C8 MediSensors Gains CE Mark Approval for the C8 MediSensors Optical Glucose Monitor(TM) System for People with Diabetes

SAN JOSE, California, October 25, 2012 /PRNewswire/ --

A new non-invasive continuous glucose monitor is approved for marketing in Europe

C8 MediSensors, Inc. (http://www.c8medisensors.com) has today announced it received CE Mark approval for its Optical Glucose Monitor System, allowing the device, a new non-invasive continuous glucose monitor (nCGM), to be marketed in Europe.

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The comprehensive, 10-year Diabetes Control and Complications Trial (DCCT) clearly demonstrated that individuals with type 1 diabetes who kept blood glucose levels as close to normal as possible for as long as possible had less chance of developing disease-related complications. The DCCT found that the risk of eye disease was reduced by 76%, kidney disease by 50% and nerve disease by 60%.[1]Since that time, other studies have confirmed the importance of tight glycaemic control with minimal glucose excursions in reducing disease-related complications not only in type 1 diabetes, but also in type 2.[2-6] In addition, a large number of studies have shown that continuous glucose monitors (CGM) can improve glycaemic control with reduced risk of hypoglycaemia.[7-19]

CGMs are adjunct devices that are intended to complement finger stick blood glucose tests. Traditional CGMs rely on a needle sensor inserted under the skin, which can cause pain or discomfort, and pose a risk of infection.[20] In contrast, the C8 MediSensors Optical Glucose Monitor System harnesses the power of light to measure glucose levels. Using Raman spectroscopy, a beam of light is shone into the skin and the resulting vibrations of glucose molecules are measured to give a glucose reading; all achieved via a small, pain-free portable monitor, discreetly worn under clothes against the skin.  

For added convenience these readings are stored and sent wirelessly to the user's smartphone for glucose readings at a glance, providing the wearer with a continuous picture of glucose dynamics throughout the day. A good understanding of glucose levels is invaluable in managing diabetes and improving patient outcomes.[1]In clinical studies, the C8 MediSensors monitor was found to have accuracy comparable to earlier versions of invasive CGMs when those systems were first introduced, but with less pain and less risk of infection.

"C8 MediSensors was co-founded by a father trying to help his son living with diabetes, and as a company, we remain dedicated to helping those with the disease," said Paul Zygielbaum, CEO of C8 MediSensors. "CE Mark approval is a landmark step for this unique technology. Our team is hugely excited to be working to make nCGM and the Optical Glucose Monitor System available throughout Europe."

The C8 MediSensors Optical Glucose Monitor System will initially be available for purchase online via the C8 MediSensors website, http://www.c8medisensors.com.

The C8 MediSensors Optical Glucose Monitor System is an adjunct device.  It is contraindicated in pregnancy and for those under 18 years of age, as well as in individuals with very light or very dark skin tones, peripheral vascular disease or individuals who smoke.

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Notes to editors:

About C8 MediSensors

C8 MediSensors is the leader in non-invasive continuous glucose monitoring. Headquartered in San Jose CA, C8 MediSensors' breakthrough patent-protected technology gives people with diabetes a continuous view of their glucose levels, without the pain, inconvenience and high cost of invasive continuous glucose monitoring. Visit http://www.c8medisensors.com.

Additional background information on 'Diabetes and continuous glucose monitoring' and 'C8 MediSensors and the Optical Glucose Monitor' are available from the European media contacts below.

This document contains forward-looking statements. Any statements contained in this document that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the company's anticipated product sales and financing needs. These forward-looking statements are based upon the company's current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with market conditions, customer demand for the product, and risks and uncertainties associated with the company's business and finances in general. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. The company does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.

References

  1. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329(14):977-86
  2. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352(9131):837-53
  3. Monnier L, Colette C, Boegner C, et al. Continuous glucose monitoring in patients with type 2 diabetes: Why? When? Whom? Diabetes Metab 2007;33(4):247-52
  4. Monnier L, Mas E, Ginet C, et al. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA 2006;295(14):1681-7
  5. Hirsch IB, Abelseth J, Bode BW, et al. Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study. Diabetes Technol Ther 2008;10(5):377-83
  6. Ceriello A. The glucose triad and its role in comprehensive glycaemic control: current status, future management. Int J Clin Pract 2010;64(12):1705-11
  7. Beck RW, Buckingham B, Miller K, et al. Factors predictive of use and of benefit from continuous glucose monitoring in type 1 diabetes. Diabetes Care 2009;32(11):1947-53
  8. Anderson J, Effect on glycemic control by short- and long-term use of continuous glucose monitoring in clinical practice. J Diabetes Sci Technol 2011;5(6):1472-8
  9. Bailey TS, Zisser HC, Garg SK. Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technol Ther 2007;9(3):203-10
  10. Chico A, Vidal-Ríos P, Subirà M, Novials A. The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. Diabetes Care 2003;26(4):1153-7
  11. Garg S, Jovanovic L. Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor. Diabetes Care 2006;29(12):2644-9
  12. Garg S, Zisser H, Schwartz S, et al. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care 2006;29(1):44-50
  13. Kaufman FR, Gibson LC, Halvorson M, et al. A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care 2001;24(12):2030-4
  14. Garg SK, Kelly WC, Voelmle MK, et al. Continuous home monitoring of glucose: improved glycemic control with real life use of continuous glucose sensors in adult subjects with type 1 diabetes. Diabetes Care 2007;30(12):3023-5
  15. Chase HP, Beck RW, Xing D, et al. Continuous glucose monitoring in youth with type 1 diabetes: 12-month follow-up of the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Technol Ther 2010;12(7):507-15
  16. Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics 2003;111(5 Pt 1):933-8
  17. De Block C, Manuel-y-Keenoy B, Van Gaal L. A review of current evidence with continuous glucose monitoring in patients with diabetes. J Diabetes Sci Technol 2008;2(4):718-27
  18. Vazeou A. Continuous blood glucose monitoring in diabetes treatment. Diabetes Res Clin Pract 2011;93 (Suppl.1):S125-30
  19. Harman-Boehm I. Continuous glucose monitoring in type 2 diabetes. Diabetes Res Clin Pract 2008;82 (Suppl.2):S118-21
  20. Vaddiraju et al. Technologies for Continuous Glucose Monitoring: Current Problems and Future Promises. J Diabetes Sci Technol 2010;4(6):1540-1562


SOURCE C8 MediSensors




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