Background
Summary of Council decision:
Two issues were investigated, of which one was Upheld and one was Not upheld.
Ad description
A website and Youtube ad for Abbot Laboratories, seen in September 2017:
a. The website www.freestylelibre.co.uk included text on the home page which stated “WHY PRICK WHEN YOU CAN SCAN?1 You can now check your glucose levels anytime, anywhere!2 Just scan the FreeStyle Libre sensor to see your current glucose reading, where it's heading and the last eight hours of continuous data”. Text also appeared on the FAQ page which stated “What does 'Flash' mean? ‘Flash’ reflects the fact that users can obtain glucose readings quickly by just scanning the reader over the sensor*...*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 hypoglycemia or impending hypoglycemia is reported or the symptoms do not match the system readings”.
b. The Youtube ad showed different people using the device and included a voice-over which stated, “Just scan the sensor to see your current glucose reading”. During this voice-over the user was shown receiving their glucose reading on the display of the device instantly. Small text at the bottom of the screen stated “Always read the user manual. For advice on treatment of your diabetes please consult your doctor…”.
Issue
The complainant, who understood the latency for an interstitial fluid test result could be 10 to 20 minutes behind that of a blood test result, challenged whether:
1. the claim, in both ads, “Just scan the FreeStyle Libre sensor to see your current glucose reading” misleadingly suggested it would be able to provide an instant reading of a user’s glucose reading; and
2. the ads were misleading because they did not make sufficiently clear finger-prick testing was still required during times of rapidly changing glucose levels.
Response
1. Abbot Laboratories said the FreeStyle Libre system was designed to replace routine blood glucose testing in the self-management of diabetes and did in fact provide an instant reading of a patient’s glucose levels obtained from interstitial fluid. They said the system allowed the user to wirelessly query glucose data from the Sensor by bringing a handheld Reader in close proximity of the Sensor. They said the act of scanning a Sensor provided the user with an instant real-time interstitial glucose measurement which was presented on the Reader display. They said the Sensor could be scanned by the Reader as frequently as desired, and a current glucose value would be displayed in one minute increments.
They said with regards to the latency for interstitial fluid, physiological lag times between blood and interstitial had been quoted as 12–20 minutes by various investigators. Capillary blood, venous blood and interstitial fluid glucose values could also vary between each other, depending on whether glucose was measured just before a meal or after. However, the FreeStyle Libre system lag time could be shorter than that, as the physiological lag could be accounted for. Further, the inbuilt algorithm could make the lag shorter when glucose was reported by a system, correcting for the physiological lag. They provided evidence they believed demonstrated the FreeStyle Libre system had been clinically shown to have an average lag time between the sensor interstitial fluid glucose value and the blood glucose reference of 4.5 ± 4.8 minutes. Therefore they believed the claim “Just scan the FreeStyle Libre sensor to see your current glucose reading” was valid and was not misleading.
2. They said they believed they had made it clear that finger-prick testing was still required as there was information on their website which clearly indicated when a finger prick was required, including a finger-prick instruction; such references were repeated throughout the website and a dedicated web page also detailed the difference between the glucose measured by the FreeStyle Libre sensor and blood glucose values.
They said while blood glucose measurements taken via finger pricking could differ from glucose readings taken from interstitial fluid, they were likely to be similar in most cases. However, as those glucose readings might differ at times, such as after meals, exercise or taking insulin, they said the FreeStyle Libre system did require finger pricking, firstly, in instances of rapidly changing glucose levels. This was because interstitial glucose levels measured by the Sensor and reported as current at those times might not have accurately reflect blood glucose levels. They said when glucose levels were rapidly falling, the Sensor readings might have been higher than blood glucose levels. Conversely, when glucose levels were rapidly rising, the Sensor readings might have been lower than blood glucose levels. They said finger pricking was also required to confirm hypoglycaemia or impending hypoglycaemia as reported by the Sensor and, finally, if symptoms did not match the FreeStyle Libre Flash Glucose Monitoring System reading. They said a user should not ignore symptoms that might have been due to low blood glucose or high blood glucose.
They said these three instances where finger pricks were required were included in the FreeStyle Libre User Manual. They said some differences (for example, before versus after meals) were seen with capillary versus venous blood and were well understood by people with diabetes and healthcare professionals. They said the methods were therefore considered equivalent in general but for the three exceptions specified above. They said this was the reason the YouTube ad referred users to the User Manual.
Assessment
Not upheld
1. The ASA considered that ads (a) and (b) were targeted at consumers living with diabetes and those consumers would understand the claim “Just scan the FreeStyle Libre sensor to see your current glucose reading” to mean that the product would provide an accurate and immediate glucose reading for managing their diabetes. We had previously assessed evidence submitted by the advertiser, which was reviewed by an expert. For the reasons stated in our 2015 ruling, we understood there was no additional relevant evidence to consider and therefore we considered 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 therefore considered that the interstitial glucose measure provided by the device was an accurate measure for managing diabetes. We also considered that Abbot Laboratories had demonstrated the product did provide an instant reading of a user’s interstitial glucose level.
For these reasons, we did not consider the claim “Just scan the FreeStyle Libre sensor to see your current glucose reading” was likely to mislead.
We investigated that point under CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading Advertising), but did not find ads (a) and (b) in breach.
Upheld
2. Notwithstanding the above, we considered that the requirement to carry out a finger-prick test using a blood glucose meter in certain circumstances when using the FreeStyle Libre device was likely to be material information to these consumers and therefore should be clearly presented. We noted that information appeared on the FAQ page of the website and, in order to see the relevant text, a consumer had to first click through the category titled “sensor”, then click through to the second page of questions and then click an enclosure titled “Is the accuracy of the sensor consistent over the 14-day wear period?”. We therefore concluded that this information was not sufficiently clearly presented to consumers and concluded that ad (a) was misleading on that basis.
Further, there was no information about the requirement to carry out a finger prick in ad (b) and, in the absence of that material information, we concluded that ad (b) was misleading.
On that point, ads (a) and (b) breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading Advertising),
3.9
3.9
Marketing communications must state significant limitations and qualifications. Qualifications may clarify but must not contradict the claims that they qualify.
and
3.10
3.10
Qualifications must be presented clearly.
CAP has published a Help Note on Claims that Require Qualification.
(Qualification).
Action
Ads (a) & (b) must not appear again in the form complained of. We told Abbot Laboratories to ensure they made clear a finger prick test using a blood glucose meter was required in certain circumstances when using their product.
