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Patient Stories

Click Here to see the New Idea article
Marcia’s secret HEARTACHE
Published in New Idea, January 29, 2005

 
Click Here to see the article
Her mum had it, she has it and now Marcia fears diabetes is on the cards for Deni
By Jacqui Lang


Towards a cure

A diabetes patient today can look to the future and see alternatives that will bring them very close to a cure. Ten years ago it was difficult, 20 years ago it was a dream, 50 years ago there was no hope. Brace yourself, because advances in diabetes management are no longer just a dream – they’re a reality.

Any patient with type 1 diabetes can appreciate the demands it takes to manage the disease, so it’s encouraging to report, on the eve of the Australian Diabetes Week 2005, that recent scientific and technological advancements point to a brighter and more independent future for patients.

Diabetes is recognised as a serious illness throughout the world and research is always underway to help patients improve their diabetes management. Biological research addresses the potential to improve transplant techniques, as well as exploring vaccines and stem cell research. While it is making significant headway, is not yet sophisticated enough to be seen as a realistic option for most patients. Research using mechanical devices to improve diabetes management, such as devices that more closely mimic the function of a healthy pancreas, are also reaching new heights.

“We’re in a renaissance period of science and development (for diabetes),” observes Dr Fergus Cameron, Deputy Director of Endocrinology and Director of Diabetes at the Royal Children’s Hospital in Melbourne. “Things are happening now that 10 years ago, 20 years ago, were not even conceived of. It’s a rapidly developing technological area, and a very exciting time to be working in the field.”

Exciting treatments now available
Two of the most exciting developments currently available are continuous glucose monitoring and insulin pump therapy. “These are major steps forward in the treatment of diabetes,” says Dr Cameron.

Unlike fingerstick measurements that capture a single snapshot like using a digital camera, continuous glucose monitoring is like watching a movie. It provides a complete picture of patients’ glucose activity around the clock.

Insulin pumps are the most advanced method of precise and adjustable insulin delivery. “Smart pumps” recommend insulin dosages, simplifying diabetes management for patients. They also keep track of how much insulin is active in the body, helping patients reduce the number of low blood sugar (hypoglycaemia) episodes they experience. Hypoglycaemia is one of the biggest problems for patients with diabetes.

Insulin pumps
Patients using traditional insulin injections can have difficulty maintaining near-normal glucose levels. As a result, they experience much more hypoglycaemia, particularly when trying to maintain HbA1C levels below the recommended guidelines of seven percent.

The fact that an insulin pump delivers precise amounts of insulin around the clock can provide better metabolic control with less of a risk of hypoglycaemia.

Pump technology started in the late 1960s with a pump the size of a backpack produced by American Dr Arnold Kadish. The sheer size of the Kadish device made it impractical. In the 1980s dozens of companies tried to create an effective insulin pump, yet many failed. Today, one company has been serving customers continuously for more than 20 years – Medtronic Diabetes. This company has led the industry with new insulin pump features and is leading the development of an artificial pancreas.

In Australia, around 2000 patients have converted from injections to pump therapy and, worldwide, 350,000 are estimated to use this important therapy. Patients, including children with diabetes, and their clinicians, are rapidly recognising the advantages of insulin pump therapy.

Many recent studies have shown that pumps are both safe and effective for toddlers and young children, so long as the parents are highly motivated.

“We’ve got about 50 kids on pumps (in our clinic), and a very long waiting list,” says Dr Cameron.

Light weight and non-intrusive, an external insulin pump can be easily worn on a patient’s belt or carried in their pocket. Insulin is stored in a reservoir in the pump and delivered to the body via an infusion set, which is easily inserted by the patient under the skin (into the subcutaneous tissue). Infusion sets are typically replaced every two to three days. Importantly, the pump is able to provide a wide range of insulin delivery options and includes features such as memory and alarms.

How do insulin pumps work?
Insulin pumps deliver a baseline amount of insulin around the clock (called a basal rate) which can be programmed to deliver varying amounts of insulin to match activity levels. They are personalised for each user. Extra insulin (called a bolus dosage) can be delivered to match food intake.

“An insulin pump offers the motivated diabetic the best opportunity to optimise their glycaemic control at present,” says Endocrinologist Dr David O’Neal from the Department of Medicine at St Vincent’s Hospital, Melbourne.

Rather than injecting insulin multiple times a day, pump users simply insert an infusion set once every two-to-three days and deliver insulin at the touch of a few buttons. Insulin pumps use only rapid-acting insulin, which is absorbed very predictably by the body and this helps patients improve their blood sugar control. Unfortunately, with syringe therapy, insulin absorption is much more unpredictable. “The way a pump works one day is the way it will work the next day,” says Dr Cameron. “With the traditional multiple daily injections, insulin absorption can vary enormously day-to-day. Because (the pump) is a much more predictable delivery device, parents (of diabetic children) are much more comfortable.”

Peace of mind
While successful pump use requires the patient to responsibly self-manage their condition, they are able to enjoy greater freedom in the timing of their meals, work, school, sleep and physical activity compared to daily insulin injections. The risk of hypoglycaemia is also significantly reduced.

“The greatest fear a parent has for their diabetic child is the risk of hypoglycaemia, particularly at night. Some parents never have a complete night’s sleep because they’re up several times a night checking their kids’ blood sugar levels,” says Dr Cameron. “There’s no zero risk (of hypoglycaemia), but with an insulin pump it’s reduced.”

In addition to reducing diabetes-related complications, a notable advantage of pump therapy is that patients feel better – their moods are more stable and this helps with quality of life.

“It’s not known if depression is due to all this hypoglycaemia nibbling away at your brain, or if living with constant concerns cause depression,” says Dr Cameron. “But preliminary data suggests that if patients reduce the swings in blood sugar levels, it can have a positive impact on temperament.”

Continuous blood glucose monitoring
Blood glucose monitoring has also seen rapid improvement in the past five years, again due to the commitment Medtronic Diabetes has made to effective diabetes management. Following the primitive and largely subjective method of urine tasting to estimate glucose levels practised in the 1700s, the development of urine strips in the 1900s was a welcome breakthrough. In the 1970s blood glucose testing reached new heights with the introduction of meters, which could read levels from a single finger prick. The creation of physician-use continuous glucose monitoring in 1999 also revolutionised diabetes management. This exposes unhealthy glucose fluctuations by taking as many as 864 glucose measurements over a 3-day period.

Medtronic is developing a system that integrates continuous glucose monitoring with an external insulin pump. It is expected to be the most highly developed diabetes management device ever seen.

“We are testing a future system that is designed to display real-time glucose readings and trend graphs, which is expected to provide patients with much more information than they’ve ever had before,” explains Gustavo Gurgulino, Director for Medtronic Diabetes Asia Pacific. “The system is also smart – it is designed to recommend an insulin dosage to patients so that they don’t have to do the complex diabetes math. Patients will need to manually confirm the recommendation prior to receiving insulin, but it’s a quantum leap in today’s technology.” This integrated system is a major step toward the creation of an “external” artificial pancreas, yet it does not replace fingerstick measurements.

Many doctors around the world are eagerly anticipating this device. “Patients will have a lot more information on how to organise their insulin delivery,” says Dr Cameron. “Instead of knowing what their blood sugar level is at four points through the day, they can know their blood sugar levels at 12 points every hour.” This important feature should allow users to see their glucose trends at any given time.

The dream of an artificial pancreas
The advancements in diabetes management in the past two decades have been phenomenal. It was only in 1983 that Medtronic Diabetes launched its first insulin pump and it has been working on its vision of creating an artificial pancreas ever since. Despite the sophisticated products currently available, the good news doesn’t stop there. Medtronic is testing advanced mathematical algorithms, which could be considered the “brains” of a future artificial pancreas.

Dr. O’Neal is optimistic about the potential for closed-loop insulin delivery to optimise the lifestyle of patients with diabetes: “Advances in insulin delivery technology holds the most promise for further improving our management of patients,” he says. “A device that not only acts as a delivery system but also monitors glucose levels, would, if the loop was closed, control basal insulin delivery with the patient remaining in control of the insulin bolus. This approach would potentially improve nocturnal glycaemic control, minimising both hyper and hypoglycaemic excursions.”

Medtronic Diabetes is also testing implantable insulin pumps in clinical trials. “More than 350 people are using implantable pumps under clinical protocol today. With this system, insulin is refilled on average every 90 days,” says Mr Gurgulino. “Medtronic also expects to create a fully implantable artificial pancreas using this technology and its implantable glucose sensor, but this program is much further in the future.”

Biological advances
Biologically, the most promising advancement for patients with diabetes in recent times has been the refinement of islet cell transplantation. Successful transplantation of islet cells, responsible for insulin production in the pancreas, was elevated from eight per cent to around 80 per cent following the Edmonton Protocol in 2000, thanks to technique improvements resulting in insulin-delivery free patients.

It has since been realised that several years following surgery, the transplant success rate declines considerably. Patients can elect repeat surgery, but with a shortage of supply of donor pancreases, in the five years following the Edmonton Protocol, only a few hundred patients with diabetes around the world have received this treatment. Islet cells are extremely delicate and the current technique requires multiple pancreases to provide sufficient islet cells to achieve success.

While scientists are working on combating the islet cell supply shortage by developing methods of harvesting islets using just one pancreas and examining stem cell options, several obstacles remain before islet transplantation can be considered a practical option for diabetic patients. Work continues in this area, yet progress in mechanical developments represents the most promising option for patients with diabetes at this stage.

“The big thing [in the market] that we’re using is the insulin pump, and we’re using it in large numbers of patients,” says Dr Cameron.

Close to a cure?
Although we can still only speculate about how long it will be before a cure for diabetes is found, in terms of identifying those susceptible to diabetes, preventing diabetes and stopping it once it has developed, the current outlook for patients is far from grim.

“The ultimate cure is whatever it takes to give you perfect blood sugar control that requires no input because it’s all automated,” says Dr Cameron. “Whether that’s biological or mechanical, it remains to be seen, but it’s whatever allows you to have a more normal lifestyle.”

Mr Gurgulino is optimistic about the future for patients with diabetes. “Insulin pumps allow patients to improve their blood sugar control in order to live longer, healthier lives, with fewer diabetes-related complications,” he says. “A patient today can look to the future and see alternatives that will bring them very close to a cure. Ten years ago it was difficult, 20 years ago it was a dream, 50 years ago there was no hope.

“The pace of innovation in medical devices is accelerating and much of the innovation for the intensive treatment of diabetes is born at our company,” notes Mr Gurgulino. “We are committed to introducing clinically advanced features to simplify diabetes management for patients. In fact, in the next four years, patients can expect to see more clinical advancements from Medtronic Diabetes than in the last 20 years combined.”

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