The Awards recognise two outstanding researchers in type 1 diabetes with the publication or patent demonstrating the highest innovation, impact and importance in the 2010 calendar year.

Winner – Established Researcher – Dr David O’Neal
Winner – Early Career Researcher – Helen Thomas PhD

JDRF CEO Mike Wilson congratulated to the two researchers. “The term innovation is used often, but it is the holy grail of medical research. The JDRF Macquarie Group Foundation Diabetes Research Innovation Awards awards are significant because they recognise impact as well as innovation.”

“The work of these researchers is not just new, it has demonstrable potential to change the lives of people with type 1 diabetes.”

Dr David O’Neal is Senior Lecturer, Department of Medicine at the University of Melbourne. His work helps to empower people with type 1 diabetes who are using the latest diabetes management technology to make the best decisions with the information produced by continuous glucose monitors.

“We wanted to deliver an educational algorithm that would be a tool to help people to respond in the best way to glucose information – both immediately and retrospectively.”

Helen Thomas PhD is a NHMRC Career Development Fellow at St Vincent’s Institute in Melbourne. Her work was a breakthrough in the understanding of how insulin producing cells – known as beta cells – live and die. The goal is finding ways to protect these cells, primarily for people who have just been diagnosed with type 1 diabetes, as well as those who have received transplants of insulin producing cells.

“Understanding how beta cells are killed in type 1 diabetes is very important if we are to stop the immune system response that leads to their death. Importantly, the molecules identified in this work have unique structure and function making the design of drugs for their inhibition possible.”

The winners of each Award receive a personal award and a cash prize of $5,000 to be used for the advancement of their research career in the field of type 1 diabetes.

The Diabetes Innovation Awards are supported by the Macquarie Group Foundation through its pioneering, long term partnership with the Juvenile Diabetes Research Foundation.

The Australian Civil Aviation Safety Authority (CASA) has changed its regulations to allow people with type 1 diabetes to pilot planes in some circumstances.

So what’s the catch? The license that is initially available is a Class 2 certificate, which allows piloting of private and recreational planes only. Additionally, flying with a safety pilot will be mandatory for 15 incident-free flights.

CASA will require that two ‘recording devices’ (BGMs) are used during flight, with a preference for continuous blood glucose monitoring over traditional methods.  Patients must not have any significant diabetes complications, including retinopathy.

The Medical Journal of Australia (MJA) stated that the relationship between ‘diabetes and aviation has been emotive and controversial, with a perception of conflict between individual rights and the need for aviation safety.’

This means that the regulations are navigating a complex path between the rights of a person with type 1 diabetes and acknowledgement that a blip in diabetes management could lead to harm for the pilot, their passengers and people on the ground.

In the normal course of life, those with type 1 diabetes are the best ones to judge their health and their ability to conduct challenging tasks. This is more possible now than ever before, with help like improved control and management practices, technology like insulin pumps, the latest BGMs and continuous blood glucose monitoring around the corner. Yet regulatory challenges remain for high risk career paths like flying.

The new regulations mean that main challenge facing those who want to pilot planes is control. Applicants will need to prove that they have not had a hypo in the previous year that required the assistance of another person, and that their last 3 HbA1c results over 6 months have been less than 7.5%.

So what’s happening overseas? In the US, private pilots can fly without a safety pilot, as long as they keep their BGM in the range of 5.5 – 16.0 mmol/L. Those levels would be considered ‘running high’ by most people. The MJA noted that this creates an perplexing ethical issue by effectively forcing pilots with type 1 diabetes to risk complications by keeping their BGL relatively high.

For year nine student Brendan, the change in Australian regulations is a promising sign.

Brendan’s dream is to be an Air Force pilot but having had type 1 diabetes for nearly 10 years, this dream is currently out of reach. It is diabetes not airplanes that he thinks of when he first wakes up in the morning and last thing at night.

Brendan is carving out his own air force path. He participates in camps to learn to make model airplanes, as well as other activities like aircraft recognition and survival. He says these activities have been ‘a great way for me to learn more about myself and living well with type 1 diabetes.’

Brendan’s life is full and he says ‘I am having a lot of fun but I believe things must get better as we continue to change the type 1 world we live in.’

‘To make my dream a reality we need to find a different outcome for people living with type 1 diabetes.’

Whilst it has long been known that insulin pump therapy can provide both a physical and psychological benefit to users, results from the recent Sensor-Augmented Pump Therapy for A1C Reduction trial (otherwise known as STAR 3) have shown that using an insulin pump in combination with a continuous glucose monitor can significantly reduce blood sugar fluctuations.

Published in the New England Journal of Medicine, results showed that all patients using the sensor-augmented system demonstrated a reduction in mean A1C levels that was four times greater than patients using insulin injections alone. This lower A1C result was sustained throughout the year of the trial.

An important additional result highlighted by the researchers was that the reduction in average blood glucose levels was not associated with an increased incidence of hypoglycemia.

One of the key steps to the development of an effective ‘artificial pancreas’ is the successful pairing of insulin delivery with blood glucose measurement. This research, in combination with the exciting results being obtained by the JDRF Artificial Pancreas Consortium, show that using a combination system enables users to better manage their glucose levels, even when eating, exercising or sleeping. Ultimately this will result in reduction of long-term complications and hypoglycemia and an increase in quality of life.

The Sensor-Augmented Pump Therapy for A1C Reduction trial was sponsored by Medtronic and involved JDRF-funded researchers across the US.

Published today in the respected journal The Lancet, JDRF-funded researchers developed and successfully tested an automated management system, which was able to predict and prevent blood sugar fluctuations. Dramatic blood sugar drops, or hypoglycemia, have immediate and often devastating consequences and have an enormous impact on both individuals and families living with type 1 diabetes.

The system being tested in this case combined a commercially available insulin pump and continuous glucose monitor with a sophisticated computer algorithm designed to calculate the appropriate amount of insulin required in different circumstances. It was fitted to participants with type 1 diabetes aged between 5-18yrs who were kept overnight at hospital for monitoring.

The results of the trial showed that the children using the system spent twice as much time in a healthy blood sugar range. A further trial showed that that this protective quality did not diminish when participants consumed a large carbohydrate meal before bed and showed an even more positive improvement when participants did strenuous exercise before bed.

According to the Chief Investigator, Dr Roman Horvorka, these results show that commercially-available devices, when coupled with the newly developed algorithm, can improve glucose control in children and significantly reduce the risk of overnight hypos. This is a significant improvement on current management practices and will ideally be moved into wider clinical testing in the home environment.

Dr Dorota Pawlak

Commenting on the research, JDRF Research Manager Dr Dorota Pawlak said “An automated diabetes management system, or artificial pancreas, is the Holy Grail for people who are living with insulin-dependant diabetes.”

“While an artificial pancreas isn’t a cure, it will help to significantly reduce serious diabetic health complications whilst also reducing the burden on individuals and families that live with the constant fear of blood sugar fluctuations.”

“This trial is the first real proof that existing management technology can be expanded to make a dramatic difference to the lives of people living with type 1 diabetes and also their carers.”

This research project is just one element of JDRF’s global Artificial Pancreas Project which is bringing together the best scientific teams across the world to progress development of the artificial pancreas system as fast as possible.  You can find out more at www.jdrf.org/artificialpancreas

This research is only possible thanks to the generosity of JDRF’s supporters.

You can help us speed up the process of bringing the Artificial Pancreas to reality by supporting the Artificial Pancreas Project . Every dollar will help bring research to reality.

The Juvenile Diabetes Research Foundation has today announced an innovative partnership to develop an automated system to help people with type 1 diabetes better control their disease – the first step on the path to what would be among the most revolutionary advancements in treating type 1 diabetes: the development of an artificial pancreas, a fully automated system to dispense insulin to patients based on real-time changes in blood sugar levels.

JDRF has formed a partnership with Animas, a Johnson & Johnson company and a leading manufacturer and distributor of insulin delivery and glucose management systems.

The objectives of the partnership, a major industry initiative within the JDRF Artificial Pancreas Project, are to not only produce the automated system but to conduct extensive clinical trials for safety and efficacy and submit the product to the regulatory authorities for approval and subsidy.

“If successful, the development of this first-generation system would begin the process of automating how people with diabetes manage their blood sugar,” said Mike Wilson Chief Executive Officer of JDRF Australia.

“Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugars within a target range.  But even this early system could bring dramatic changes in the quality of life for the 140,000 Australians living with type 1 diabetes, beginning to free kids and adults from testing, calculating and treating themselves throughout the day.”

Dr. Alan Lewis, CEO and President of JDRF International noted that “JDRF will provide $US8 million in funding over the next three years for this project, with a target of having a first-generation system ready within four years.”

Currently, type 1 diabetes is managed with insulin injected from a needle or an insulin pump and regular fingerprick blood tests. Unfortunately, blood glucose levels can change rapidly in response to hundreds of different triggers making it extremely difficult to accurately predict the amount of insulin required.

This first-generation system will be partially automated, utilising an insulin pump connected wirelessly with a continuous glucose monitor (CGM). The CGM continuously reads glucose levels through a sensor with a hair-thin sensor wire inserted just below the skin, typically on the abdomen.  The sensor would transmit those readings to the insulin pump, which delivers insulin through a small tube or patch on the body.  The pump would house a sophisticated computer program that will address safety concerns during the day and night, by helping prevent hypoglycemia and extreme hyperglycemia.  It would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high.

For example, the system would automatically discontinue insulin delivery to help prevent hypoglycemia, and then automatically resume insulin delivery based on a specific time interval (i.e., 2 hours) and/or glucose concentration.  It will also automatically increase insulin delivery to reduce the amount of time spent in the hyperglycemic range and return to a pre-set basal rate once glucose concentrations have returned to acceptable levels.

In this early version of an automated diabetes management system, the patient would still need to manually instruct the pump to deliver insulin at times, (i.e. around meals).  But this “hypoglycemia-hyperglycemia minimiser” system would represent a significant step forward in diabetes management, and could provide immediate benefits in terms of blood sugar control, by minimising dangerous highs and lows.

The Artificial Pancreas Project was established by JDRF in 2005. You can find out more at www.jdrf.org/artificialpancreas.

You can help speed up the process of bringing the Artificial Pancreas to reality. Support the Artificial Pancreas Project by giving to JDRF. Every dollar will help bring research to reality.

There is extensive research to show that tight blood glucose control is the best way to prevent the onset of type 1 diabetes complications such as kidney failure, retinopathy and heart disease. According to results from the Diabetes Complications and Control Trial, every one point reduction in HbA1C reduces the risk of long-term complications by approximately 40%.

Unfortunately, research has also shown that one of the hurdles to tight blood sugar control is the risk of hypoglycemia – both real and perceived.

Over the past 15 years the use of different insulin analogs as well as improvements in insulin pumps and blood glucose monitoring has had a positive impact on the ability of people to achieve blood sugar control targets. The rates of severe hypoglycemia, however, remain high and occurrence of such events is often followed by a decline of glycemic control due to fears of further hypoglycemic episodes.

In two multi-centre clinical trials – the first concentrating on people with bad glycemic control and the second on people who intensively manage their blood sugars – JDRF researchers have now demonstrated that an excellent solution to this problem is the use of a continuous glucose monitor, or CGM.

According to these trials, people using CGM spent two hours more time per day in the target blood sugar range of 3.9 to 10.0 mmol/l compared with people using fingerprick testing alone. They also found that CGM subjects had a significant overall improvement in HbA1C over time without an increased number of hypoglycemic attacks.

CGM devices are worn in a similar fashion to an insulin pump and provide both a real-time snapshot of glucose levels as well as trend information on whether glucose is moving up or down. They can also provide a warning when glucose is becoming too high or too low.

The continuous glucose monitor is a key component of the JDRF international Artificial Pancreas Program and these results take researchers one step closer to making the artificial pancreas a reality.

Diabetes Care published online 25th May 2009

According to the JDRF study, using CGM devices enables people who have achieved excellent control (with HbA1c levels below 7 percent) to continue to tightly manage their diabetes while cutting down on the frequency of low blood sugars, called hypoglycemia. Research has shown that good blood sugar control is a key factor in reducing the risk of the devastating long-term complications of type 1 diabetes, such as blindness and kidney disease — but that the fear of low blood sugar emergencies often prevents many people from achieving tight control, and remains a constant concern for those who manage their type 1 diabetes well. The landmark Diabetes Control and Complications Trial (DCCT) showed that with intensive insulin therapy, excellent blood glucose control was obtained, but at the expense of a considerable increase in hypoglycemia. Today, the JDRF study has shown that, with CGM, hypoglycemia can be reduced while maintaining excellent blood sugar control.

The CGM study was a randomized and controlled trial involving 129 adults and children ranging in age from 8 to 69 years old at 10 sites, including the Atlanta Diabetes Associates, the Joslin Diabetes Center, Kaiser Permanente Southern California, Nemours Children’s Clinic – Jacksonville, FL, the Lucile Packard Children’s Hospital at Stanford University, the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver, the University of Iowa, the University of Washington, and Yale University, and coordinated by the Jaeb Center for Health Research in Tampa, Florida. Participants all had good diabetes control when they enrolled in the trial, and were randomly assigned to either a group that used CGM devices or one using standard finger-stick glucose testing for 26 weeks.

“The research suggests that CGM devices helped people who were already doing an excellent job of managing their type 1 diabetes continue to do so, while lowering the risk of pushing their blood sugar so low it causes hypoglycemia, which can be life threatening,” said Dr. Bruce Bode, Atlanta Diabetes Associates and one of the lead authors of the Diabetes Care paper. “These trials are showing that CGM not only helps people get into control, which can have a significant positive impact on lowering the risk of complications, but it enables them to stay in control without increasing the near-term risk of hypoglycemia. That’s terrific news for people with type 1 diabetes and their families.”

(People with type 1 diabetes try to maintain their blood sugar levels between 70 mg/dL and 180 mg/dL. When blood sugar becomes very low, people can become confused, lethargic, and even slip into a coma or die. Very high blood sugars can also be dangerous. And long term, lack of control increases the risk of developing devastating complications, including eye, kidney, nerve, and heart disease. HbA1c is a measure of long term blood sugar control; standards of good control are generally below 7% for adults, and below 7.5% to 8% for children, depending on age. According to the DCCT findings, every one point reduction in HbA1c reduces the risk of long-term complications by approximately 40%.)

According to the study, for the people using CGM devices the time the blood sugar level was below 70 mg/dL decreased by 37 minutes a day. This compared with a decrease in the control group of only 5 minutes a day. In other words, people in the CGM group spent almost two hours more time per day in the target blood sugar range of 71 to 180 mg/dL compared with the control group, and about half an hour less time per day with glucose values in the potentially dangerous hypoglycemia range. The authors demonstrated a number of other significant benefits in this population including:

• more people in the CGM group had an improvement in HbA1c of more than 0.3% (31% versus 5% in the control group)
• fewer had a worsening of HbA1c greater than 0.3% (28% versus 52%)
• more CGM users had a HbA1c level below 7% at 26 weeks (88% versus 63%)
• more people in the CGM group than the control group had a decrease in HbA1c of more than 0.3% without experiencing a severe hypoglycemic event (28% versus 5%).

Encouragingly, similar beneficial results were seen in children, adolescents, and adults spanning the ages of 8 to 69 years.

Dr. Aaron Kowalski, Program Director for Metabolic Control at JDRF, explained that in planning this study, the change in HbA1c was not selected as the primary outcome measure because the researchers did not anticipate being able to lower HbA1c levels in the CGM group, given their already exquisite level of control. He noted that the study group expected that there might even be small and clinically insignificant increases in HbA1c values in the CGM group if the devices were able to help them reduce the frequency of glucose levels below 70 mg/dL. Instead, the CGM group was able to maintain HbA1c levels with less biochemical hypoglycemia, whereas HbA1c levels rose over time in the control group. He noted that all the HbA1c outcomes favored the CGM over the control group.

Major eligibility criteria for the study included people over the age of 8 who had type 1 diabetes for at least one year, who either used an insulin pump or took at least three daily insulin injections, and had HbA1c levels below 7.0%. Subjects in the control group were given blood glucose meters and test strips and asked to perform blood glucose monitoring at least four times daily, and met with study personnel as often as the CGM group.

The study is the second major publication resulting from JDRF’s groundbreaking CGM trials, established to clinically document the benefits of CGM devices in helping people with type 1 diabetes manage their disease more effectively. In results published last fall in The New England Journal of Medicine, the JDRF Continuous Glucose Monitoring Study Group reported that CGM substantially improved blood sugar levels without increasing the frequency of hypoglycemia in adults over 25 years of age in a randomized trial of 322 adults and children with type 1 diabetes and HbA1c levels above 7 percent. (Like virtually every other study of a new drug or device in the treatment of type 1 diabetes, because lowering of HbA1c was the primary outcome of interest, that study excluded individuals already reaching target HbA1c levels lower than 7 percent. As a result, the study group also conducted a separate, concurrent randomized trial to evaluate the efficacy and safety of CGM in adults and children with type 1 diabetes who already had successfully achieved HbA1c levels less than 7 percent with intensive insulin therapy.) More information on the initial results of JDRF’s CGM trials and on the Artificial Pancreas Project is available online at http://www.artificialpancreas.org/.

Dr. Kowalski noted that over the past 15 years, the use of rapid and long-acting insulin analogs, improvements in insulin pumps, and more frequent home blood glucose monitoring have had a positive impact on the ability of people with type 1 diabetes to achieve blood sugar control targets. However, the rates of severe hypoglycemia remain too high and the occurrence of such events is often followed by a decline in glycemic control due to fears of further hypoglycemic episodes. Hypoglycemia remains the major limiting factor for people with type 1 diabetes in trying to achieve and maintain good blood sugar control. These study results are extremely encouraging in showing that hypoglycemia can be reduced without sacrificing glycemic control.

For more information, contact JDRF International:

William J. Ahearn
Ph: +(1 212) 479-7531
E-mail: wahearn@jdrf.org

Joana Casas
Ph: +(1 212) 479-7560
E-mail: mcasas@jdrf.org