January 26, 2012
The JDRF Canadian Clinical Trial Network (JDRF CCTN) is pleased to announce the launch of the London site of the first multi-centre paediatric study in Canada using insulin pump therapy and continuous glucose monitoring (CGM).
The London site will be led by JDRF CCTN and Lawson Health Research Institute (Lawson) researcher Dr. Cheril Clarson at Children’s Hospital, London Health Sciences Centre (LHSC); the study’s principal investigator is Dr. Margaret Lawson at the Children’s Hospital of Eastern Ontario (CHEO) in Ottawa.
Overall, the study – Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes Trial (CGM TIME Trial) – will involve 128 children and teenagers ages five to 18 years old with type 1 diabetes (T1D). The goal of the study is to find better ways for youths to manage the disease, and in particular, determine the best times to introduce continuous glucose monitoring to this age group.
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. The devices also provide warnings when the glucose is becoming too high or too low.
JDRF’s landmark CGM trials have shown that CGMs can significantly improve diabetes control and decrease the frequency of high and low blood sugars when used regularly.
However, a significant number of children in the studies, and particularly teens and young adults, did not use the CGM devices consistently.
“While insulin pump therapy is popular among children, teens, and their parents, the majority of paediatric pump users do not achieve adequate diabetes control, which means they are still at risk of developing diabetes-related complications in later years,” said Dr. Lawson, a pediatric endocrinologist at CHEO.
“What’s more, recent studies have shown that even testing blood glucose levels 10 times per day isn’t enough; in the periods between testing, many children still experience highs and lows which affect their diabetes control and their sense of well-being.”
“The CGM TIME trial is important because, while we know that CGMs can significantly help children and teens manage their diabetes more effectively when they are used with insulin pumps, it is necessary to determine at what point in their lives they will more easily adopt the diabetes technologies,” said Dr. Clarson, pediatric endocrinologist, Children’s Hospital, LHSC.
“More than three million Canadians live with some form of diabetes. This number is increasing by three to five per cent every year, and the greatest rise is in children five to nine years of age,” said Andrew McKee, president and CEO of JDRF Canada. “This study will explore how children with type 1 diabetes, their parents, and their health care team can optimally manage their disease so that kids can have the best quality of life while reducing the risk of complications.”
The addition of CGM to pump therapy is central to the development of an artificial pancreas system—an automated closed-loop system which would disperse insulin based on real-time changes in blood sugar levels. The artificial pancreas would enable people living with T1D to maintain blood sugar levels within the normal range with minimal effort, resulting in better quality of life and lower risks of complications (www.artificialpancreasproject.com).
“Through our partnership with JDRF, the Government of Canada is supporting innovative diabetes research that will improve the lives of patients in Canada and around the world," said Ed Holder, Member of Parliament for London West, on behalf of the Honourable Gary Goodyear, Minister of State for the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). “These clinical trials are also putting southern Ontario's scientists at the forefront of world-class research and commercialization opportunities.”
The study is being led by CHEO with participation from four other Ontario paediatric diabetes centres: the Children's Hospital at London Health Sciences Centre, The Hospital for Sick Children (SickKids), Markham Stouffville Hospital, and McMaster Children’s Hospital.
Noah Tooke is the Juvenile Diabetes Research Foundation’s Youth Ambassador.