Introduction CGM
Continuous Glucose Monitoring (CGM) has emerged as an indispensable tool in both the management and investigation of metabolic diseases. For scientists engaged in clinical research, especially in diabetes, obesity, and NAFLD/MASH, CGM offers unique advantages over traditional glucose monitoring namely, temporal resolution, real-world applicability, and rich data streams suitable for advanced analytics.
This post outlines CGM’s research applications, methodological benefits, and its integration into early-phase clinical trials.
CGM: From Point Measurement to Dynamic Glycaemic Profiling
Unlike static measures that provide single time-point glucose readings, CGM captures glucose values every few minutes, typically over 24-hour periods and across multiple days. This continuous data stream reveals complex glucose dynamics, including postprandial excursions, and subtle patterns in glycaemic variability.
Modern CGM systems offer factory-calibrated sensors, long wear times, and high accuracy, with mean absolute relative differences (MARD, the most widely accepted accuracy measure) below 9%. These features make CGM not only user-friendly for trial participants but also highly reliable for collecting high-frequency glucose data in both ambulatory and controlled research settings.
Advantages of CGM in Clinical Trials
One of the most significant contributions of CGM to clinical research is its ability to quantify glycaemic variability, time-in-range (TIR), and time-above or below target thresholds. These parameters are increasingly recognized as relevant clinical endpoints. For example, TIR correlates with HbA1c and microvascular complication risk, and has been proposed as a complementary endpoint in early-phase trials evaluating pharmacodynamic effects.
CGM enables researchers to observe how glucose-modulating therapies behave outside the artificial constraints of in house research conditions, capturing variability over days and across physiological states such as fasting, exercise, or sleep.
CGM also contributes to participant safety, especially in trials involving new insulin analogues or metabolic agents with unknown hypoglycemic potential. Real-time glucose data allows for early detection of glycaemic excursions, while alerts and remote monitoring tools help reduce the risk of severe hypoglycemia in both inpatient and outpatient settings.
Beyond glucose-lowering drugs, CGM plays a growing role in studies investigating lifestyle interventions, circadian alignment, nutritional strategies, and liver-targeted therapies. Its ability to detect nuanced shifts in glucose regulation makes it particularly valuable in obesity and fatty liver disease research, where glycaemic dysregulation may precede overt diabetes.
Profil’s Approach to CGM in Clinical Research
At Profil, CGM is integrated into our early-phase trials across a wide range of indications—from type 1 and type 2 diabetes to obesity and metabolic liver disease. Our studies often pair CGM with fully automated glucose clamps (e.g., ClampArt®), mixed-meal tolerance tests (MMTT), imaging techniques such as MRI and MRS, and extensive biomarker profiling. This multimodal strategy enables us to generate high-resolution, clinically relevant metabolic phenotypes that enhance both the interpretation of drug action and the quality of decision-making in early development. Depending on the circumstances open CGM (data immediately visible to participant) or blinded CGM (data not visible to participant) may be preferable.
Whether assessing the effects of insulin action, or evaluating glycaemic patterns following liver-directed therapies, CGM provides the continuous lens needed to fully characterize pharmacodynamic responses in a physiological context.
Looking Ahead
As metabolic research moves toward greater personalization and data integration, CGM is poised to play an even larger role. Improvements in sensor longevity, non-invasiveness, and AI-driven data interpretation are on the horizon, and will further expand the utility of CGM across populations and research settings.
For scientists developing the next generation of therapies for metabolic disease, CGM is not just a monitoring tool—it is a powerful research instrument. Its capacity to capture the complexity of glucose behavior in real time offers a unique opportunity to enhance the quality, precision, and translational value of clinical research.
Interested in integrating CGM into your early-phase trial design? Contact the Profil team to learn more about our advanced metabolic phenotyping platform.