Diabetes patients manage disease better with real-time continuous glucose monitor, study shows

UK investigator says Medtronic's Guardian® RT system could help reduce glucose level fluctuations

BOURNEMOUTH , England - 16 June 2005 - Results of an international pilot study involving a UK diabetes clinic shows that real-time glucose monitoring helps patients achieve tighter control of their blood glucose levels, a key to managing the disease and minimising long-term complications.

The Type 1 diabetes patients who took part in the pilot study used Medtronic's new Guardian® RT Continuous Glucose Monitoring System to check their blood-glucose levels throughout the day and night. The system is designed to help patients reduce erratic blood glucose fluctuations that can result in diabetes-related complications, including coma, blindness, kidney failure, amputation, impotence and heart disease.

Dr David Kerr, Consultant Diabetologist from the Royal Bournemouth Hospital who participated in the pilot study, commented: "I am very excited by these findings, which suggest that the Guardian RT System could be highly beneficial in helping to reduce glucose level fluctuations and help diabetes patients make more informed treatment decisions, and on a more proactive basis, compared to random fingerstick measurements that patients rely on today. In addition, our clinic has noticed that patients using real-time readings have more confidence in managing their disease - particularly at night, which is often a critical time for patients who struggle to manage hypoglycaemia".

During the 10-day pilot study, all 16 participating patients responded to glucose values as well as high and low alerts displayed on the screen of a Guardian RT System to make proactive therapy decisions (following a confirmatory finger stick measurement) for improved diabetes management. Ninety-four per cent of the study participants actively used the real-time glucose values and/or high or low glucose alerts to control glucose fluctuations; 75 per cent adjusted their insulin delivery; 63 per cent changed their diet; and 31 percent made lifestyle changes after gleaning insights from real-time continuous glucose monitoring (CGM).

In addition, 81 per cent of patients reported greater satisfaction with their blood glucose control when using the Guardian RT system. No severe hypoglycaemic (low blood glucose level) or hyperglycaemic (high blood glucose level) events were reported. 

Results of the pilot study, titled "First Experience Using The Guardian RT Continuous Glucose Monitoring With Real-Time Values and Alerts in Type 1 Diabetes Mellitus Patients; Results of a Pilot Study", were presented this week at the 65th Annual Scientific Sessions of the American Diabetes Association in San Diego (Abstract Number: 393-P). 

Results of the pilot study are preliminary, and no definitive conclusions can be made without confirmation of a larger study.  A randomised, controlled, multi-centre study is underway using the Guardian RT System in 162 diabetes patients in Germany , France , Sweden , Italy , the United Kingdom , Slovenia and Israel . Dr Kerr's diabetes clinic at the Royal Bournemouth is involved.

The goal of this larger study is to achieve a reduction in A1C levels of 0.5 per cent or more (an A1C test measures blood glucose control over a three-month period).  The study also will evaluate the number and duration of high and low blood glucose fluctuations, average daily blood glucose, quality of life and the health economic impact associated with improved glycaemic control. Results are expected to be available later this summer.

The Guardian RT System is designed to use a subcutaneous glucose sensor, which records as many as 288 glucose readings per day - providing nearly 100 times more information than three daily fingerstick readings provide. The continuous glucose sensor is a tiny electrode that is inserted under the skin using the Sen-Serter®, a small device that makes sensor insertion easy. The sensor measures glucose in the interstitial fluid found between the body's cells, and is typically discarded and replaced after three days of use.

Glucose measurements obtained by the sensor are relayed every five minutes from a transmitter to the Guardian RT's monitor, which displays the glucose value on its screen. In addition, alarm thresholds can be preset to alert patients when glucose levels become too high or too low. The alarm feature is designed to provide added assurance to patients for managing erratic glucose patterns.

Medtronic anticipates real-time continuous glucose readings to be a more advanced method for assessing glucose control compared to today's standards of A1C tests and fingerstick measurements. An A1C test is only an average - it does not reveal day-to-day glucose fluctuations that can cause short and long-term health complications.

Similarly, fingerstick measurements are limited since they only reveal a glucose value at a single moment in time. Patients using fingerstick measurements are unable to detect approximately 60 per cent of hypoglycaemia events and have difficulty assessing blood glucose fluctuations while they sleep. In contrast, the Guardian RT system is designed to provide real-time glucose readings throughout the day and night, allowing patients to understand how fast, and in what direction, their glucose levels are heading.

By discovering how diet, exercise, medication and lifestyle affect their glucose levels, patients can make more informed treatment decisions to improve their diabetes management. The Guardian RT System is designed so that patients can also download information to a computer and print reports highlighting their glucose patterns for further analysis and discussion with their healthcare providers.

Diabetes is reaching epidemic proportions worldwide. According to the International Diabetes Federation's latest figures, approximately 194 million adults have diabetes worldwide, and this number is expected to reach 333 million by the year 2025. An estimated 1.8 million people in the UK have diabetes, with approximately 1 million more undiagnosed according to a report published in October 2004 by Diabetes UK .

Medtronic MiniMed (www.minimed.com) is the world leader in insulin pump therapy and continuous glucose monitoring. The division's products include external insulin pumps, related disposable products, and a continuous glucose monitoring system.

Founded in 1949, Medtronic is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. UK operations, based in Watford since 1987, began in 1972. More information on the company can be found online at www.medtronic.co.uk.

  (9/7/05)