Digital biomarkers and precision monitoring: what’s new in diabetes testing?

The need for precision medicine to inform diabetes management decisions is widely understood, but how can we achieve it? Precision monitoring could be the enabler.

Historically, biomarkers have been complex measurement process unsuited to home testing and involving expensive data points. Diabetes biomarkers may include blood glucose drawn at a clinical lab and mean glycaemia expressed as an HbA1c blood test. But times are changing and in recent years, digital biomarkers have been on the rise.

Digital biomarkers are collected and measured by means of digital devices such as portables, insertables, wearables, implantables and ingestables. Measurement of these biomarkers is simple and tends to require minimal effort or invasion often applied by a sensor in a non-medical setting. The metrics are quantitative and suitable for continuous monitoring. Data collection is inexpensive and could measure anything using a wearable sensor.

As part of the American Diabetes Association (ADA) and EASD ‘Precision Diabetes Medicine Conference 2021’, David Klonoff delivered a talk on precision monitoring and technology in diabetes care, in which he discussed digital biomarkers and the promising opportunities presented by precision monitoring in diabetes.

In diabetes testing, a continuous glucose monitor data point is a digital biomarker that is part of a data stream with reference testing using a different matrix, blood, to the measurement, interstitial fluid. A digital sensor is activated when a patient produces physical signals, for example metabolic, biophysical or auditory. Within the sensor the signal is converted to the transducer. This is then converted to an output and typically emerges as an electrical signal carried by a wire, or more frequently now via wireless signals, either to a visual display and/or a computer network. When the output has been stored and analysed, a digital representation of the patient is formed. This, Klonoff explained, is the key to monitoring with a digital sensor.

Within the multidimensional framework of diabetes precision medicine, it could be argued that precision monitoring is the most important process because of its effect on other aspects of precision medicine. Precision monitoring overlaps all other dimensions of diabetes precision medicine and equips clinicians with information to provide treatment recommendations. Monitoring informs prognosis by warranting a doctor to consider the amount of non-modifiable risk factors for diabetes and/or its complications present in the patient; if the observed factors are modifiable, the doctor is left being able to make decisions for prevention.

Novel enabling technologies for diabetes precision monitoring include diabetes digital health. Digital health is a combination of sensors, a smart phone, and software. Sensory information can be processed on a smart phone using software, arming clinicians with treatment recommendations, decision support and control of devices such as automated insulin delivery systems. The first person to use a wearable as a type of enabling technology was astronaut, inventor and engineer Mae Jemison, who 15 years ago developed a continuous autonomic nervous system monitor, explained Klonoff.

The most popular enabling technology is continuous glucose monitoring. Newer forms of enabling technologies include artificial intelligence, and specifically machine learning, attractive to healthcare professions who wish to understand the many kinds of data streams in precision medicine. Edge computing is a tool useful for situations in which you need an immediate decision and minutes cannot be spared. One example of an edge computing device is a closed-loop system automated insulin delivery system. 

With so much in the pipeline, the developing technology for precision monitoring promises to supports and uphold other precision diabetes medicine efforts. Klonoff concluded the session by emphasising that there is a need for precision medicine to be applied to diabetes to better inform management decisions, and that monitoring supplements diagnosis, treatment, prognosis and prevention.

‘Precision Medicine in Diabetes: A Consensus Report From the ADA and the EASD’ was published in Diabetes Care in July 2020.

For more on precision monitoring, enrol on our courses ‘Technology and type 1 diabetes’ and ‘Time in range’.

For more on precision medicine, enrol on our course ‘Phenotypic variability of type 2 diabetes’.

The opinions expressed in this article are those of the author, Dr Eleanor Kennedy.