Glucose Self-monitoring Errors on Glucose Variability, Risk for Hypoglycemia, and Average Glucose Control in Type 1 Diabetes: an In Silico Study. J Diabetes SciTechnol 2010;3:562-570.

  9. Nova Max brings Nova’s proven hospital technology and outcomes to self-testing Improved glycemic variability and time in target range1 A second Mayo Clinic study showed that their hospital conversion from Roche to Nova StatStrip resulted in improved glycemic variability and time in target range for critically ill patients. For people with T1 diabetes, glucose variability has negative consequences. Increased variability can lead to cycles of overtreatment and both hyper- and hypoglycemia. 1. Karon B, Meeusen J, Bryand S. Impact of Glucose meter Error on Glycemic Variability and Time in Target Range During Glycemic Control After Cardiovascular Sugery. J Diabetes SciTechnol 2015;10(2):336-342.

  10. Nova Max brings Nova’s proven hospital technology and outcomes to self-testing Reduced hypoglycemic events, improved glycemic variability1 A University of California Davis study randomized severely burned patients to receive IIT, targeting a glucose level of 111-151 mg/dLusing both StatStrip and the hospital’s current meter. The trial reported lower glycemic variability, mean insulin rate and frequency of hypoglycemia with StatStrip than with the hospitals Roche meter. 1. Tran NK, Godwin ZR et al. Clinical Impact of Sample Interference on Intensive Insulin Therapy in Severely Burned Patients: A Pilot Study. J Burn Care Res 2014;35:72-29

  11. Nova Max brings Nova’s proven hospital technology and outcomes to self-testing Improved Sensitivity for Detecting Hypoglycemia1 A University of Toronto Hospital for Sick Kids study compared StatStrip and a competitor meter (Roche) to the laboratory reference method in a large population of critically ill neonatal patients. The study reported that StatStrip improved detection of hypoglycemia and critically low glucose results. Because hypoglycemia requires immediate treatment, detection of hypoglycemia is a critical use of SMBG meters. 1. Raizman J et al. Clinical impact of improved point-of-care glucose monitoring in neonatal intensive care using Nova StatStrip: Evidence for improved accuracy, better sensitivity, and reduced test utilization. Clinical Biochemistry 2016;49:879-884.

  12. Nova Max brings Nova’s proven hospital technology and outcomes to self-testing StatStrip’s dramatic reduction in patient adverse events Nearly 57% of hospitals in the U.S. have already converted to StatStrip because it improves outcomes and dramatically reduces the costs of treating adverse events. The FDA requires manufacturers to report hospital adverse events, including patient deaths, caused by their glucose meters. The FDA MAUDE database shows dramatic StatStrip improvement over current glucose meters on hospital patients including the hospitals most critically ill patients. 1. StatStripGlucose Hospital Meter System. MAUDE database. Accessed 7 Nov 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM 2. ACCU-CHEK Inform II Blood Glucose Monitoring Test Strips. MAUDE database. Accessed 7 Nov 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM 3. Assumes 90,000 StatStrip meters in use (57% market share) and 52,000 Inform II meters in use (30% market share). Survey data available upon request

  13. FDA MAUDE databasesummary • Roche Inform II patients are 40 times more likely to experience an adverse event than StatStrip patients. • Nova adverse event rate is 2.5% of the Roche adverse event rate. • For every Roche 100 adverse patient events, Nova had only 2.5, a reduction of 97.5%. • There were 3 patient deaths attributed to the Roche meter, none to the Nova meter. • The same meters will now compete in the SMBG market and will produce the same reductions in adverse events and the costs of treating them.

  14. How LifeScancan market Nova Maxas the premier self-test meter • Nova Max is significantly improved from all other meters in the most important category: FDA labeling accuracy. • Improved accuracy is an FDA priority in the SMBG market. Nova Max and LifeScan can be the leader in marketing to this need. • Nova test strip accuracy has resulted in important improvements in hospital patient outcome and safety and 150 scientific papers have been published that quantify very significant improvements in patient outcome, safety, and patient cost reductions. Using MASA generated studies from our KOLs, LifeScan can show the same clinical benefits to self-test patients and a reduction in patient costs to the insurers. • Nova Max accuracy can have a positive carryover effect on other LifeScan diabetes products. It positions LifeScan as the leader in improving patient outcomes, and lowering costs.

  15. How LifeScancan market Nova Maxas the premier self-test meter • Ketones: Nova Max will also measure ketones • “Patients with type 1 diabetes should test for ketones during acute illness or stress or when blood glucose levels are consistently elevated, during pregnancy, or when any symptoms of ketoacidosis such as nausea, vomiting, or abdominal pain are present.” 1 • DKA is the leading cause of hospitalization and death in children and adolescents with diabetes. Self-monitoring for blood ketone levels can provide the early warning needed to initiate home treatment to avoid trips to the emergency department, hospitalization, and life-threatening DKA.2 • DKA is a large economic burden on the US healthcare system. Based on an annual average of ∼100,000 hospitalizations for DKA in the U.S., with an average cost of $13,000 per patient, the annual hospital cost for patients with DKA exceeds $1 billion per year.3 • Ketone testing is as easy as glucose self-testing. • Nova’s U.S. and European SMBG meters offer ketone testing. Ketone testing accounts for 4% of glucose strip unit sales and 8% of glucose strip revenues. American Diabetes Association, Tests of Gycemia in Diabetes. Diabetes Care 2004;27:S91-03. Bismuth E et al. Pediatr Diabetes 2007;8(S6);24-33 America Diabetes Association. Hyperglycemic Crises in Diabetes. Diabetes Care 2004;27(S1S94-S101

  16. How LifeScancan market Nova Maxas the premier self-test meter • Cholesterol: Nova Max will also measure cholesterol • Nova has developed a self-test cholesterol strip. It is CE marked and Nova’s European SMBG OEM partner will be launching a glucose/ketone/cholesterol meter in September, 2018. However their glucose strip is not Nova Max multi-well technology. • People with diabetes have serious cholesterol problems, which results in a higher risk of cardiovascular disease (CVD) than people without diabetes. For people aged 65 years or older with diabetes, high cholesterol consequences are dramatic. They are: • 2 to 4 times more likely to have heart disease or stroke • 68% die from CVD • 16% die of stroke • 84% of people with diabetes die from cholesterol related disease, not from direct glucose issues. • Cholesterol management is an essential component of cardiovascular disease risk management for people with diabetes. Glucose control alone is not sufficient to manage the risk of cardiovascular disease. • A combined glucose/cholesterol meter will enhance patient adherence to a cholesterol reducing program. Cholesterol testing is as easy a glucose testing. Cholesterol results are available in 30 seconds from 1.6 uL of capillary blood.

  17. How LifeScancan market Nova Maxas the premier self-test meter • It will reduce patient adverse events and costs for insurers similar to the hospital’s experience in reducing adverse events and costs. • Patients and physicians will benefit from ketone and cholesterol information in addition to accurate glucose results. • Nova Max could be offered with a higher patient copay compared to other LifeScan offerings and would still be extraordinarily popular • An educational, scientific marketing program with studies would be the most effective way to uniquely position this product and its patient benefits.

  18. Nova BiomedicalLancing Strip and Meter

  19. Nova All-in-One Lancing Strip and Meter Combines sterile safety lancet and test strip into a single component Only two components are needed to perform testing: test strip and meter Overall testing steps are reduced from 28 to 9 Overall testing time reduced from 1 minute 36 seconds to 42 seconds Ketone and Cholesterol can be measured with the same meter Data download port Test strip ejector

  20. Product Details • Integrates lancing and measuring functions into one disposable • Safety lancet automatically retracts into strip/lancet/carrier assembly after use • No increase in meter size despite adding lancer functions • Strip ejector

  21. Meter Details • New sterile safety lancet is incorporated into each strip • Sterile lancet is exposed only when fired to create the blood drop. It is then immediately retracted to a non-exposed position.

  22. Two in One Glucose Test Strip Action • A new sterile lancet is integrated into each test strip • The sterile lancet tab is removed just before use so lancet sterility is maintained. • The meter lancing mechanism fires the lancet into the fingertip • An internal spring automatically retracts the lancet after the finger stick • The contaminated sharp is then safely stored in the two-in-one strip assembly.

  23. Single Use Self Testing Strip and Safety Lancet

  24. Fastest, Simplest POC Glucose Testing Testing steps are reduced from 28 to 10. Testing time is reduced from 1 minute, 36 seconds to 42 seconds

  25. Nova Uno All-in-One Lancing Strip and Meter Size comparison to non-lancing meters Accu Chek Nano 2.7L x 1.4W x 0.8D Accu Chek Advantage 3.3L x 2.2W x 0.8D Nova Uno 3.8L x 2.2W x 1.1D Accu Chek Aviva 3.7L x 2.1W x 0.9D OneTouch Ultra 2 3.1L x 2.3W x 0.9D OneTouch Ultra Mini 4.2L x 1.3W x 0.7D Abbott Freestyle Freedom Lite 3.3L x 2.0W x 0.6D Abbott Freestyle Lite 2.9L x 1.6W x 0.7D Dimensions in inches

  26. Measures Blood Ketones With the Same Meter The American Diabetes Association and European Society for Pediatric Endocrinology recommend blood ketone testing whenever glucose exceeds 250 mg/dL (14 mmol/L). Measures blood beta-hydroxybutyrate, the preferred ketone for diagnosis of ketoacidosis Blood ketone is more accurate than urine ketone testing. Blood ketone testing is performed using a separate ketone test strip lancet. The test procedure is as simple as glucose testing.

  27. Measures Blood CholesterolWith the Same Meter • People with diabetes have serious cholesterol problems, which results in a higher risk of cardiovascular disease (CVD) than people without diabetes. For people aged 65 years or older with diabetes, high cholesterol risks are dramatic, they are: • 68% die from CVD • 12 to 4 times more likely to have heart disease or stroke • 6% die of stroke • In total 84% of people with diabetes die from cholesterol related disease, not from direct glucose issues. • Cholesterol is critical and controllable risk factor for people with diabetes. • Glycemic control alone is not sufficient to eliminate the increased risk of CVD associated with diabetes. • Cholesterol management is essential in the care of people with diabetes.

More Related