By: Barbara Klimas | November 16, 2015
Saturday, November 14 was World Diabetes Day, an annual event designed to bring attention to the devastating impact diabetes has worldwide – and the efforts being made to fight this disease. By 2040, almost 642 million will be living with diabetes, many of them children. And the biopharma industry has been working relentlessly to develop new tools and treatments to improve the lives of these patients.
One of the most innovative solutions to emerge from these efforts recently is continuous glucose monitoring (GCMCGM). Anyone who has diabetes or is close to someone who does, knows that one of the greatest frustrations of the treatment for this disease are the constant fingersticks to monitor blood glucose levels. CGMs have the potential to reduce the number of fingersticks a person with diabetes may need to perform, by using a tiny sensor embedded in the patient’s abdomen to continuously track users’ blood glucose levels and transmit that data back to a receiver. This simple device can have a dramatic positive impact on a diabetes patient’s quality of life.
The most obvious benefit of the CGM is the elimination of painful and time-consuming testing. But more importantly, these monitors provide a real-time stream of data about the patient’s condition, which can be shared with caregivers and physicians. The embedded sensor measures the level of glucose in the tissue every 10 seconds, and sends that data via wireless radio frequency to a cellphone-sized device that is attached to a belt or waistline of the users pants. The system automatically records an average glucose value every five minutes for up to seven days before it needs to be changed.
This automated monitoring is especially valuable for parents of diabetic children who now have a way to monitor their child’s health from a distance rather than relying on the child or a teacher to make the proper choices to keep them safe. The monitors also track glucose levels through the night, sending alerts if a user’s glucose levels get too low, giving parents a greater peace of mind. From a disease management perspective, CGMs provide users with insight into their overall health, helping them identify triggers that cause unsafe shifts in their glucose, and strategies to combat these shifts – like following a high carb meal with an aerobic workout.
Faster, easier clinical trials
CGMs also provide compelling benefits for researchers and sponsors conducting clinical trials for new diabetes treatments. Tracking trial participants’ glucose levels can be a costly and time-consuming step in a clinical trial process. Even if patients are recording the results of their glucose monitoring at home, they may only collect a few recordings per day, and researchers face a higher risk of transcription errors, and poor compliance with testing strategies.
CGM eliminates these risks, and provides far more data points to work with. A typical CGM device will generate 288 pieces of data every day. That gives clinicians a much clearer picture of the patients’ overall health, and requires less effort on the patients’ part, which can reduce the risk of attrition from the trial. And, because there is so much data collected, clinicians can shorten the trial duration, and speed decision-making about whether a drug is worth pursuing.
The implications of these benefits are clear and far reaching for diabetes research. And regulators are getting on board. Three years ago, the European Medicines Agency published guidelines for the use of CGM in diabetes drug trials, citing the benefits of improved safety, and improved quantity and quality of data, particularly in nocturnal studies, to support a claim of superiority. These guidelines clearly indicate that regulators understand the value CGM devices bring to diabetes research, and that they are open to reviewing CGM data as part of a trial review process. Currently, only one CGM device is approved for children aged 2-17, but other device manufacturers are pursuing pediatric approvals, and they are all continuing to improve the features of these devices to make them smaller, easier to use, and longer lasting.
While CGMs won’t cure diabetes, they will improve the quality of life for diabetes sufferers, and provide valuable data to researchers that may speed development of other new drugs. And in the fight to cure diabetes, I think that is a development worth celebrating.