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Medtronic Media Contacts:
Jon Pike, Public and Media Relations , +44 (0)7825 889 607
Rebecca Fancini, Public and Media Relations , +44 1923 212 213

New insulin device to protect diabetes patients against dangers of hypoglycaemia

British patients first in world to take ‘step closer to artificial pancreas’


LONDON – 2 June 2009 – Diabetes patients in the UK and Ireland will be the first in the world to use a new technology which mimics key elements of the human pancreas.  This new device can automatically suspend insulin delivery to reduce the severity of low blood sugar, a dangerous and often frequent occurrence in diabetes management. 

Medtronic’s new Paradigm® VeoTM System combines insulin pump therapy and continuous glucose monitoring with a unique new capability to automatically suspend insulin delivery temporarily if glucose levels become too low, protecting against the risk of low blood sugar (also known as hypoglycaemia) even when a person is asleep or unable to react.

Hypoglycaemia is common and can be one of the most frightening aspects of living with type 1 diabetes.  If left untreated, hypoglycaemia can cause loss of unconsciousness, seizure, coma or even death.1 Experts estimate that the annual direct cost of treating severe hypoglycaemia could be in excess of £13 million in the UK.2 

Research indicates that on average a person with diabetes will experience more than one low blood sugar event every fortnight. Additionally, each year nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycaemia, which requires urgent treatment by healthcare professionals.2

A third of diabetes patients suffer from hypoglycaemia while asleep, which may impair their ability to recognise or act to prevent a serious episode.3 Around 33% of diabetes-related deaths are as a result of acute complications such as hypoglycaemia.4 There are currently more than 2.5 million people with diabetes in the UK, and it is estimated that 350,000 people have type 1 diabetes.5,6

The Paradigm Veo System includes an insulin pump with continuous glucose monitoring (provided by means of a separate sensor and transmitter). The patient uses readings from the monitor in conjunction with occasional confirmatory fingerstick measurements to understand their current glucose level, and program the insulin pump to deliver the appropriate amount of insulin. Insulin combats high blood sugar, a key cause of heart disease and other long-term complications in type 1 diabetes.1 However, if data transmitted from the sensor show that the patient’s glucose levels have dropped below a defined threshold, the insulin pump automatically suspends insulin delivery for up to two hours.  This helps to protect against potentially dangerous hypoglycaemic events. 

While some patients can experience ‘warning signs’ before a hypoglycaemic event (such as feeling shaky, sweating, tingling in the lips, going pale, heart pounding, confusion and irritability), others do not experience any warning signs at all.

Mrs. Angela Wise is a type 1 diabetes patient who trialled the new Paradigm Veo System prior to launch.  She comments: “Injecting insulin to combat diabetes is like walking a tight rope.  I know keeping my blood sugar at the right level is essential to prevent a heart attack or going blind.  I have a problem with hypoglycaemic events in that recently I’ve lost my warning signs, so the new device is a little package of peace of mind. I can now relax without fear of a hypo while keeping my diabetes under better control.”

Dr Peter Hammond, Consultant Diabetologist, Harrogate Hospital, comments: "This latest technology is a significant breakthrough which will help people with diabetes to control their condition. In order to reduce the long-term risk of diabetes-related complications, which can cause blindness, kidney failure and heart attacks, patients have to try and aggressively lower their blood glucose levels to get them as near normal as possible. Doing this significantly increases their risk of severe hypoglycaemia, which can render a patient unconscious—and if recurrent—can have very serious consequences. Paradigm Veo alerts the patient if their glucose levels drop too low, and stops them getting more insulin if they don’t respond to the alert. Having this safety feature takes us a step closer to an artificial pancreas, and allows patients to get greater control over their blood glucose levels. This will have a huge impact on the patient’s quality of life, giving them greater flexibility and reducing anxiety, and protecting them against the long-term health complications of diabetes."

Commenting on the importance of this development, Karen Addington, Chief Executive of Juvenile Diabetes Research Foundation, the world’s leading charitable funder of type 1 diabetes research said: "There are about 350,000 people in the UK living with type 1 diabetes, of whom 25,000 are children.  Achieving good blood glucose control can be difficult but significantly reduces the risk of long term complications, so access to developments in treatments and technology, such as this, are vital to keep people with type 1 diabetes as healthy as possible, until we find the cure."

Recent positive guidance from the National Institute for Health and Clinical Excellence (NICE) (www.nice.org.uk/Guidance/TA151) indicates that devices such as the Paradigm Veo can be funded by the NHS for certain patients with type 1 diabetes.

Paradigm® VeoTM  System is produced by Medtronic. More information is available at: www.medtronic-diabetes.co.uk   

Notes to Editors:
• Paradigm Veo System includes an insulin pump, a glucose sensor and a transmitter, integrating Continuous Subcutaneous Insulin Infusion (CSII) with Continuous Glucose Monitoring (CGM).
• Patients can use the Paradigm Veo insulin pump to deliver insulin without the glucose sensor and transmitter.
• Paradigm Veo System comes in five colour options with a range of accessories and adhesive SKINs to cover the insulin pump which allow patients to personalise their device.

About the Diabetes Business at Medtronic
The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
More information is available at: www.medtronic.co.uk

Any statements made about the anticipated regulatory review or approval are forward-looking statements and subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 24. 2009.  Actual results may differ materially from anticipated results.

References
1. Diabetes UK:
www.diabetes.org.uk/en/Guide-to-diabetes/Complications/Short_term_complications/Hypoglycaemia/ (Accessed 23rd April 2009)
2. Leese GP, Wang J et al. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes. Diabetes Care 26:1176-1180, 2003.
3. Pramming S, Thorsteinsson B et al. Nocturnal hypoglycaemia in patients receiving conventional treatment with insulin. British Medical Journal 291(1985):376-379
4. Orchard TJ. International evaluation of cause-specific mortality and IDDM. Diabetes Care 14:55-60, 1990
5. Diabetes UK:
www.diabetes.org.uk/Guide-to-diabetes/Introduction-to-diabetes/What_is_diabetes/ (accessed 23rd April 2009)
6. Juvenile Diabetes Research Foundation:
www.jdrf.org.uk/page.asp?section=25&sectionTitle=About+Type+1+Diabetes (Accessed 23rd April 2009)
 
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