Johnson & Johnson company LifeScan is launching a clinical trial to determine whether its OneTouch Verio blood glucose meter (or a not-yet-launched version of it) creates a greater reduction in A1C levels when used in conjunction with its companion app.
According to a post on ClinicalTrials.gov, the company is recruiting 148 patients for a randomized control trial that will compare patients using the OneTouch Verio Flex Blood Glucose Management System alone to patients using it with the LifeScan OneTouch Reveal app. Secondary outcome measures include adherence to regular glucose testing, use of the app over 24 weeks in the app group, and patient satisfaction.
The OneTouch line at LifeScan includes the Verio IQ, Verio Pro, and Verio Pro+, but nothing called the Verio Flex, although Johnson & Johnson was just granted a trademark for that name on April 22.
The trial will also involve some participants receiving text messages from their health provider as part of the study. It's unclear whether this is a feature of OneTouch Reveal that's being evaluated for future launch or part of the control procedure.
LifeScan's smartphone-connected glucometer was shown off at Apple's Worldwide Developer Conference in 2009, but then took a number of years to actually seek and receive FDA clearance before finally launching as the Verio IQ meter in March 2013. Then, less than two weeks after that launch, the company voluntarily recalled the meter because it was shutting down in cases of especially high readings.
In January of this year, LifeScan launched the OneTouch Verio Meter, a new version of the meter designed to make readings easier to understand. In April, it launched the second version of the OneTouch Reveal smartphone app, which moved all user data from local storage into a secure cloud. The update also expanded the diabetes logbook to 12 months; added 14-, 30-, and 90-day overviews; and added the ability to share the logbook as a PDF or exported data table.
The clinical trial was set to begin last month, and is slated to finish in May 2016.
