Abbott Meets UK Claim On OTC Glucose Test Time But Misses On Finger Prick
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
The firm substantiated the test quickly produces glucose readings for users, but misled consumers by explaining the finger-prick part of the process on an FAQ page accessible with multiple clicks past the brand's website homepage. FreeStyle Libre features a sensor that attaches to skin on the back of the arm and a wireless device that reads information from the sensors.
Digital advertising for Abbott Laboratories Ltd.’s FreeStyle Libre Flash OTC glucose monitoring system shouldn't hide that finger pricks still are needed sometimes, the UK Advertising Standards Authority says.
The firm substantiated that the test quickly produces glucose readings for users, ASA said, but its advertising misled UK consumers by explaining the finger-prick part of the process on the frequently asked questions page accessible with multiple clicks past the brand's website homepage.
“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,” ASA said in its ruling published Feb. 21.
FreeStyle Libre features a sensor that attaches to skin on the back of the arm and a wireless device that reads information from the sensors. Users scan sensors with a reader to determine current blood glucose levels and a trend on their glucose levels over a period of days.
A consumer challenged the brand website ad claim, contending a message of instant results is not accurate because the latency for an interstitial fluid test could be 10 minutes to 20 minutes behind that of a blood test result and did not make sufficiently clear finger-prick testing was still required during times of rapidly changing glucose levels; and a YouTube ad that ran in September 2017, saying it did not make sufficiently clear finger-prick testing was still required during times of rapidly changing glucose levels.
The brand's FAQ page said "Flash" is part of the product name for a reason, saying it "reflects the fact that users can obtain glucose readings quickly by just scanning the reader over the sensor.” The statement was followed by an asterisk for the footnote: “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."
Abbott responded to ASA's review saying its system was designed to replace routine blood glucose testing in the self-management of diabetes and provides an instant reading of glucose levels obtained from interstitial fluid. It said the system allows users to wirelessly query glucose data from the sensor with the handheld reader.
Scanning a sensor provided users with instant real-time interstitial glucose measurements presented on the reader’s display, Abbott said. The firm provided evidence it said demonstrated the system had been clinically shown to have an average lag time between the sensor interstitial fluid glucose value and blood glucose reference of between 4.5 to 4.8 minutes.
ASA concluded that the ads' target market, consumers with diabetes, would understand the claim “Just scan the FreeStyle Libre sensor to see your current glucose reading” to mean the product would provide an accurate and immediate glucose reading for managing their diabetes. It said Abbott submitted sufficient evidence to demonstrate the product provided an instant reading of a user’s interstitial glucose level.
Three Clicks Away Is Not 'Clearly Presented'
Abbott also maintained it made it clear the finger-prick test still was required in certain situations, such as to confirm hypoglycemia or impending hypoglycemia as reported by the senor, and if a person’s symptoms did not match the FreeStyle Libre reading.
It pointed out the product's manual describes the three instances when finger pricks are necessary and that the YouTube ad referred users to the manual.
The brand home page featured the statement, “Why prick when you can scan?” with a footnote at the bottom that stated, “scanning the sensor to obtain glucose values does not require lancets.” The YouTube ad showed different people using the device with a voice-over stating, “Just scan the sensor to see your current glucose reading,” before a person receiving a glucose reading on the display 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.”
However, ASA determined the requirement to carry out a finger-prick test in certain cases when using the device was “likely to be material information to these consumers” and should therefore 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 tilted 'sensor,' then click through to the second page of questions and then click an enclosure tilted ‘Is the accuracy of the senor consistent over the 14-day wear period?’ We therefore concluded that this information was not sufficiently clearly presented to consumers and concluded” the website ad was misleading. The YouTube ad did not contain any information about the requirement for carrying out a finger prick test and is also misleading, ASA said.
ASA conducted a similar review of FreeStyle Libre in 2015 on a complaint that a claim the product could measure glucose levels “without lancets” was misleading and the firm could not substantiate that the senor attached to skin could measure glucose as reliably as traditional methods. However, ASA found Abbott substantiated those messages. (Also see "Enforcement Roundup: Spiked Imports, UK Ad Claims" - Pink Sheet, 23 Nov, 2015.)
From the editors of the Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the website.