DarioHealth, a publicly traded company from Israel, recently hit the U.S. market with Dario, a glucometer that plugs into the headphone jack of a smartphone and, with the help of a companion app, provides real-time advice to people with diabetes.
Notably, the FDA-cleared system automatically records blood-glucose readings, eliminating the need for users to enter values each time they test their blood sugar. “We’ve taken the consumer error aspect out of this equation,” said Scott Scolnick, director of professional and clinical sales for the U.S. market.
DarioHealth, founded in 2011 as LabStyle Innovations, introduced Dario in America a couple weeks ago after receiving Food and Drug Administration 510(k) clearance for the device and iPhone app December 2015. Scolnick said Dario hopes to have FDA clearance for an Android version by the end of the year.
Dario already is available for both the Apple iOS and Android platforms in Australia, New Zealand, Canada, Israel, as well as several European countries. The system received CE Mark certification in the European Union in September 2013.
Scolnick, based at DarioHealth U.S. headquarters in Burlington, Massachusetts, said Dario meets an ISO standard for portable glucometers of plus or minus 15 percent from what a professional laboratory would find. “So you’re getting an accurate reading,” he said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The app allows users to keep diaries about food and exercise, to, as Scolnick put it, “put blood-glucose readings in real context.” For further context, the app asks users whether the test is before or after a meal. “When I look at my next blood-glucose value, it helps me better understand why I got what I got,” said Scolnick, who has Type 1 diabetes.
The system also contains a database showing carbohydrate counts of half a million foods.
“When I look at a plate of food … I have to guess at how many carbs there are,” Scolnick said. “We’ve embedded this vast food database that takes the guesswork out of the equation.”
Dario provides alerts for hypoglycemic and hyperglycemic readings, based on user-specified parameters. “It will automatically generate a text message to up to four people,” according to Scolnick.
The system not only shows blood-glucose values, it has a link to Google Maps. This serves two purposes: It allows users to look for food or a place to exercise if necessary and it helps caregivers locate patients. “One of the main symptoms of hypoglycemia is confusion,” Scolnick noted.
This feature allows the parents of diabetic teens to “loosen the reins a bit,” he said.
The Dario meter retails for $29.99, while the app is a free download. DarioHealth also generates revenue by selling its own test strips.
DarioHealth is currently selling its product direct to consumers, and business has mostly been driven by social media so far, Scolnick reported. “As of today, it is a cash business,” he said.
However, the company is looking at other sales channels. “We are attending the major professional diabetes meetings,” Scolnick said. Dario also is talking to insurers, though it has not secured any reimbursement deals to date.
Photo: DarioHealth
