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Diabetes has become a global healthcare crisis. One in eleven adults now suffer from diabetes, and 12 percent of global healthcare expenditures are dedicated to this disease.

It’s an expensive and potentially deadly condition that is spurring a lot of research and innovation across the healthcare industry. As the world recently recognized World Diabetes Day, I think now is a good time to explore the impact that one eHealth technology in particular is having on bringing new and better treatments to market.

What’s monitored is managed

Continuous glucose monitoring (CGM) devices are modernizing the way diabetes patients and their physicians monitor and manage their glucose levels. With a CGM device, a tiny sensor is inserted just under the skin to continuously track blood glucose levels and transmit that data back to a receiver. The sensor measures the level of glucose in the tissue every 10 seconds then automatically records an average value every five minutes, which is sent wirelessly to a small blue-tooth enabled receiver.

The benefits of these devices are considerable. Along with eliminating painful blood tests through finger sticks for patients, these monitors provide physicians and caregivers with a real-time stream of data about the patient’s condition, providing hundreds of measures per day. These more robust data sets tell the larger story of a patient’s health to help physicians determine better treatment methods.

Studies show CGM is a meaningful and feasible outcome measure for clinical trial research. By gathering this data remotely, clinical researchers dramatically increase the quantity of data they collect while reducing the time and effort spent gathering it. These capabilities have the potential to shorten the duration of the trial, speed decision-making about whether a drug is working and provide a greater breadth of data to prove results.

As a result, more biopharma companies are considering these tools for their diabetes drug trials, though many have questions about how this data collection method will play into their trial planning, strategy and regulatory approval process. To address these issues, QuintilesIMS recently hosted a webinar with speakers from Dexcom, Lexicon Pharmaceuticals and International Diabetes Center (IDC) at Park Nicollet to explore the benefits and challenges of using CGM in clinical research.

Adding context to A1C

One of the overarching themes of the webinar presentation was the limitations of Hemoglobin A1C tests for tracking glucose levels in trial participants. A1C testing has long been the standard for measuring glycemic control, and it is an excellent population health measure.

A finger stick provides a snapshot in time but doesn’t provide any context around whether a patient’s glucose is trending up or down, or how long it has been in or out of the desired range. CGM provides that perspective, making it a valuable addition to A1C test data in the research environment. Because CGMs collect data hundreds of times per day, these data sets help researcher identify patterns in their patient population, such as how likely a patient is to be out of range in the middle of the night, just before or after meals, and/or following treatment. This data can help them better demonstrate the impact and duration of their treatment, to make dosing decisions, and ultimately to differentiate their trial results from other products on the market.

Another important aspect of utilizing CGM devices in clinical research is ensuring devices are properly calibrated and functioning to agreed upon standards. These standards can include ‘mean absolute relative difference’ (MARD) measures, which compare CGM results to lab results that validate the accuracy of a monitor’s readings.

When CGM data is collected and analyzed consistently in clinical research, it can help researchers better understand the effects of their products, and hopefully lead to CGM-based quality measures of glycemic control in clinical practice.

Biopharma companies interested in pursuing this technology for their research should be sure they choose the best devices to meet their needs, and partners who can help them navigate the complexity of integrating CGM into their research process to ensure they capture data in a format and timeline that is likely to deliver the best results.

You can watch the full webinar presentation here.

 

About The Author

Head of Cardiac Safety Services and Connected Devices and Senior Director, Technology & Automation Solutions