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Diabetes Blood Glucose Monitoring

individuals with diabetes and their healthcare teams to maximise euglycaemia. Real-time information can help individuals understand the relationship between lifestyle and dietary choices and their glucose dynamics while retrospective data can help healthcare professionals identify glycaemic patterns and optimise treatment programmes. In addition, real-time monitoring devices can provide customisable alarms that warn of impending hyper- and hypoglycaemia, which will likely ease fear of hypoglycaemia to support implementation of treatment programmes focused on intensive blood glucose control.

Non-invasive and Non-intrusive to Increase Frequency of Use

A CGM device with a non-invasive, pain-free sensor that does not require frequent replacement would go a long way towards supporting such frequent use. To be truly non-invasive, the monitor must be a non-in vitro diagnostic device – one that does not require a blood, fluid or tissue sample. Obtaining a sample requires disturbing or penetrating the skin barrier, which is unlikely to be painless or non-intrusive. In addition, because truly non-invasive monitoring would not cause injury or trigger a foreign-body response, it would not be subject to the negative impact those events can have on accuracy.62,63

To deliver benefit, CGM devices must be used, preferably about 70 % of the time.8,49,50

Furthermore, many individuals with diabetes have the perception that CGM devices interfere with daily activities.60

A glucose

monitor that could be worn discreetly and be removed when desired without requiring the inconvenience and cost of sensor replacement and recalibration would likely change this perception for the better. In fact, such a device could encourage individuals with diabetes to pursue a wider range of interests since they could keep a close eye on glucose levels throughout most activities.

An ideal glucose monitor, being accurate, continuous, non-invasive and non-intrusive, and having a long-life sensor, would undoubtedly increase the frequency of CGM use and empower individuals to assume more control over their diabetes, improving health and quality of life. Not surprisingly, a number of efforts are underway to develop such a monitor – some closer than others, and some more likely to succeed than others. A larger number of efforts have already come and gone, including the Dream Beam (Futrex Medical Instrumentation Inc.), Diasensor® (BICO Inc.), GlucoWatch® (Cygnus Inc.) and Pendra® (Pendragon Medical Ltd.) CGM devices. Table 1 provides an overview of RT-CGM devices for home use that are actively being developed or already on the market.

Looking Ahead

Since the discovery of insulin in 1921, medical technology has continued to improve the management of diabetes as well as make life easier for individuals living with the disease. Before 1975, urine monitoring and a fixed dose of insulin once or twice a day was the general standard of care. Since then, medical advances, such as disposable syringes, laboratory glucose tests, continuous insulin pumps, home-use blood glucose meters and, most recently, continuous glucose monitors, have advanced steadily, with each next-generation product delivering added benefit.

It seems likely that the next step in the advancement of medical technologies for diabetes management will be a non-invasive CGM device that meets some, possibly all, of the characteristics identified by healthcare professionals and individuals with diabetes. Such a


Table 1: Overview of Continuous Glucose Monitoring Devices for Home Use on the Market and in Active Development (i.e. those Devices for which a Press Release has been Issued or a Paper has been Published within the Last Two Years)

Manufacturer OrSense Ltd.A

Abbott Diabetes CareB DexcomC MedtronicD

A. Menarini DiagnosticsE C8 MediSensorsF Echo TherapeuticsG CYBIOCAREH

Integrity ApplicationsI

Sensors for Medicine & ScienceJ

Device FreeStyle Navigator CGM

SEVEN Plus CGM CE Mark, FDA Approval Electrochemical Guardian RT CGM CE Mark, FDA Approval Electrochemical GlucoMen Day CGM Investigational HG1-c nCGM

Microdialysis Investigational

Symphony tCGM Investigational PGS

GlucoTrack nCGM Investigational SMSI Glucose Sensor Investigational Investigational

Abdomen Abdomen Abdomen

Raman spectroscopy Abdomen Electrochemical Near infrared and physiological

Abdomen Arm

Ultrasonic, electro- magnetic, thermal Fluorescence chemistry

Ear Forearm

No No No

Yes No

Yes Yes Yes

No No No

Yes No

Yes Yes No

Yes Yes Yes Yes Yes Yes

Yes Yes

No No No

Yes No No

No No

No No No

Yes No No

No§ No Status NBM 200G CGM CE Mark (Investigational) CE Mark, FDA Approval‡

Technology Occlusion

spectroscopy Electrochemical Abdomen No No Yes No No 12.8 % +

13.6 % (MARD)68 17 % (MAPD)67

19.7 + 18.4 (MAPD)67 10 % (MARE)73 Not available Not available Not available

25.6 %74 Not available

A.; B.; C.; D.; E.; F.; G.; H.;; J. *Sensor life greater or equal to six months. †CGM devices that require calibration via a SMGB device require consumables to support that calibration. ‡Discontinued in the US. §Sensor must be calibrated monthly. MAE = median absolute error; MAPD = mean absolute per cent difference; MARD = mean absolute relative difference; MARE = mean absolute relative error.

Sensor Location Long-Life* Non-Invasive Non-Intrusive Consumable-Free† Finger

Yes Yes No Yes

Calibration-Free Accuracy No

13.2 % (MAE)72

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