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ASA Ruling on Abbott Laboratories Ltd – Advertising Standards Authority

1. The innovation that won them victory is an appliance designed to help diabetic patients, which measures blood sugar levels with no need for pricking the skin. These lancets are usually spring loaded and/or adjustable to reduce pain. Alternate sites such as your forearm, have less nerve endings, which means virtually no pain when pricked. The device uses LED lights and a small sophisticated camera to measure the color of your blood. Spectroscopy Lab graduate students Ishan Barman and Chae-Ryon Kong are developing a small Raman spectroscopy machine, about the size of a laptop computer, that could be used in a doctor’s office or a patient’s home. The reader is able to scan even when the sensor is obstructed by clothing, which means testing can be done discreetly and conveniently.

The reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time. “We started the work on tattoo-based devices in early 2012, considering the tattoos’ unique aesthetic as well as technological properties for developing wearable sensors,” Amay Bandodkar, a researcher in Wang’s lab, told Tech Page One. When a woman undergoes both the blood and ultrasound screening, her doctor usually will calculate the results together. “Currently, we are piloting a bench top version in our clinical investigations but aim to develop two types of devices for the market. They also pointed out that a link appeared alongside the text to a video which showed a woman, Helen, carrying out day-to-day activities and which they believed made it clear that she was not suffering from any non-routine conditions. As the light wave passes through the fingertip, some of it is absorbed and the light signal is changed. One will be a finger-touch device similar to a computer mouse.

They supplied evidence that they believed showed that the FreeStyle Libre Flash Glucose Monitoring System accurately recorded interstitial glucose levels with an overall 11.4% Mean Absolute Relative Difference compared to fingerstick capillary glucose testing; that there was good correspondence between the glucose levels measured in subcutaneous interstitial fluid and glucose levels measured from capillary blood; that glucose measurement by subcutaneous interstitial fluid was a suitable replacement for blood glucose measurement and that their system was a satisfactory replacement for routine blood glucose testing; and that there was good understanding within the diabetes community of when non-routine testing was required. The ASA noted that the headline claim “YOU CAN DO IT WITHOUT LANCETS” was followed by further text which stated “Why prick when you can scan?” and “The days of routine glucose testing with lancets, test strips and blood are over”. We noted that the third phrase made reference to “routine glucose testing” and was linked to qualifying text which stated “A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels, or if hypoglycaemia or impending hypoglycaemia is reported but the symptoms do not match the system readings”. Glucose levels are visible on the pump screen as numbers and a graph. We considered the claim, in the context of the ad, suggested that the device was sufficient for routine testing other than in the situations where the qualification stated that finger prick testing was required. We took advice from an expert. We noted that Abbott had supplied several articles and studies which they considered demonstrated the accuracy of sensor-based monitoring and the awareness among people with diabetes of the difference between “routine” and “non-routine” situations and testing.

We noted that the number of subjects taking part in the studies was not large and that, while they drew conclusions that were cautiously positive in relation to the accuracy of sensor-based monitoring, they also expressed concerns about factors that would have an adverse effect on accuracy and reliability. Nevertheless, we considered the studies were well conducted and that, although the number of subjects was not large, the number of readings tested was considerable, with the readings showing a strong degree of correlation with plasma glucose tests conducted by taking blood from a vein (considered to give the most reliable reading but not always a practical method for people with diabetes to use for regular monitoring away from a medical environment) and with finger prick testing. We considered the results suggested that the device was sufficiently accurate in day-to-day testing to take the place of routine blood glucose testing (such as on waking and just before meals) using a finger prick test in most circumstances, except where glucose levels were changing rapidly or when symptoms did not match the system readings. We considered people with diabetes used to managing their condition would be familiar with the circumstances referred to by the qualification, as well as other circumstances where a finger prick test using a blood glucose meter was required, such as prior to driving and regularly throughout a long journey while driving. We therefore concluded that the claim was unlikely to mislead. We investigated the ad under CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products), but did not find it in breach.

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