Medtronic’s Diabetes Innovations

Lee Sang Soo BA, Reimbursement Manager, Medtronic Korea Co., Ltd. Seoul, South Korea  

The first therapy in the history of diabetes management to integrate an insulin pump with real-time continuous glucose monitoring(CGM) 

Prevalence and cost of diabetes  [1], [2], [3], [4], [5]

Diabetes is a serious condition for the individual and on the global scale its rapidly increasing prevalence is a significant global health risk. The disease affects more than 230 million people worldwide and is estimated to affect 350 million by 2025. The epidemic nature of diabetes continues to affect ever-increasing numbers of people around the world while public awareness remains still low.

According to the International Diabetes Federation (IDF), in 2003, it was estimated that there were around 194 million adult diabetes populations in the IDF Regions. Also, it was estimated that 5.1% (in the age bracket 20-79) of people in all IDF member countries have diabetes. And the five countries with the largest numbers of people with diabetes were India (35.5 million), China (23.8 million), the United States (16 million), Russia (9.7 million) and Japan (6.7 million).

The IDF Diabetes Atlas second edition reconfirms the fact that type 2 diabetes constitutes about 85% to 95% of all diabetes cases in developed countries and accounts for an even higher percentage in developing countries.

Also, it is estimated that approximately 4.9 million people in all age groups have type 1 diabetes, amounting to 0.09% of the world's population. The estimated prevalence of type 1 diabetes is highest in the North American Region (0.25%), followed by the European Region (0.19%).

The World Health Organization (WHO) estimates that 2.5 to 15% of annual health budgets are spent on diabetes-related illnesses. A person with diabetes incurs medical costs that are two to five times higher than those of a person without diabetes. This is due to more frequent medical visits, purchase of supplies and medication, and the higher likelihood of being admitted to a hospital  ^[3]

And there is conclusive evidence that good control of blood glucose levels can substantially reduce the risk of developing complications and slow their progression in all types of diabetes. The management of high blood pressure and raised blood lipids (fats) is equally important. In all societies, better control of these parameters would contribute to a substantial improvement of quality of life.

Current standards for assessing glucose control include A1C tests and fingerstick measurements, yet both have limitations. An A1C test, which measures glucose control over a three-month period, is important for long-term management, but it is only an average and does not reveal day-to-day glucose fluctuations that can damage the body. In turn, fingerstick measurements only reveal a glucose value at a single moment in time. As a result, patients are unable to detect approximately 60 percent of low glucose (hypoglycemia) events, and have difficulty assessing glucose fluctuations while they sleep.

Insulin pump therapy is proven to provide greater control than multiple daily injections (MDI) with long-acting insulin[6],[7],[8]. Research also proves that continuous glucose monitoring helps guide therapy adjustments and reduces A1C levels more effectively in fingerstick alone[9],[10],[11].

About Insulin Pump Therapy

Insulin pump is a small pager-size medical device that delivers insulin around the clock, much like a healthy pancreas. It is the most advanced method for precise and adjustable insulin delivery. Unlike injection therapy, insulin pump users can program their insulin pump to deliver insulin at varying rates to meet their changing insulin needs throughout the day and night. In addition, insulin can be delivered on demand at the touch of a few buttons. Many patients experience improved quality of life with insulin pump therapy, ridding themselves of multiple injections, strict meal schedules and rigid sleep patterns that are associated with injection therapy. 

In the report of “Future Developments in insulin pump therapy”, the use of multiple daily injections (MDI) began increasing in 2001 at Children’s Hospital Los Angeles. A common barrier for MDI therapy is the burden of multiple injections each day, and this may perplex school-aged children since they need to leave the classroom and go someplace for insulin injections.  

An advantage that the pump provides for its users, when compared with MDI, is that the ability to fine-tune insulin delivery and the flexibility to start or stop insulin delivery on demand with relative discretion. Insulin pump is also less time-consuming and results in less missed class time for younger children[12]. 

For the first time in history of diabetes management, Medtronic integrates an insulin pump with REAL-Time continuous glucose monitoring(CGM).

The Minimed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System is the first of its kind in the world and represents a breakthrough in diabetes management. 

This new technology helps patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications, including coma, blindness, kidney failure, amputation, impotence, and heart disease. 

Paradigm REAL-Time Insulin Pump System
The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring(CGM) System, and a MiniMed Paradigm insulin pump.

The REAL-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays to 288 readings a day – nearly 100 times more information than three daily fingersticks. 

REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick. The REAL-Time CGM System component is indicated for any patient 18 years of age or older, and insulin pump therapy for all patients requiring insulin.  

The rational for this device is that the more frequently you measure the glucose level, the more precisely you can understand your daily glucose fluctuations without the inconvenience of frequent needle sticks. Glucose readings from the CGMS^® correlate well with blood glucose levels and with A1C levels. The author's group12 has reported that the CGMS^® is a useful tool in diagnosing asymptomatic nocturnal hypoglycemia[13] and in improving clinical care in children (Fig 3)[14].

Other studies have also reported that the CGMS^® is effective in lowering A1C levels (Fig 4 and 5)[15],[16], reducing hypoglycemic events (Fig 6),[17] and detecting otherwise missed asymptomatic hypoglycemia (Fig 7)[17] ,[18]. CGMS^® uses alarm system to offer the ability to monitor blood glucose readings, which will signal its users when glucose levels reach high or low glucose limits preset by clinical professional, in order to prevent significant hypoglycemic events. 

According to the results presented at the ADA Scientific Meeting in 2004, the study showed that the sensor-augmented insulin pump provided real-time sensor glucose trends that correlated well with blood glucose readings and was useful in managing glycemic excursions. It was helpful in educating patients through insight and understanding. In addition, the sensor-augmented insulin pump improved glycemic control and reduced the development of hypoglycemia.

The patients using sensor-augmented insulin pumps tolerated well with minor complaints about tapes and alarms. This new insulin pump lowered A1C levels and reduced hypoglycemic episodes in its users, providing patients and health care team members with insight into glycemic patterns, which facilitated treatment changes.

All things considered, the sensor-augmented insulin pump can offer real-time information for diabetes management, as well as feedback for carbohydrate counting and adjustments for physical activity. Based on the historical data from the insulin pump downloads, pump setting can be adjusted and the insulin-to-carbohydrate ratio as well as insulin sensitivity factors can be calculated, hence the treatment can be optimized¹².

About Medtronic Diabetes
Medtronic Diabetes (www.minimed.com) is the world leader in insulin pump therapy and continuous glucose monitoring. The company’s products include external insulin pumps, continuous glucose monitoring systems and related disposable products.

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.

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