Patients Start Clinical Trial of the FreeStyle Libre Pro
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Clinical Trial Identifier: NCT02336945
Trial name: Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional.
Diabetes type: Type 2 diabetes.
What it’s testing: The trial is testing a “professional” version of the FreeStyle Libre, which is a product (already launched in Europe) intended as a replacement for blood glucose meters that does not require fingersticks. This professional version – the “Libre Pro” – differs from the consumer version in two main ways:
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Glucose data from the Libre Pro is blinded from volunteers, whereas the consumer version comes with a touchscreen reader to download the data; and
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The Pro sensor can track glucose data over a two-week period whereas the Libre sensor only tracks glucose data history over an eight-hour period (this is why the consumer version recommends scanning with the touchscreen reader every eight hours).
Volunteers in the study will wear two Libre Pro sensors (one on each upper arm) for two weeks, during which time they will go about their normal daily activities and follow their typical diabetes management plan.
What’s the trial trying to show? The study’s main objective is simply to ensure that the Libre Pro is able to gather accurate glucose data over a full two-week period. The trial will measure the participants’ glucose variability, as measured by the Libre Pro sensor, but again the data is not intended to alter volunteers’ daily activities or treatment plan.
Why this is new/important: The Libre Pro would be used by health care providers, who would give a patient the sensor to wear for two weeks and would download the data at the end of that time period. As in the trial, patients in the real-world setting would not see the glucose data until after the two weeks is over. Why? Two main reasons:
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It ensures that patients don’t change their typical behavior based on the Libre Pro data, allowing health care providers to get a more realistic sense of a patient’s glucose levels over time; and
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Doctors may not want to overwhelm patients with continuous data, especially those who are only used to seeing a few readings per day from their traditional blood glucose meter.
In short, the Libre Pro would give health care providers a continuous, two-week snapshot of the patient’s glucose data. The consumer product is hotter than hot in the EU (rumors were flying when we were in the EU recently – some said as many as 50,000 people on the wait list for the product, which is not available to purchase in the EU for those new to the system).
Trial Length: Two weeks.
Trial Location: Seven locations across the US, including three in CA and one in MI, MO, NC, and TX.
Do you qualify? To qualify for this study, you must have type 2 diabetes, be 18 years or older, have an A1c between 6% and 12%, and have been on the same treatment regimen for the past six months (or, if diagnosed within the past six months, must not be taking medication both prior to and during the study), among other criteria. Exclusion criteria include an allergy to medical grade adhesive or isopropyl alcohol, pregnancy, or skin lesions/scarring on the upper arm (where the sensor is applied). Also, participants cannot be taking any of the following drug combinations:
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Metformin + Sulfonylurea + GLP-1 Agonist
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Metformin + Sulfonylurea + SGLT-2 Inhibitor
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Sulfonylurea + DPP-4 Inhibitor
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Sulfonylurea + GLP-1 Agonist
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Sulfonylurea + SGLT-2 Inhibitor
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Metformin + SGLT-2 Inhibitor + Insulin
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SGLT-2 Inhibitor + Insulin
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Rapid acting insulin (with the exception of rapid acting insulin present in premix formulations)
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Any combination of four or more drugs
A full list of the inclusion and exclusion criteria can be found at the clinicaltrials.gov site.
Where to get more information: For more information about the trial and its enrollment, you can contact Dr. Shridhara Alva Karinka (510-749-6393, [email protected]) or visit its posting on the clinicaltrials.gov website.
