The study out of the Department of Endocrinology and Diabetes at the Princess Margaret Hospital in Perth, found that rates of severe hypoglycaemia in children with Type 1 diabetes declined two thirds between 2000 and 2009.

The study also showed that glycaemic control stayed the same in that time, with the link between glycaemia and risk of hypos growing weaker. There was also no longer an increased risk of severe hypoglycaemia in children under six years old.

The study authors said that the reduction “may have resulted from changes in clinical practice”, including recent developments in new insulin regimes and improved monitoring and management.

JDRF CEO Mike Wilson says “This study demonstrates real results of JDRF’s constant promotion of improved monitoring regimes, and reminds us how important good management is”.

Diabetes Care 2011; doi: 10.2337/dc11-0748

The HypoMon® is described as the world’s first non-invasive system to detect and alert users of sleep-time hypoglycaemia.

JDRF invested in a research project at the University of Technology Sydney in 2004.  The outcome of this research has lead to the HypoMon.

Previously HypoMon has been used in hospitals and now the makers of this technology would like to gather more information about the practicalities of using it at home.

If you are or care for a young person aged between 10 and 25 and you live in the Sydney metropolitan area, you’re invited to apply to use the HypoMon at home for up to 7 nights (1 week).

What’s involved?

• Use the HypoMon system for up to 7 nights, according to the guidelines
• Follow your normal diabetes management routine
• If a hypoglycaemia alarm occurs, self-check your blood glucose level
• Complete supplied logbook of your Blood Glucose Levels every day
• Complete a questionnaire on the last day
• Return the HypoMon at a pre-arranged time and location to the makers of the system

If you are under 18, please talk to your parents. Both you and your parent will need to sign a consent form and your parent will need to be there whenever you meet with staff from the makers of HypoMon.

What will you receive?

• An early opportunity to trial this technology for 1 week
• Two movie tickets at your choice of cinema

Who is trialling the HypoMon?

This opportunity is offered by AIMEDICS, an Australian Innovative Medical Device Company.

What is required from you?

Participate in a 30 minute training session and wear the HypoMon for 7 nights. Supply information about your use of the system.

How will your information be used?

The information collected will help the AIMEDICS product development team improve their product. Some of the information may also be used in their marketing material, however AIMEDICS will not reference names or personal details.

How do you sign up?

Contact Sean Gray via email sean.gray@aimedics.com or call 02 9209 4514.  The selection will be treated by a first in first served basis.

More information
www.aimedics.com
www.hypomon.com

AIMEDICS PTY LTD
ABN 72098304940
Suite 113, National Innovation Centre, Australian Technology Park,
4 Cornwallis Street, Eveleigh, NSW 2015, Australia
Phone: +61 2 9209 4514 | Fax: +61 2 9209 4510

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.

Margaret Harrigan, a teacher from Adelaide, is producing her own insulin for the first time since being diagnosed with type 1 diabetes 36 years ago after receiving an islet transplant in January.

Margaret had spent years living with hypoglycemia unawareness – severe and uncontrollable blood glucose fluctuations that made day-to-day living almost impossible. Four weeks after the transplant, Margaret has almost halved her insulin requirement and is free of dangerous low blood sugar attacks.

This is an exciting milestone for the Australian Islet Transplantation Program with each of the three centres in NSW, VIC and SA now having the expertise and facilities to isolate islets from donors and transplant into recipients.

Whilst the procedure was undertaken in SA, it was a truly national effort with Victorian researchers isolating the islets from the donor pancreas and the NSW team providing expert assistance.

Fourteen Australians have benefited from the Islet Transplantation Program to date with three patients now completely free of insulin injections. Find out more about this program at http://itp.jdrf.org.au.

Cooper is a bright, active, “beautiful” seven year old boy who has had type 1 diabetes since he was three. Back then, while visiting a sick brother in hospital, Cooper picked up a virus. Leah says he never really recovered.

After a high temperature, Cooper started wetting the bed and consuming litres of water every night. He was quickly diagnosed with type 1 diabetes and spent a week in hospital on the general ward, while he recovered and his parents learnt about their new life of needles, fingerpricks and hypos.

The hypos are a worryingly frequent event in little Cooper’s life. Leah says sadly that his control is not very good. “Cooper is very sensitive to insulin. He’ll run really high and the doctor will increase his dose by just one unit to bring it down, but then we run into a spiral of hypos. There is no happy medium.”

As a result of the challenges with his insulin sensitivity, Cooper is currently having two or three hypos every day. Leah counts herself lucky that he has only ever had two overnight hypos, but luck has had little to do with it. She is vigilant at night with her son.

“I check him every three hours through the night because I’m so worried about hypos. I managed to combine it with feeding the baby so I was able to squeeze in a little bit of sleep!”

Cooper’s life with type 1 diabetes is about to change dramatically. The Australian Government has announced a big increase in the subsidy available for insulin pumps, which will make the technology much more affordable for families like Cooper’s.

The Type 1 Diabetes Insulin Pump Program was launched in 2008 and provides a means-tested subsidy towards the purchase of an insulin pump for children under 18. In Australia insulin pumps can cost up to $8,000, making it a medically desirable but unaffordable option for many without private health insurance.

Children under 18 with type 1 diabetes will now be eligible, on the recommendation of a health professional, for a significantly increased subsidy of up to 80% of the cost of an insulin pump, up to a maximum of $6,400. The subsidy will be means-tested and based on a sliding scale reflecting family income.

Research shows that insulin pumps can help in the management of type 1 diabetes by minimising the dangerous fluctuations in blood glucose levels that lead to complications.

Insulin pumps also alleviate the intrusive daily regime of management and injections.

Cooper’s need for supervision of his diabetes is ’round the clock’, so it is clear that an insulin pump is going to change the family’s life.

Leah has always made excuses for him to avoid birthday parties, and Cooper has never stayed overnight with grandparents or friends. Leah says “It is understandable that most other people don’t feel comfortable giving him needles and it’s a big responsibility to hand over.”

Cooper will still have type 1 diabetes after he gets an insulin pump and he may still experience hypos. But his diabetes management will get a lot easier. Insulin adjustments on pumps can be made in 0.05 unit increments.

Cooper is excited but nervous. Currently he has all his needles in his bottom, because he is very small and with no fat on his tummy, it quickly gets lumpy when he has injections there. The doctor has reassured him that he can have his pump site on his bottom too, minimising the pain of the site change.

For the next few weeks, he will watch Leah’s friend who has type 1 diabetes do a bolus dose on her insulin pump for her coffee and cake, and imagine all the things he will be able to do for the first time when his insulin pump arrives.

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.

After extensive discussion in Australia and overseas, Australian diabetes health professionals have released a new position statement on blood sugar targets for people with type 1 diabetes. Following the results of the Diabetes Control and Complications trial, the ideal target of a HbA1c of 7% was set across the board.

Recent research has suggested that one size may not fit all and to address this, the Australian Diabetes Society now officially recommends that people with severe hypoglycemia or hypoglycemia unawareness should set their HbA1c targets at 8% or less.

Medical Journal of Australia

Diabetic ketoacidosis still common

Research from Germany has indicated that one in five children diagnosed with type 1 diabetes will suffer severe diabetic ketoacidosis at disease onset – a rate that has remained constant over the last 13 years even though major have been made in diabetes care during that time.

It has been suggested that this may result from a lack of recognition of symptoms by general clinicians. In many cases this leads to a dangerous delay in diagnosis, resulting in an increased risk of complications like ketoacidosis and removing the opportunity to protect remaining insulin-producing cells.

The International Diabetes Federation has called for increased public awareness of the early symptoms of type 1 diabetes leading up to World Diabetes Day on November 14, 2009.

Diabetes Care

Australian researchers discover molecule involved with beta cell death

A JDRF-funded research team from the Walter and Eliza Hall Institute has conclusively identified the role of a molecule suspected of triggering the death of beta cells. Researchers showed that the molecule – called Fas ligand – is present in two different forms.

One protects against autoimmunity and the other, in large concentrations, can increase the risk of autoimmune attack. Researchers are now looking to use this knowledge to create a therapy to slow down the autoimmune attack or prevent type 1 diabetes onset altogether.

Nature

MRI may help physicians diagnose type 1 diabetes

A non-invasive MRI scan may help clinicians to diagnose and identify suitable treatment plans for, type 1 diabetes.

According to researchers at Harvard Medical School, MRI scans can evaluate beta cell mass as well as detect any inflammation of the pancreas. This technique will therefore identify if a person is experiencing the autoimmune process associated with type 1 diabetes, as well as calculating how many functioning beta cells might be left.

Having this information would allow clinicians to prescribe a treatment plan suitable for the disease stage.

The first study showed that regular use of CGMs is the main factor in achieving better diabetes control, rather than the age of people using the monitors, or other demographic, clinical, or psychosocial factors.  The second study showed that people using CGMs were able to achieve good diabetes control while at the same time actually lowering the incidence of hypoglycemia.

This is significant because good diabetes control is critical for reducing the risk of serious health complications associated with diabetes, like stroke, blindness, heart disease and kidney failure. However, this tight control can be difficult to achieve and is associated with increased occurrence of hypoglycemia, which is dangerously low blood glucose levels that can lead to coma or death. These results suggest that regular use of CGMs can overcome this risk.

“Based on these results and previous JDRF CGM trials published over the past 12 months, we know that these devices can help people get in control of their diabetes, help people already managing their disease maintain good control, and help people stay in control over an extended period of time, while lowering their risk for hypoglycemia,” said Dr. William V. Tamborlane, of Yale University, a co-chair of the JDRF funded study.

JDRF Australia CEO Mike Wilson said these results were important for Australia. “Consistent use of CGMs is now proven to have significant benefits for all people with type 1 diabetes.”

“CGMs are expensive for Australians but this research suggests that widespread use would deliver substantial savings for our health system in the long term. The type 1 diabetes community needs maximum access to technology that will improve both their health and their quality of life.”

These trials are part of JDRF International’s Artificial Pancreas Project. More information is available online at http://www.artificialpancreas.org. The findings of the two JDRF studies from the major multi-center trial have been published online by Diabetes Care at http://care.diabetesjournals.org/papbyrecent.shtml.

About CGM Devices

CGM devices provide both a real-time snapshot of the glucose levels of a person with diabetes, as well as trend information on whether glucose is moving upwards or downwards, and how fast.  Devices also provide warnings when the glucose is becoming too high or too low.

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