In recent years Apple stores began selling fitness devices other than those offered by long time partner Nike+. The company also added Withings' WiFi-enabled scale to its store shelves. Soon followed iHealth's iOS Blood Pressure Monitor dock and more. This week Cupertino's retail stores have begun selling Sanofi's iBGStar device, the first FDA cleared iPhone-enabled blood glucose meter. MobiHealthNews learned about the launch during an on-site meeting at Sanofi headquarters in Bridgewater, New Jersey this week.
MobiHealthNews first reported on the iBGStar back in September 2010 when Sanofi and its partner device maker AgaMatrix released the first images of the device, which was also known as AgaMatrix's Nugget device.
While the devices may still be making their way to some brick-and-mortar locations -- Sanofi expects them to be in the stores by May 15 -- Apple's online store and Walgreens.com are already selling the device. Apple is offering the iBGStar for about $100 while Walgreens has priced it at about $75. (An iPhone or iPod touch is not included, of course, and while the meter works without the device, much of its value would be lost without one.) Since Apple will not be selling testing strips for the device, its iBGStar package includes 50 strips, which explains the higher price. Walgreens' iBGStar package includes just 10 strips, but additional strips can be purchased at Walgreens or from the store's website. Sanofi says the prices work out to be about the same.
While Walgreens has an exclusive arrangement with Sanofi to sell the device and strips, Sanofi's Shawna Gvazdauskas, VP and Device Head for US Diabetes, said that any pharmacist can order the device for a patient through McKesson.
Sanofi's iBGStar is tiny. Some of the other bloggers and diabetes community leaders that attended Sanofi's demo day this week noted that the device's size alone is an impressive feature.
The device's companion app, called iBGStar Diabetes Manager App, launched on Apple's AppStore early last month. The app helps users analyze their glucose patterns over time, track eating and other activities that may have influenced their levels, and email data to care providers or others. The collected information is also displayed as scorecards that show individual test results in different colors that are coded to indicate high, low and within range blood glucose results. Readings from the iBGStar device are automatically loaded into the app when synched, and those readings are "locked" in -- users are not able to edit them. Those readings also are indicated by a lock symbol on the corner of their scorecard, while any manually entered readings are marked with an "x" to indicate that they are editable and were manually entered. Sanofi expects that information to help care providers who might like to know which readings came from the device and were not edited.
Sanofi acknowledged that it is targeting a very specific group with an iPhone or iPod touch-based glucose meter. The company believes the number of potential users is about 1.6 million in the United States. When Sanofi first partnered with AgaMatrix to develop the device back in March 2010, AT&T had an exclusive for the iPhone. Once Verizon Wireless began offering the iPhone and -- more recently -- Sprint, Sanofi saw its potential iBGStar user base rise considerably.
Sanofi also said that Apple is excited about the iBGStar device. Apple included the iBGStar device in a recent "healthcare enterprise" roadshow for medical professionals. The presentation featured just three iOS-enabled devices and apps, according to Sanofi. One featured device was Withings' WiFi-enabled weight scale. Two of them were Sanofi offerings: the iBGStar and the company's GoMeals app, a nutrition tracking app for people with diabetes. Sanofi says the app, which launched in late 2009, now has 400,000 downloads. Apple suggested that Sanofi find ways to integrate the GoMeals app with the iBGStar Diabetes Manager app, according to the company, and it plans to do so.
While the current iteration of Sanofi iBGStar Diabetes Manager app does not include any automated coaching like WellDoc's DiabetesManager program, Sanofi's Gvazdauskas said that the two companies are already exploring ways to collaborate. No firm plans for a partnership have been officially announced yet, however. Adding services is an important next step of Sanofi's three-prong diabetes franchise strategy, which includes "molecules", devices, and services. The company is likely to offer some kind of discount or incentive to buy the iBGStar device to those who also use its diabetes drugs. While this is its first device, Sanofi expects to develop others.
Another wireless-enabled blood glucose device came up during the discussion at Sanofi's event this week: Telcare. Telcare's BGM was the first FDA-cleared cellular-enabled blood glucose meter. Sanofi's Gvazdauskas said she was impressed with that company's cloud-based platform and saw an opportunity to partner with Telcare to leverage its platform in the future.
Given the amount of press the iBGStar has already received pre-launch, Gvazdauskas said that Sanofi has already heard from a number of very interested customers. Self-insured employers, she said, were one group that seemed especially interested. Healthcare providers are eager to leverage iBGStar to track patients post-discharge to determine if, for example, the patient is being compliant with their treatment plan to test a certain number of times a day.
So what took so long? MobiHealthNews and others have been writing about the iBGStar for years. Gvazdauskas said the device entered the FDA's regulatory machine when the agency was adding new requirements for medical device clearance -- including new infection control policies --- that slowed the process down. Gvazdauskas also said that her team has been asked many times why it has taken so long to commercially launch the device after securing FDA clearance last December.
She said Sanofi waited because it wanted to ensure there was adequate shelf space available to meet the demand.